NRx Pharmaceuticals

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NRx Pharmaceuticals is advancing its preservative-free ketamine-based therapies, KETAFREE(TM) and NRX-100, through distinct regulatory pathways. The company has refiled an Abbreviated New Drug Application (ANDA) for KETAFREE(TM) following FDA approval to eliminate a harmful preservative. This move aims to provide a safer ketamine formulation for hospital and outpatient use. Additionally, NRX-100 is being developed under a New Drug Application (NDA) for treating suicidal depression, with Fast Track Designation granted by the FDA for expedited review. NRx is also working on NRX-101, a Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain, with plans for an NDA filing for Accelerated Approval.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, is advancing its ketamine-based therapies, KETAFREE(TM) and NRX-100, through distinct regulatory and commercial pathways. The company has refiled an Abbreviated New Drug Application for KETAFREE(TM), following FDA approval of its Suitability Petition to remove a neurotoxic preservative. NRX-100, aimed at treating suicidal ideation in depression, holds Fast Track Designation and may qualify for the FDAs National Priority Voucher Program. Additionally, NRx is working on NRX-101, a Breakthrough Therapy for suicidal bipolar depression. These developments were discussed by CEO Dr. Jonathan Javitt at a recent virtual equity conference.

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Roadzen Inc., a global leader in AI-powered mobility and insurance innovation, is featured on New to The Street, a business television brand airing on Bloomberg and Fox Business. The show, which aims to highlight public and private companies shaping the future of their industries, will broadcast nationwide. This exposure is likely to positively impact Roadzen Inc. by increasing its visibility and potentially attracting new customers or partners. The episode will be available for replay on New to The Streets YouTube channel and shared across various social media platforms, further amplifying its reach.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has re-filed an Abbreviated New Drug Application for KETAFREE, a preservative-free intravenous ketamine formulation. This follows FDA approval of their Suitability Petition. The company is also advancing NRX-100, a preservative-free ketamine formulation for suicidal depression, which has received Fast Track Designation. Additionally, NRx is developing NRX-101, an oral medication for suicidal bipolar depression, holding Breakthrough Therapy Designation. With rising demand for ketamine and ongoing drug shortages, NRx aims to capture a significant market share while setting a new standard in preservative-free IV formulations.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that its Founder, Chairman, and CEO, Dr. Jonathan Javitt, will present at the Noble Capital Markets Emerging Growth Virtual Equity Conference. The company is preparing to launch a low-dose D-Cycloserine product to enhance Transcranial Magnetic Stimulation for depression. NRx is expanding its clinical operations in Florida and collaborating with the U.S. Department of Veterans Affairs to treat veterans with suicidal depression and PTSD. The company is developing therapeutics based on its NMDA platform, including NRX-100 and NRX-101, which have received Fast Track and Breakthrough Therapy Designations, respectively. NRx has filed an Abbreviated New Drug Application for NRX-100 and initiated a New Drug Application filing.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, is set to present at the Noble Capital Markets Emerging Growth Virtual Equity Conference. The company, along with its wholly-owned subsidiary HOPE Therapeutics, will discuss their plans to launch a low-dose D-Cycloserine (DCS) product, which has shown to enhance the effectiveness of Transcranial Magnetic Stimulation (TMS) in treating depression. The presentation will also cover their new clinical operations in Florida and collaboration with the US Department of Veterans Affairs to treat veterans with suicidal depression and PTSD. NRx Pharmaceuticals is actively involved in neuroplastic treatments for suicidal depression, as highlighted in a recent summit attended by key stakeholders. The company is developing therapeutics for central nervous system disorders and has filed applications for NRX-100 and NRX-101, which have received Fast Track and Breakthrough Therapy Designations.

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NRx Pharmaceuticals announced the re-filing of its Abbreviated New Drug Application with the U.S. FDA for KETAFREE(TM), a preservative-free IV ketamine formulation. This follows the FDAs approval of its Suitability Petition. The company is targeting a significant market opportunity, with the U.S. ketamine market estimated at $750 million annually and projected to reach $3.35 billion globally by 2034. NRx is seeking priority review due to an ongoing drug shortage, emphasizing its safer formulation manufactured with Nephron Pharmaceuticals. The company is in the clinical stage, focusing on therapeutics for central nervous system disorders, including suicidal depression and PTSD.

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NRx Pharmaceuticals, Inc. announced the re-filing of its Abbreviated New Drug Application (ANDA) to the FDA for KETAFREE™, a preservative-free IV ketamine formulation. This move aligns with FDAs approval of NRxs Suitability Petition for the proposed strength of preservative-free ketamine. The company aims to address the current US ketamine shortage and capture a significant market share, with the global ketamine market projected to grow to $3.35 billion by 2034. NRx is seeking priority review from the FDA and has filed a citizens petition to remove benzethonium chloride, a toxic preservative, from ketamine formulations.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced that the FDA has granted a Suitability Petition for its preservative-free ketamine product, KETAFREE™. This approval allows NRx to re-file its Abbreviated New Drug Application (ANDA) for KETAFREE™, which aims to replace the toxic preservative in current ketamine products. The company is also developing NRX-100 for suicidal depression and PTSD, which has received Fast Track Designation. The FDAs decision supports the companys goals of re-shoring drug manufacturing and removing toxic preservatives, aligning with current U.S. policy objectives. The market for ketamine is estimated at $750 million, and NRx aims to capture a significant share with its innovative offerings.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has received FDA approval for its Suitability Petition for KETAFREE(TM), a preservative-free ketamine product. This approval allows NRx to re-file its Abbreviated New Drug Application, aligning with federal priorities to re-shore sterile drug manufacturing and eliminate harmful preservatives. The company is also advancing NRX-100, a non-generic ketamine formulation for suicidal depression and PTSD, which has been awarded Fast Track Designation. Additionally, NRX-101 has received Breakthrough Therapy Designation for treating suicidal bipolar depression. The ketamine market is estimated at $750 million, indicating significant growth potential for NRx Pharmaceuticals.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has received FDA approval for a Suitability Petition, allowing them to re-file an Abbreviated New Drug Application for their preservative-free ketamine product, KETAFREE™. This development aligns with the administrations objectives to re-shore strategically important drugs and eliminate toxic preservatives. The market for ketamine is valued at $750 million, and NRx aims to capture a portion with KETAFREE™. Additionally, they plan to introduce a non-generic ketamine formulation for treating suicidal depression and PTSD. The FDAs approval is seen as a pivotal milestone, enhancing NRxs reputation for innovation in mental health and patient safety.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced the acquisition of Dura Medical, a provider of interventional psychiatry services in Florida. This acquisition is part of NRxs strategy to expand its network of clinics, with plans to include more than eight locations across Florida. Dura Medical offers treatments for various mental health conditions, including depression and PTSD, using innovative therapies such as Ketamine Infusion Therapy and Transcranial Magnetic Stimulation. Stephen Durand, the founder of Dura Medical, has been appointed as the Director of Florida Clinic Operations. NRx is also developing therapeutics for central nervous system disorders and has filed applications for its products NRX-100 and NRX-101.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced the acquisition of Dura Medical, which will enhance its service offerings in precision psychiatry for severe depression and PTSD. Dura Medical, founded in 2018, provides innovative treatments such as Ketamine Therapy and Transcranial Magnetic Stimulation (TMS) and is revenue-generating and EBITDA positive. The acquisition aims to expand services to more than 8 locations along Floridas West Coast, with plans to cover the entire Florida Peninsula. Stephen Durand, founder of Dura Medical, will serve as Director of Clinic Operations for HOPE Therapeutics, a subsidiary of NRx. The acquisition is part of a broader strategy to provide comprehensive care to veterans and civilians, leveraging partnerships with the Veterans Affairs Community Cares Network.

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NRx Pharmaceuticals presented plans for the Fall 2025 launch of HOPE Therapeutics clinics at a symposium sponsored by the Global Passion Project and Rockefeller Capital. The clinics will offer a unique residential program targeting suicidal depression, PTSD, traumatic brain injury, and cognitive dysfunction. The program will combine neuroplastic drugs, transcranial magnetic stimulation, hyperbaric oxygen therapy, and nutritional therapy. Matthew Rockefeller joined the advisory board of HOPE Therapeutics. The initiative aims to provide a comprehensive treatment approach with a response rate of over 90%. The symposium emphasized collaboration and innovation to tackle global mental health challenges.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced its participation in the H.C. Wainwright’s 27th Annual Global Investment Conference. The companys CEO, Jonathan Javitt, will engage in a fireside chat and one-on-one investor meetings. NRx is developing therapeutics for central nervous system disorders, including suicidal depression, chronic pain, and PTSD, with products like NRX-100 and NRX-101. The company has received Fast Track and Breakthrough Therapy Designations for its treatments and has filed applications for NRX-100. HOPE Therapeutics, a subsidiary, aims to establish a network of interventional psychiatry clinics. The event is scheduled for September 8, 2025.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that the FDA has granted Fast Track designation to its intravenous ketamine formulation, NRX-100, for treating suicidal ideation in patients with depression, including bipolar depression. This designation significantly expands the potential patient pool to an estimated 13 million Americans. Clinical trials have shown rapid and significant reductions in suicidal ideation with NRX-100. The Fast Track status makes NRX-100 eligible for Accelerated Approval and the Commissioners National Priority Voucher program. The U.S. market for suicidal depression is estimated at over $3 billion annually. NRx is preparing an expanded access policy and seeking meetings with FDA leadership for data submission alignment.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, is advancing its NMDA-based therapies for central nervous system disorders. The company has achieved significant regulatory milestones, including an expanded FDA Fast Track designation for its NRX-100 formulation and the submission of manufacturing data for NRX-101s New Drug Application. Additionally, NRx is expanding its clinical services through its subsidiary HOPE Therapeutics, which recently acquired Dura Medical and is acquiring a stake in Cohen and Associates clinics. These strategic moves aim to enhance patient care and drive revenue growth. Despite the potential of NRXP as an investment, the article suggests that certain AI stocks may offer greater upside potential.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has announced plans to launch HOPE Therapeutics clinics in Fall 2025, focusing on treating suicidal depression, PTSD, and cognitive dysfunction through a combination of neuroplastic drugs and therapies. The company has raised $8.8 million from biotech investors to support this initiative. The clinics will offer a unique residential program incorporating treatments like ketamine, transcranial magnetic stimulation, and hyperbaric oxygen therapy. Matthew Rockefeller has joined the HOPE Therapeutics Advisory Board, enhancing the companys leadership. The initiative aims to provide comprehensive treatment options with a targeted response rate of over 90%.

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NRx Pharmaceuticals, Inc. is advancing its clinical-stage biopharmaceutical efforts with the upcoming launch of HOPE Therapeutics clinics in Fall 2025. The clinics will offer innovative treatments for suicidal depression, PTSD, and cognitive dysfunction, combining neuroplastic drugs with therapies like transcranial magnetic stimulation and hyperbaric oxygen. The company recently raised $8.8 million from biotech investors, and Matthew Rockefeller joined the HOPE Therapeutics Advisory Board. The initiative aims to achieve over 90% response rates by integrating various treatments under one umbrella. The announcement was made at a symposium attended by leading family offices, emphasizing collaboration to tackle global mental health challenges.

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New to The Streets, a prominent financial media platform, announced the broadcast of Episode 684 on Bloomberg Television. This episode, airing on August 30, 2025, features a diverse lineup of industry leaders and innovators, including TON Strategy Company, Laser Photonics, and Mercurity Fintech. The episode is supported by sponsored commercials from companies like NRx Pharma and Synergy CHC. Vince Caruso, CEO of New to The Streets, emphasized the platforms commitment to delivering compelling stories of strategy, innovation, and leadership. The platform is known for providing guaranteed media exposure across various platforms, making it a trusted source for CEOs and innovators to share their stories.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced the expansion of its access policy for NRX-100, a preservative-free ketamine, following the FDAs Fast Track designation for treating suicidal ideation in depression, including bipolar depression. This designation indicates that NRX-100 may address an unmet need based on preliminary data. The company is committed to advancing its clinical development program and making NRX-100 available to patients with limited treatment options. NRx is also developing NRX-101, which has received Breakthrough Therapy Designation for treating suicidal bipolar depression. The company plans to file an NDA for Accelerated Approval for NRX-101 and has initiated a New Drug Application filing for NRX-100.

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NRx Pharmaceuticals, Inc. has announced that the FDA has granted Fast Track designation for its drug NRX-100, aimed at treating suicidal ideation in patients with depression, including bipolar depression. The company is offering NRX-100 on an expanded access basis for patients with serious or life-threatening suicidal depression who have not responded to existing treatments. This designation indicates that NRX-100 has the potential to address an unmet medical need. The expanded access program allows physicians to apply for the drug on behalf of eligible patients. This development is a positive step for NRx Pharmaceuticals as it progresses through clinical trials.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has submitted a Citizen Petition to the FDA to prohibit the use of benzethonium chloride in ketamine products due to its toxicity risks. The company is advocating for the removal of this preservative, which is not considered safe for pharmaceutical use. NRx has developed a preservative-free ketamine product, NRX-100, and is seeking FDA approval for it, along with an oral NMDA-targeting drug, NRX-101. The petition highlights the potential health risks associated with benzethonium chloride, which has already been removed from other products by the FDA.

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NRX Pharmaceuticals Inc reported a net loss of $17.5 million for Q2 2025, an increase from $7.9 million in Q2 2024, primarily due to a $12 million non-cash charge. The company has strengthened its balance sheet by securing long-term healthcare specialist investors and raised $6.5 million through a registered direct offering. NRX is progressing with three drug approval applications, including NRX-100 and NRX-101, with the FDA granting an expansion of the Fast Track designation for NRX-100. However, the company faces liquidity concerns with only $2.9 million in cash and challenges in commercializing its products. The FDAs response to a petition regarding ketamine formulations could impact NRX-100s market potential.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, reported financial results for Q2 2025 and provided a corporate update. The company is advancing its lead programs, including NRX-100 and NRX-101, which have received FDA Fast Track and Breakthrough Therapy Designations, respectively. A strategic investor group led by B Group Capital has committed capital through a purchase of restricted common stock, expected to support key regulatory milestones and scale HOPE Therapeutics. NRx has filed regulatory documents for NRX-100 and NRX-101, aiming to treat suicidal depression and bipolar depression. The company is leveraging its NMDA platform to develop therapeutics for central nervous system disorders.

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NRx Pharmaceuticals, Inc. has received an expanded Fast Track Designation from the FDA for its drug NRX-100, broadening its market potential to 13 million Americans. The company is actively pursuing FDA approval for NRX-100, a preservative-free intravenous ketamine, and has filed several applications and petitions with the FDA. Additionally, NRx is involved in multiple acquisitions, including Dura Medical and NeuroSpa TMS Holdings, supported by $7.8 million in debt financing. HOPE Therapeutics, a related entity, is also pursuing strategic investments. These developments indicate a positive growth trajectory for NRx Pharmaceuticals, with significant advancements in drug development and strategic acquisitions.

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NRx Pharmaceuticals, through its subsidiary HOPE Therapeutics, has received clearance to acquire Dura Medical LLC, a company specializing in mental health and chronic pain treatment. This acquisition will expand NRxs network in Florida and integrate Duras expertise in psychedelic medications and neuroplastic technologies for treating conditions like suicidal depression and PTSD. NRx is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders. The company is advancing its NMDA platform and has several drug applications in progress, including NRX-101 and NRX-100, both of which have received FDA designations. This strategic acquisition is expected to enhance NRxs capabilities and market presence.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has received Fast Track designation from the FDA for its drug NRX-100, aimed at treating suicidal ideation in patients with depression, including bipolar depression. This expands upon a previous 2017 designation for NRX-101. The FDAs decision is based on promising preliminary data from controlled trials, which showed significant reductions in suicidal ideation. NRx plans to post an expanded access policy and meet with FDA leadership to finalize data for submission under the Accelerated Approval pathway. The company is also pursuing applications for the Commissioner’s National Priority Voucher Program.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has filed a Citizen Petition with the FDA to remove Benzethonium Chloride (BZT) from all ketamine products in the U.S. due to its toxicity. The company is developing a preservative-free ketamine formulation and pursuing FDA approval for its use in treating suicidal depression. NRx is also working on NRX-101, a non-opioid treatment for chronic pain and bipolar depression, and has initiated a New Drug Application for NRX-100 (IV ketamine) for suicidal depression. The company has received Fast Track Designation from the FDA for ketamine development, aligning with federal efforts to eliminate toxic additives from drugs.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced it will release its second quarter 2025 financial results on August 19, 2025. The company is developing therapeutics for central nervous system disorders, including suicidal depression, chronic pain, and PTSD, based on its NMDA platform. NRx is advancing NRX-100 and NRX-101, with the latter having received Breakthrough Therapy Designation. The company plans to file an NDA for Accelerated Approval for NRX-101. Additionally, NRx has filed an ANDA and initiated a New Drug Application for NRX-100, supported by clinical trials conducted under the US National Institutes of Health and the Government of France. The company is focused on achieving regulatory milestones and has not predicted future regulatory outcomes.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, is advancing its NMDA platform for treating central nervous system disorders. The company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101. Additionally, NRx has initiated a New Drug Application filing for NRX-100 (IV ketamine) for suicidal depression, supported by clinical trials and data from French health authorities. The company has been awarded Fast Track Designation by the US FDA for ketamine development. CEO Prof. Jonathan Javitt will discuss neuroplasticity in CNS disorder treatment at the BTIG Virtual Biotechnology Conference.

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NRx Pharmaceuticals, Inc. announced that the FDA has granted Fast Track Designation for NRX-100, a treatment for suicidal ideation in patients with depression, including bipolar depression. This designation expands the potential patient population significantly and recognizes NRX-100s potential to address an unmet medical need. Supported by large-scale trials, NRX-100 has shown rapid reductions in suicidal ideation. The company plans to seek Accelerated Approval and Priority Review, aiming to make the treatment widely accessible. The preservative-free formulation of NRX-100 offers safety advantages and is manufactured in the U.S. NRx Pharmaceuticals is committed to addressing the national crisis of suicide.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced plans to release its second quarter 2025 financial results on August 14, 2025. The company is focused on developing therapeutics for central nervous system disorders, including suicidal depression, chronic pain, and PTSD. NRx is advancing its NMDA platform with products like NRX-100 and NRX-101, which have received Fast Track and Breakthrough Therapy Designations, respectively. The company is preparing to file an NDA for Accelerated Approval for NRX-101 and has initiated a New Drug Application for NRX-100. These developments highlight NRxs progress in regulatory milestones and its commitment to addressing mental health challenges.

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NRx Pharmaceuticals, Inc. has received Fast Track designation from the FDA for its drug NRX-100, aimed at treating suicidal ideation in patients with depression, including bipolar depression. This designation significantly expands the drugs addressable population, highlighting its potential to meet an unmet medical need. The FDAs decision aligns with the eligibility for the Commissioner’s National Priority Voucher Program, which could expedite the review process. Clinical trials have shown promising results, with significant reductions in suicidal ideation. The designation is a positive development for NRx Pharmaceuticals, potentially accelerating the drugs path to market.

growth-positive

The article discusses several companies featured on a business television program, highlighting their recent developments. NRx Pharmaceuticals is seeking FDA approval for a preservative-free ketamine formulation, aiming to treat suicidal depression. BioVie Inc. is conducting Phase 3 clinical trials for Bezisterim, targeting Parkinsons disease and long COVID symptoms. FLOKI is launching a trading bot and a blockchain game, Valhalla, which integrates real-world asset utility. PetVivo Holdings, in partnership with Commonwealth, is introducing SPRYNG™ with OsteoCushion™ Technology to enhance equine wellness in horse racing. These developments indicate growth opportunities for the companies involved.

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HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, has received approval from Floridas Agency for Health Care Administration to proceed with the acquisition of Dura Medical. This acquisition is expected to enhance HOPEs revenue and EBITDA. Dura Medical, founded in 2018, specializes in precision psychiatry services for severe depression, PTSD, and related CNS disorders, offering treatments such as Ketamine therapy and Transcranial Magnetic Stimulation. The acquisition aligns with HOPEs mission to expand its mental health services, particularly for veterans, through the Veterans Affairs Community Cares Network. The acquisition is seen as a strategic move to expand HOPEs presence in Florida and improve mental health care access.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has filed a Citizen Petition with the FDA to remove Benzethonium Chloride, a toxic preservative, from all ketamine products sold in the U.S. The company has developed a preservative-free ketamine preparation, demonstrating long-term stability and sterility, and has filed an Abbreviated New Drug Application with the FDA. NRx is also seeking approval for ketamine to treat suicidal depression. The move aligns with FDA priorities to remove toxic additives from the drug supply. The company is preparing for high-volume manufacturing in the U.S. while awaiting generic approval.

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PetVivo Holdings Inc. is experiencing growth through the commercial rollout of its SPRYNG with OsteoCushion Technology, now adopted by over 1,200 veterinary clinics across the United States. The company has also entered a new partnership with Commonwealth Thoroughbreds to advance equine joint wellness and performance. This expansion reflects PetVivos leadership in the animal therapeutics market, offering a drug-free solution to joint pain. The article highlights the companys strategic moves and partnerships, contributing to its positive growth trajectory.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, is developing therapeutics for central nervous system disorders. The company is focusing on NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression. NRx plans to file an NDA for Accelerated Approval for NRX-101. Additionally, NRx has filed an ANDA for NRX-100 for ketamines approved indications and initiated a New Drug Application for suicidal depression. The company has been awarded Fast Track Designation by the US FDA for ketamine (NRX-100) and has filed a patent for its novel formulation. NRxs subsidiary, HOPE Therapeutics, is building a network of interventional psychiatry clinics.

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The article discusses the upcoming broadcast of Episode #680 of New to The Street, a national business television program on Bloomberg TV. The episode will feature interviews and updates from five innovative companies, including Arrive AI, which is redefining last-mile delivery using AI and automation. The program is supported by sponsoring partners like Arrive AI, MUSQ - The Music ETF, NRX Pharma, Commercialville TV, and The Sustainable Green Team. New to The Street is known for its extensive reach and influence in the financial media sector, offering companies significant brand exposure through its broadcasts and social media presence.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, is advancing its efforts to gain regulatory approval for NRX-100, an intravenous ketamine formulation for treating suicidal depression and PTSD. The company has filed an application under the FDAs National Priority Voucher program, which could expedite the review process. Additionally, an Abbreviated New Drug Application has been submitted for priority review. NRx is also developing NRX-101, a Breakthrough Therapy for bipolar depression and chronic pain, and plans to file for Accelerated Approval. The company has received Fast Track Designation for NRX-100 from the FDA, highlighting its potential to address urgent health needs.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, is advancing its growth strategy by expanding its network of mental health clinics through its subsidiary, HOPE Therapeutics. The company plans to invest $10.3 million to acquire clinics specializing in neuroplastic therapies, projected to generate $15 million in revenue in 2025. NRx is also progressing its NMDA-based therapies, NRX-100 and NRX-101, which have received expedited regulatory designations from the FDA. These therapies target suicidal depression and bipolar depression with suicidality or akathisia. NRx has initiated a New Drug Application for NRX-100 and plans to file for Accelerated Approval for NRX-101.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, through its subsidiary HOPE Therapeutics, has signed a binding letter of intent to acquire a 49% stake in Cohen and Associates, LLC, a neuropsychiatry clinic in Florida. This acquisition is expected to be immediately accretive to revenue and EBITDA, supporting HOPE Therapeutics expansion goal of reaching 30 clinics with a $100 million run rate by the end of 2025. Cohen and Associates, led by Dr. Rebecca Cohen, offers treatments for mood disorders, PTSD, and suicidal depression, including ketamine and TMS therapies. The acquisition positions Cohen as a foundational clinic in HOPEs growing network in the Sarasota-Bradenton region.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, is advancing its efforts to gain regulatory approval for NRX-100, an intravenous ketamine formulation for treating suicidal depression and PTSD. The company has applied for the FDAs newly established National Priority Voucher program, which aims to expedite the approval process for drugs addressing urgent U.S. health priorities. NRx has submitted comprehensive data and labeling for NRX-100, meeting the programs pre-qualification criteria. The company is also focusing on U.S.-based manufacturing to reduce foreign supply chain reliance. The FDAs new program, announced on June 17, 2025, prioritizes psychedelic drugs for mental health treatment, aligning with NRxs objectives.

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Compass Pathways announced the achievement of the primary endpoint in their Phase 3 COMP005 trial for COMP360, a synthetic psilocybin formulation for treatment-resistant depression. The trial showed a statistically significant reduction in symptom severity compared to placebo. The company plans to discuss these findings with the FDA, although the data has not yet been reviewed. The trial involved 258 participants across 32 sites in the U.S. and demonstrated consistent safety findings with no new safety concerns. The CEO highlighted the innovative potential of psilocybin in mental health care. Despite positive results, Evercore ISI downgraded Compass Pathways due to concerns about the durability of the treatments effects.

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HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, has announced a binding Letter of Intent to acquire a 49% interest in Cohen and Associates, a neuropsychiatry clinic in western Florida. This acquisition is expected to enhance HOPEs presence in the Sarasota-Bradenton area and is anticipated to be immediately accretive to revenue and EBITDA. Cohen and Associates, founded by Dr. Rebecca Cohen, is renowned for its comprehensive treatment offerings for CNS disorders. The acquisition aligns with HOPEs mission to deliver top-tier psychiatric care. The transaction is subject to standard closing requirements, with further details to be disclosed later.

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NRx Pharmaceuticals, through its subsidiary HOPE Therapeutics, has signed a Letter of Intent to acquire a 49% interest in Cohen and Associates, a leading interventional psychiatry clinic. This acquisition aims to bolster HOPEs regional growth and aligns with its mission to provide evidence-based mental health care. NRx is a clinical-stage biopharmaceutical company focused on developing treatments for central nervous system disorders. It is advancing NRX-101, an FDA-designated Breakthrough Therapy, and has initiated a New Drug Application for NRX-100, receiving Fast Track Designation from the FDA. The acquisition reflects NRxs strategic expansion in mental health services.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has applied for the FDA Commissioners National Priority Voucher (CNPV) for its drug NRX-100, a preservative-free ketamine formulation. This application is part of their strategy to expedite the drug approval process, with a decision anticipated by the end of 2025. The CNPV program, announced by FDA Commissioner Marty Makary, aims to prioritize drugs addressing national health priorities, potentially reducing review times significantly. NRx has complied with FDA requests for updated drug information and has previously submitted comprehensive data on NRX-100s stability and sterility. The company is optimistic about receiving accelerated approval, aligning with the FDAs focus on addressing health crises and unmet public health needs.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced a strategic investor relations partnership with astr partners, a firm specializing in life sciences. This collaboration aims to enhance NRxs visibility and strengthen its relationships within the investment community. NRx is currently focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD. The company plans to file an NDA for NRX-101, a Breakthrough Therapy designated by the FDA, for accelerated approval. The partnership with astr partners is expected to support NRx at a crucial point as they advance their neuropsychiatry therapies and expand their clinical care delivery through HOPE Therapeutics.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced a strategic investor relations partnership with astr partners, a firm specializing in life sciences. This collaboration aims to enhance NRxs visibility and engagement as it advances toward two NDA filings and an ANDA submission. NRx is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. The company also plans to file an NDA for NRX-100 (IV ketamine) for suicidal depression, having received Fast Track Designation from the FDA. The partnership with astr partners will support NRx in investor targeting and message development.

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The article discusses the nationwide broadcast of Show #672 on the Fox Business Network, featuring interviews with four innovative companies, including BioVie Inc. BioVie is highlighted as a clinical-stage biopharmaceutical company advancing treatments for neurodegenerative and liver diseases, with multiple Phase 3 trials underway. The show aims to provide investors with insights into the strategic goals and innovation roadmaps of these companies, emphasizing the diversity of innovation across Web3, biotech, and wellness sectors. The broadcast is part of New to The Streets efforts to deliver sponsored content and earned media to a wide audience.

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The article discusses the premiere of Episode #671 of New to The Street, a business television series that highlights innovation across various sectors. The episode features companies like Arrive AI, which is developing an AI-powered smart mailbox delivery platform, and NRX Pharmaceuticals, which is advancing treatments for CNS disorders. The show also includes sponsors like The Sustainable Green Team and PetVivo Holdings, Inc. The episode aims to provide national exposure to these innovative companies, blending sectors such as AI, healthcare, crypto, and wellness. The article emphasizes the shows role in amplifying the messages of these companies through national TV exposure.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced its participation in the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference in June 2025. The company, along with its subsidiary HOPE Therapeutics, will present its latest advances in developing therapeutics for central nervous system disorders. NRx is focusing on NRX-101, a Breakthrough Therapy for suicidal bipolar depression, and has filed an NDA for Accelerated Approval. Additionally, NRx has filed an ANDA for NRX-100, a preservative-free IV ketamine, and initiated a New Drug Application for its use in treating suicidal depression. The company has received Fast Track Designation from the FDA for NRX-100 and has filed a patent for its novel formulation.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has signed a definitive agreement to acquire Kadima Neuropsychiatry Institute. This acquisition is part of NRxs subsidiary HOPE Therapeutics strategy to establish a national network of interventional psychiatry clinics. The acquisition is expected to enhance revenue and EBITDA for NRx and HOPE, with plans to develop up to 30 clinics by the end of 2025. Kadima, known for its interventional psychiatry work, will serve as the clinical and operational template for the network. Dr. David Feifel, Kadimas founder, will join HOPE as Chief Medical Innovation Officer. NRxs pipeline includes FDA-designated treatments for bipolar depression and acute suicidality.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has entered into a 12-part media partnership with New to The Street, a leading financial news show. This partnership will feature monthly televised interviews with NRx CEO Dr. Jonathan Javitt, highlighting the companys advancements in life-saving therapies for conditions like suicidal depression and PTSD. The campaign includes media placements on major networks and extensive billboard exposure, aiming to increase public awareness of NRxs innovative treatments. The series will air on Fox Business and Bloomberg Television, reaching a vast audience. NRxs lead drug, NRX-101, has received FDA Breakthrough Therapy and Fast Track Designation, and the company is pursuing further approvals for its treatments.

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NRx Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) to the FDA for NRX-100, a preservative-free intravenous ketamine formulation. This move is part of the companys strategy to address the U.S. ketamine market, valued at $750 million, and expand its use for suicidal depression. NRx aims to secure priority review amid a national shortage and plans to advocate for preservative-free formulations due to safety concerns. The company is also developing NRX-101, a Breakthrough Therapy for suicidal treatment-resistant bipolar depression. NRx has been awarded Fast Track Designation by the FDA for ketamine development, highlighting its commitment to addressing central nervous system disorders.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, is advancing its preservative-free IV ketamine formulation, NRX-100, amidst a significant ketamine shortage in the US. The company has submitted an Abbreviated New Drug Application (ANDA) to the FDA and anticipates a priority review due to the current drug shortage. NRx aims to capture a significant share of the growing ketamine market, projected to reach $3.35 billion by 2034. The company is also filing a citizens petition with the FDA to remove benzethonium chloride, a known toxic preservative, from ketamine formulations. This initiative aligns with current health priorities and could lead to regulatory changes requiring all ketamine formulations to be preservative-free.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, is advancing its strategy to expand a nationwide mental health clinic network and progress toward FDA approval for its NMDA-based therapies targeting suicidal depression and bipolar disorder. The companys subsidiary, HOPE Therapeutics, has secured a $7.8 million debt financing term sheet with Universal Capital, contributing to a total expected financing of $10.3 million for acquisitions. This funding will support the acquisition of Dura Medical, Kadima, and NeuroSpa clinics, enhancing the delivery of neuroplastic therapies for depression and PTSD. NRx is also making regulatory progress for its therapies NRX-100 and NRX-101, with the FDA waiving a $4.3 million drug application fee.

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NRx Pharmaceuticals, Inc. has announced the acquisition of Kadima Neuropsychiatry Institute, marking a strategic expansion into mental health care. This acquisition is part of a plan to establish a $100 million network of interventional psychiatry clinics across the U.S. Kadima, known for its advanced clinical care and research, will serve as the clinical model for this expansion. The acquisition is expected to enhance revenue and profitability for NRx. Dr. David Feifel, Kadimas founder, will join HOPE Therapeutics as Chief Medical Innovation Officer. The company aims to acquire 30 clinics by 2025, focusing on comprehensive treatments for mental health conditions.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced the acquisition of Kadima Neuropsychiatry Institute in La Jolla, California. This acquisition is part of NRxs strategy to expand its presence in the mental health care sector through its subsidiary, HOPE Therapeutics. Kadima will serve as a clinical model for HOPEs planned network of interventional psychiatry clinics across the U.S. The acquisition is expected to be profitable and accretive to both revenue and EBITDA. Dr. David Feifel, Kadimas founder, will join HOPE as Chief Medical Innovation Officer. NRx aims to acquire 30 clinics by the end of 2025, projecting $100M in annual revenue.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, is set to present at the Wall Street Conference on May 21, 2025. The company will discuss its progress toward FDA approval for NRX-100, an intravenous ketamine formulation, and its strategic acquisition plans for HOPE clinics. NRx is focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression and PTSD. The company has initiated a New Drug Application for NRX-100 and plans to file for Accelerated Approval for NRX-101. NRx has received Fast Track Designation from the FDA for NRX-100, highlighting its potential in treating acute suicidality.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced its participation in the upcoming Wall Street Conference on May 21, 2025. The company will discuss its progress towards FDA approval for NRX-100, a preservative-free ketamine for treating suicidal depression, and its plans to acquire HOPE clinics. NRx is developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD. The company has initiated a New Drug Application for NRX-100 and plans to file for Accelerated Approval for NRX-101. NRx has received Fast Track Designation from the FDA for NRX-100 and has filed a patent for its novel formulation.

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The article discusses the growing advocacy for the use of psychedelics to treat PTSD, depression, and suicidality among veterans, led by Rep. Morgan Luttrell and other lawmakers. NRx Pharmaceuticals and its subsidiary HOPE Therapeutics are highlighted as leaders in this field, developing ketamine-based treatments for acute suicidality and major depression. Despite some resistance and regulatory setbacks, such as the FDAs rejection of an MDMA therapy from Lykos Therapeutics, the movement is gaining momentum. The article emphasizes the potential for NRx Pharmaceuticals to benefit from this shift in legislative and public support for psychedelic therapies.

growth-positive

NRX Pharmaceuticals Inc reported a net loss of $5.5 million for Q1 2025, showing a reduction from the previous year. The company is advancing its lead candidates, NRX-100 and NRX-101, in the FDA regulatory process, indicating progress towards potential drug approvals. They have developed a patentable pH neutral version of ketamine, which could offer long-term market exclusivity. Despite financial challenges, NRX Pharmaceuticals has reduced expenses and increased cash reserves. HOPE Therapeutics, a subsidiary, is expected to become profitable soon with plans for a national network of interventional psychiatry clinics. However, the company faces risks related to drug approval and commercialization, and concerns about ketamines long-term safety.

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NRx Pharmaceuticals reported a Q1 2025 net loss of $5.5 million, an improvement from the previous year. The company is advancing its lead programs, NRX-100 and NRX-101, for treating suicidal and bipolar depression. NRX-101 is anticipated to receive a PDUFA date by year-end, while NRX-100 has initiated a New Drug Application filing. The company received a Fast Track Designation for NRX-100 from the FDA. Additionally, subsidiary HOPE Therapeutics secured $10.3 million in acquisition funding to support a national psychiatry clinic rollup. NRx expects its current capital to sustain operations through the end of the year.

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HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, has signed a term sheet with Universal Capital, LLC to secure $7.8 million in acquisition capital. This funding is part of a $10.3 million acquisition strategy to expand HOPEs national rollup of interventional psychiatry clinics, including the acquisitions of Dura Medical, Kadima, and NeuroSpa. These clinics specialize in neuroplastic treatments like ketamine and transcranial magnetic stimulation (TMS) for severe depression and PTSD. The FDA has approved TMS devices and a nasal form of ketamine for treatment-resistant depression, and NRx is seeking FDA approval for intravenous ketamine. The clinics also serve veterans through contracts with the Veterans Health Administration.

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NRx Pharmaceuticals is advancing its plans to obtain FDA approval for two new drugs, NRX-100 and NRX-101, and is developing a network of clinics focused on neuroplastic therapies for severe depression and PTSD. The company completed a convertible note offering and a registered direct equity offering to an institutional investor, providing sufficient cash to support operations through 2025. NRx plans to acquire Kadima Neuroscience Institute, Dura Medical, and Neurospa TMS Holdings, with expected revenues of $15 million. In partnership with BTIG, NRx is implementing a rollup acquisition initiative and has executed a term sheet for debt financing and strategic investment totaling $10.3 million.

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NRx Pharmaceuticals Inc., a clinical-stage biopharmaceutical company, is set to report its first quarter 2025 financial results on May 15. The company recently announced that its subsidiary, HOPE Therapeutics, has signed a definitive agreement to acquire Kadima Neuropsychiatry Institute, a leader in psychedelic and neuroplastic research. This acquisition is expected to serve as a model for HOPEs national clinic rollout. NRx is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. The company is also filing a New Drug Application for NRX-100, a preservative-free IV ketamine, for treating suicidal depression. NRx has been awarded Fast Track Designation by the FDA for ketamine development.

growth-positive

HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, Inc., has signed a definitive agreement to acquire the Kadima Neuropsychiatry Institute. Kadima is a leading site for CNS and psychedelic research and will serve as a clinical model for HOPEs treatment offerings. The acquisition is expected to be accretive to revenue and EBITDA for both NRx and HOPE. Dr. David Feifel, a pioneer in interventional psychiatry, will join HOPE as Chief Medical Innovation Officer. Kadima is profitable and forecasts continued growth, offering treatments for CNS disorders such as suicidal depression and PTSD. The acquisition will enhance HOPEs capabilities in neuroplastic therapies.

growth-positive

NRx Pharmaceuticals announced the acquisition of Kadima Neuropsychiatry Institute through its subsidiary, HOPE Therapeutics. Kadima is a profitable clinic specializing in interventional psychiatry treatments for CNS disorders. The acquisition will serve as a clinical model for future HOPE clinics. Dr. David Feifel, Kadimas founder, will join HOPE as Chief Medical Innovation Officer. NRx is a clinical-stage biopharmaceutical company developing therapeutics for CNS disorders, including NRX-101, which has FDA Breakthrough Therapy designation. They are also filing an NDA for NRX-100 for suicidal depression. The acquisition is subject to customary conditions and financing.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced it will release its first quarter 2025 financial results on May 15, 2025. The company is developing therapeutics based on its NMDA platform for central nervous system disorders, including suicidal bipolar depression and chronic pain. NRx is working on NRX-101, an FDA-designated Breakthrough Therapy, and plans to file an NDA for Accelerated Approval. Additionally, NRx has initiated a New Drug Application for NRX-100 (IV ketamine) for suicidal depression, with Fast Track Designation from the FDA. HOPE Therapeutics, a subsidiary, is building a network of interventional psychiatry clinics.

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Compass Pathways reported a first-quarter loss per share of (24c), which was better than analyst estimates of (49c). The company has a strong cash position of $260.1M as of March 31, sufficient to fund operations through the 26-week data read-out from the COMP006 study expected in late 2026. The company is advancing its pivotal phase 3 COMP360 program for treatment-resistant depression, with a 6-week data readout anticipated in late June. GH Research and Mind Medicine also reported their Q1 results, with Mind Medicine actively enrolling patients in its phase 3 trials for MM120 ODT in General Anxiety Disorder and Major Depressive Disorder. The company aims to commercialize its breakthrough therapy for over 50 million people in the U.S.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, is hosting an investor event to discuss strategic initiatives, including the expansion of HOPE Therapeutics interventional psychiatry clinics and advancements in their clinical pipeline. Key topics include recent acquisitions of HOPE clinics, integration of digital health solutions, and the status of the New Drug Application (NDA) for NRX-100 following an FDA filing fee waiver. The company is also preparing to file an NDA for NRX-101, a Breakthrough Therapy for bipolar depression. The event underscores NRxs commitment to mental health innovation and regulatory progress.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has filed a patent application for NRX-100, a preservative-free intravenous ketamine formulation targeting suicidal depression. The patent could provide exclusivity through 2045 if granted. NRX-100 is designed without preservatives linked to toxicity and has shown room temperature shelf stability, potentially qualifying it for FDA Orange Book listing. This filing supports the companys NDA submission strategy and complements the FDA Fast Track Designation of companion drug NRX-101. NRx is developing therapeutics based on its NMDA platform for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD. The company plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has filed a patent application for NRX-100, a preservative-free intravenous ketamine formulation aimed at treating suicidal depression. The patent, if granted, would provide exclusivity until 2045 and potentially allow NRX-100 to be listed in the FDA Orange Book. This filing is part of NRxs strategy to advance safe and effective treatments for suicidal depression, building on their recent NDA filing and Fast Track Designation for NRX-101. The company emphasizes the elimination of benzethonium chloride, a compound with safety concerns, in their formulation. NRx is committed to completing their NDA submission this quarter, supported by a recent FDA fee waiver.

growth-positive

NRx Pharmaceuticals, Inc. announced that it received a waiver from the FDA, exempting it from a $4.3 million New Drug Application (NDA) filing fee for its drug NRX-100, a preservative-free ketamine preparation. This waiver is significant as it allows the company to proceed with its NDA filing by Q2 2025 using existing resources. NRX-100, along with NRX-101, has been granted Fast Track designation by the FDA for treating suicidal bipolar depression. The company aims to provide this treatment to a broader audience, as ketamine is currently only approved as an anesthetic and not reimbursed for treating depression. The waiver and potential FDA approval could lead to long-term exclusivity for NRx Pharmaceuticals.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced its participation in an H.C. Wainwright fireside discussion. The company is developing NRX-101, an investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality. Additionally, NRx is filing a New Drug Application for NRX-100 (IV ketamine) for suicidal depression, supported by clinical trials and data from French health authorities. The company has been awarded Fast Track Designation by the US FDA for ketamine development. HOPE Therapeutics, a subsidiary, aims to develop a network of interventional psychiatry clinics.

growth-positive

HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, Inc., has announced a non-binding term sheet with a global medical device manufacturer for a $2.5 million investment to purchase Series A Convertible Preferred Stock at a $50 million pre-money valuation. This investment aims to support the expansion of HOPEs network of interventional psychiatry clinics, which focus on treating suicidal depression and PTSD using ketamine, TMS, and other modalities. The investment is expected to close alongside HOPEs recent clinic acquisitions, enhancing their strategy to meet the unmet needs of patients with severe depression and PTSD.

growth-positive

HOPE Therapeutics, Inc., an interventional psychiatry network owned by NRx Pharmaceuticals, announced the acquisition of Dura Medical. This acquisition, along with the previously announced Neurospa network, aims to provide comprehensive mental health services on Floridas west coast. Dura Medical, founded in 2018, specializes in precision psychiatry services, including Ketamine Therapy and Transcranial Magnetic Stimulation, for treating severe depression and PTSD. The acquisition aligns with HOPEs mission to expand its services and reduce suicide rates, particularly among veterans. Stephen Durand, founder of Dura Medical, will serve as Director of Clinic Operations for HOPE in Florida. The acquisition is expected to enhance HOPEs service offerings and expand its reach in the mental health sector.

growth-positive

HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, Inc., has signed a binding Letter of Intent to acquire a majority interest in Neurospa TMS Holdings, LLC. Neurospa operates six interventional psychiatry clinics on Floridas Gulf Coast, offering treatments such as Ketamine Infusion Therapy, Transcranial Magnetic Stimulation (TMS), and Spravato®. The acquisition is expected to be accretive to HOPEs revenue projections for 2025, enhancing its network in Florida. Neurospas team will join HOPE, contributing to its mission of providing comprehensive psychiatric care. TMS is an FDA-approved procedure, and the acquisition aligns with HOPEs strategy to expand its services and reach.

growth-negative

The article discusses recent developments in psychedelic stocks, focusing on atai Life Sciences and NRx Pharmaceuticals. atai Life Sciences reported a fourth-quarter loss, with cash reserves significantly reduced compared to the previous year. However, a recent equity offering raised $59.2M, extending their financial runway into 2027. The company is focused on advancing its Phase 2 clinical trials for VLS-01 and EMP-01, with results expected in 2026. NRx Pharmaceuticals also reported a loss but highlighted strategic advancements, including a New Drug Application for NRX-100 and progress towards accelerated approval for NRX-101. Both companies are making strides in mental health treatments, despite financial challenges.

growth-positive

NRX Pharmaceuticals Inc has made significant strides in its drug development efforts, notably with its preservative-free intravenous ketamine, NRX-100, and the combination drug NRX-101. The company has raised $8.5 million in recent financings and is working towards profitability by the end of 2025. Despite challenges in the capital market and concerns over the safety of repeated ketamine use, NRX Pharmaceuticals is preparing an accelerated NDA filing and expanding its subsidiary, HOPE Therapeutics, by acquiring profitable clinics. The company is also seeking commercial partnerships and financing to support its growth and drug development initiatives.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has initiated the filing of a New Drug Application (NDA) for NRX-100 and plans to file for NRX-101, both targeting mental health conditions. The company has accepted non-binding terms for licensing NRX-100, potentially providing over $300 million in milestones. NRx is also acquiring precision psychiatry centers to expand its national network. They are negotiating with a strategic investor for capital to support further acquisitions. The company has regained NASDAQ compliance and reduced operating costs, forecasting profitability by the end of 2025.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced it will release its fourth quarter and full year 2024 financial results on March 17, 2025. The company will host a conference call to discuss these results and provide a corporate update. NRx is developing therapeutics based on its NMDA platform for central nervous system disorders, including suicidal bipolar depression and chronic pain. The company is working on NRX-101, an FDA-designated Breakthrough Therapy, and plans to file an NDA for Accelerated Approval. Additionally, NRx has initiated a New Drug Application for NRX-100 (IV ketamine) for suicidal depression, with Fast Track Designation from the FDA. HOPE Therapeutics, Inc. is mentioned as a partner in developing a network of interventional psychiatry clinics.

growth-positive

The article discusses the growing interest and investment in psychedelic stocks, with a focus on NRx Pharmaceuticals, Inc. The psychedelic drugs market is projected to experience significant growth, with the US market expected to expand from $4.51 billion in 2025 to $15.62 billion by 2032. This growth is driven by the therapeutic potential of psychedelics in treating various mental health disorders. Venture capital investors, such as Neo Kuma Ventures, are showing increased interest in this sector. The article highlights the potential of psilocybin and other psychedelics in treating conditions like depression and PTSD, with some drugs already receiving FDA approval for specific treatments.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, is advancing its NMDA platform for treating central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD. The company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy, and plans to file an NDA for Accelerated Approval. Additionally, NRx has initiated a New Drug Application for NRX-100 (IV ketamine) for suicidal depression, supported by clinical trials and data from French health authorities. NRx was awarded Fast Track Designation by the US FDA for ketamine development. HOPE Therapeutics, a subsidiary, aims to develop a network of interventional psychiatry clinics. The company will present updates at the Oppenheimer Healthcare Life Sciences Conference and participate in the 2025 BIO CEO & Investor Conference.

growth-positive

HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, has announced plans to expand its network of interventional psychiatry clinics. The company is focusing on combining ketamine treatment with transcranial magnetic stimulation and digital therapeutics to treat severe depression and PTSD. HOPE has engaged BTIG, a financial services firm, to provide advisory services for strategic and financing options, including identifying potential acquisition targets and facilitating acquisition capital financing. The company has secured $27 million in funding for clinic acquisition and plans to leverage this with bank debt to fund its initial rollup of clinics. This initiative aims to address the mental health crisis by establishing a global network of clinics.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has secured a financing deal consisting of $3.5 million in equity and $5.4 million in senior secured notes from institutional investors, including Anson Funds. This funding is aimed at supporting the filing of New Drug Applications for NRX-100 and NRX-101, launching HOPE Therapeutics, and potentially expanding the companys product pipeline. The financing is expected to sustain operations until 2026 and help the company achieve profitability. The investment reflects confidence in NRxs mission to develop treatments for suicidal depression and PTSD. The company plans to use the proceeds for FDA filings, launching new products, and acquiring profitable interventional psychiatry clinics.

growth-positive

HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, has secured a $25 million investment from Smith & Sauer, LLC, as part of a Series A financing round. This investment will fund the acquisition of interventional psychiatry clinics across the U.S., starting with Kadima Neuropsychiatry in La Jolla, CA. The initiative aims to create a nationwide network of clinics offering advanced treatments for severe depression and PTSD, combining ketamine, psychedelic medications, and Transcranial Magnetic Stimulation. The first tranche of $6.75 million is expected by February 7, 2025, with the full amount by April 1, 2025.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced that it has regained compliance with Nasdaqs minimum market value of listed securities requirement. This compliance was achieved after maintaining a market value of at least $35 million for 10 consecutive trading days, closing a matter that began in August 2024. NRx is developing therapeutics for central nervous system disorders, including NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression. The company plans to file a New Drug Application for NRX-100 (IV ketamine) for treating suicidal depression, having received Fast Track Designation from the FDA. The company is actively working on obtaining FDA approval for its therapies.

growth-positive

HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, Inc., is planning to acquire Kadima Neuropsychiatry Institute, with its founder, Dr. David Feifel, set to join HOPE as Chief Medical Innovation Officer. The acquisition is pending financial audits and standard closing conditions. Dr. Feifel, a leading figure in interventional psychiatry, was featured on CNN discussing the use of ketamine in psychiatric treatment. He emphasized the importance of controlled settings for such treatments. The acquisition aims to enhance HOPEs network of interventional psychiatry clinics, offering advanced therapies for depression and related disorders. This move is seen as a strategic step to expand HOPEs capabilities and reach in the mental health treatment sector.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has applied to uplist its securities to the NASDAQ Global Market. This move aims to enhance liquidity for shareholders and meet the investment requirements of institutional funds. The company is focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression and PTSD. NRx is advancing its NRX-101 and NRX-100 drugs, with the latter having received Fast Track Designation from the US FDA. The uplisting is contingent on meeting NASDAQs requirements, such as maintaining a market value above $75 million and a minimum bid price of $4.00 for 90 consecutive days.

growth-positive

HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, announced an investor workshop aimed at expanding its network of interventional psychiatry practices. The event, held at Mar-A-Lago Club, was attended by Qualified Institutional Buyers. Smith and Sauer, a private investment firm, committed $25 million to support HOPEs expansion plans, which include acquiring clinics and integrating new technologies. The company aims to expand its network by 50 clinics in 2026 and 100 clinics in 2027. The meeting was well-received, and NRx has been invited for a follow-up meeting in January 2025. The focus is on treating suicidal depression and PTSD, particularly in military and veteran communities.

growth-positive

HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, is set to expand its international network of interventional psychiatry clinics through planned acquisitions of Kadima Neuropsychiatry Institute and Dura Medical. The company has secured $27 million in anticipated funding under a binding term sheet with an institutional investor to support these acquisitions and pharmaceutical operations. The announcement coincides with the upcoming keynote address by Jonathan Javitt and Prof. David Feifel at the 8th Annual Neuroscience Innovation Forum, focusing on integrating NMDA-targeted drug therapy with other emerging modalities for treating suicidal depression and PTSD.

growth-positive

HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, Inc., announced its planned acquisition of Dura Medical, a precision psychiatry service provider in Florida. This acquisition is expected to enhance HOPEs revenue and EBITDA, serving as a cornerstone for expansion in the Southeastern States. Dura Medical, founded in 2018, offers advanced interventional psychiatry procedures and partners with the Veterans Affairs Community Cares Network to provide mental health services to veterans. Stephen Durand, founder of Dura, will join HOPE as Director of Clinic Growth for Florida. The acquisition aims to expand HOPEs services across Florida and beyond, with a mission to treat over 10,000 people by 2026.

growth-positive

NRx Pharmaceuticals and its subsidiary, HOPE Therapeutics, have announced a significant investment from Smith & Sauer, LLC. The investment includes $25 million in Series A Preferred Stock for HOPE Therapeutics, aimed at funding planned clinic acquisitions, and an additional $2 million equity investment in NRx Pharmaceuticals. This capital infusion is expected to enhance NRxs financial position and support its drug applications for NRX-100 and NRX-101. Smith & Sauer will also join the boards of both HOPE and NRx, and receive royalties on NRx product sales. The partnership aims to address mental health challenges, particularly for military and veteran communities.

growth-positive

HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, Inc., announced the acquisition of Kadima Neuropsychiatry Institute in La Jolla, CA. This acquisition is expected to enhance HOPEs international network of interventional psychiatry clinics, focusing on advanced treatments for conditions like depression, anxiety, and PTSD. Kadima is renowned for its pioneering work in CNS and psychedelic research, having introduced Ketamine Therapy at scale and serving as a lead site for major clinical trials. The acquisition is anticipated to be immediately accretive to revenue and EBITDA for NRx. Kadimas founder, Prof. David Feifel, will join HOPE as Chief Medical Innovation Officer, bringing his expertise in advanced psychiatric treatments to guide the networks growth.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced the submission of the first section of its New Drug Application (NDA) for NRX-100 (ketamine) to the FDA. The company aims to be the first to receive FDA approval for a medication treating suicidal depression. The NDA filing is expected to be completed in the first quarter of 2025. The company is expanding the indication to include Suicidal Ideation in Major Depressive Disorder, based on data from NIH- and European Government-funded trials. The FDA has requested the submission of the 1800-page manufacturing section for immediate review. NRx Pharmaceuticals plans to participate in the J.P. Morgan Healthcare Conference in January 2025.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced that its Chairman, CEO, and Chief Scientist, Dr. Jonathan Javitt, will present at NobleCon20, Noble Capital Markets Twentieth Annual Emerging Growth Equity Conference. The presentation will take place on December 3, 2024, at Florida Atlantic University. NRx Pharmaceuticals is focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression and chronic pain. The company is working on NRX-101, an FDA-designated Breakthrough Therapy, and plans to file a New Drug Application for NRX-100 (IV ketamine) for suicidal depression. The presentation will be available via webcast on the companys website and other platforms. The event highlights NRxs ongoing efforts to advance its drug development pipeline.

growth-positive

NRx Pharmaceuticals has announced the publication of a paper in the American Journal of Clinical Psychopharmacology, detailing a new methodology for training and monitoring study site raters in clinical trials. This methodology, developed during a phase 2b/3 clinical trial of NRX-101, demonstrated higher interrater reliability on the MADRS depression scale compared to industry standards. The approach allowed for statistically significant results with fewer participants, reducing costs and risks associated with higher variance in ratings. The company plans to use this methodology in future drug development and trials at its HOPE clinics, potentially accelerating the approval of new antidepressant drugs.

growth-positive

NRX Pharmaceuticals Inc (NASDAQ:NRXP) reported a significant reduction in net operating losses, achieving a 74% decrease compared to Q3 2023. The company is advancing its drug products, NRX-100 and NRX-101, with new drug application filings expected in 2024. Hope Therapeutics, a subsidiary, is anticipated to generate its first revenues by year-end. NRX Pharmaceuticals secured $5.4 million in additional financing and announced Michael Abrams as the new CFO. The company faces risks related to forward-looking statements and uncertainties in the FDA approval process for its drugs. Despite a limited cash position, NRX Pharmaceuticals is working on acquisitions and financing for Hope Clinics. The expected PDUFA dates for NRX-100 and NRX-101 are in 2025.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has appointed Michael Abrams as its permanent Chief Financial Officer. Abrams, who has extensive experience in finance and investment banking, succeeds Interim-CFO Richard Narido. The company aims to transition from a pre-revenue biotechnology firm to a profitable enterprise, focusing on developing therapeutics for central nervous system disorders. NRx is working on NRX-101, a potential non-opioid treatment for chronic pain and a therapy for suicidal bipolar depression. The appointment of Abrams is seen as a strategic move to strengthen the companys financial operations and support its growth objectives.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced its financial results and provided a business update. The company is on track to file New Drug Applications for NRX-100 and NRX-101 by the end of 2024, with a forecasted PDUFA date in 2025. HOPE Therapeutics, a subsidiary of NRx, is acquiring Interventional Psychiatry Clinics to develop a network of care for suicide prevention. The company reported a 74% reduction in net operating losses compared to the third quarter of 2023, with profitability expected in 2025. NRx secured $10.8 million in convertible-debt funding from an institutional investor to support FDA applications and retire prior debt. The acquisitions are revenue-generating and EBITDA positive, contributing to the companys growth strategy.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced the rescheduling of its third quarter and year-to-date 2024 results conference call to November 18, 2024. The company is focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression and chronic pain, using its NMDA platform. NRx is preparing to file a New Drug Application (NDA) for NRX-101, a potential non-opioid treatment for chronic pain and complicated UTI. Additionally, NRx plans to submit an NDA for NRX-100 (IV ketamine) for suicidal depression, supported by clinical trials and data from French health authorities. The company has received Fast Track Designation from the FDA for NRX-100. The article also mentions forward-looking statements regarding a proposed public offering.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced it will release its third quarter and year-to-date 2024 financial results on November 14, 2024. The company will host a conference call to discuss these results and provide a corporate update. NRx is focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression and chronic pain, using its NMDA platform. The company is working on NRX-101, an FDA-designated Breakthrough Therapy, and plans to file an NDA for its accelerated approval. Additionally, NRx is preparing to submit a New Drug Application for NRX-100 (IV ketamine) for suicidal depression. The company has been awarded Fast Track Designation by the US FDA for ketamine development. The article also mentions HOPE Therapeutics, Inc., which offers ketamine therapies for suicidal depression.

growth-positive

NRx Pharmaceuticals is set to present at the Emerging Growth Conference on October 31, 2024, highlighting its strategic move towards acquiring a national network of interventional psychiatry clinics through its HOPE Therapeutics subsidiary. The clinics focus on treating suicidal depression and PTSD using innovative therapies like ketamine and transcranial magnetic stimulation. This move aligns with NRxs strategy to expand its influence in the mental health sector, leveraging advanced treatments that target the NMDA receptor in the brain. The presentation by Dr. Jonathan C. Javitt, the companys Founder and Chairman, underscores the companys commitment to growth and innovation in the healthcare sector.

growth-positive

HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, Inc., has signed a non-binding Letter of Intent to acquire its first Interventional Psychiatry Clinics in Florida. These clinics are revenue-generating and EBITDA positive, making the acquisition immediately accretive to both revenue and EBITDA for HOPE and NRx. The acquisition is part of HOPEs strategy to establish a network of clinics offering advanced mental health treatments. The clinics will serve as a foundation for growth in Florida, and the company plans to work with the founders to optimize further acquisitions. HOPE Therapeutics aims to provide cutting-edge care for CNS healthcare providers nationwide.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, along with its subsidiary HOPE Therapeutics, Inc., will participate in the ThinkEquity Conference on October 30, 2024, in New York. The conference is a platform for institutional investors and industry professionals to explore innovations and financial strategies. Jonathan Javitt, Chairman and Chief Scientist of NRx, will present at the event, highlighting the companys developments in therapeutics for central nervous system disorders. NRx is advancing its NMDA platform, focusing on treatments for suicidal bipolar depression, chronic pain, and PTSD. The company plans to file a New Drug Application for NRX-101 and NRX-100, which have received FDA designations for accelerated approval and fast track development, respectively.

growth-negative

NRX Pharmaceuticals announced that Stephen Willard has resigned as CEO to lead a new biotech firm, with Dr. Jonathan Javitt stepping in as Interim CEO. The company is actively searching for a new CEO with expertise in commercial drug launches. During the Annual Meeting, stockholders elected Class III directors and approved the issuance of common stock, a potential reverse stock split, and the appointment of Salberg & Company, P.A. as independent auditors. These actions are part of NRX Pharmaceuticals efforts to strengthen governance and strategically navigate the pharmaceutical industry.

growth-positive

HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, Inc., has signed a non-binding Letter of Intent to acquire a leading West Coast Interventional Psychiatric Clinic. This acquisition aims to establish a prototype for HOPEs network of clinics, providing advanced treatments for CNS disorders such as suicidal depression and PTSD. The founder of the clinic will join HOPE as Chief Medical Innovation Officer, enhancing the companys standard of care. This move is expected to be immediately accretive to HOPEs revenue and EBITDA. The acquisition aligns with HOPEs strategy to expand its clinic network and offer cutting-edge treatments, including ketamine and other therapies, to patients nationwide.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced the completion of a twelve-month real-time stability study on the first manufactured lot of NRX-100 (Ketamine) at Nephron Pharmaceuticals. This milestone supports the submission of a New Drug Application (NDA) to the FDA for the use of intravenous ketamine to treat suicidal depression. The stability findings indicate that the preservative-free formulation of NRX-100 has a projected room temperature shelf stability of over three years. The company plans to file the NDA in 2024. This development is significant as FDA approval is typically required for insurance reimbursement, and the new formulation aims to avoid toxic side effects associated with current preparations.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has been featured in an article on Psychiatrist.com, highlighting its promising new treatments for bipolar depression and suicidal ideation. The company is developing NRX-100, a preservative-free formulation of IV ketamine, and NRX-101, a combination of D-cycloserine and lurasidone, both showing higher efficacy in treating suicidal crises and treatment-resistant bipolar depression. NRx plans to file a New Drug Application for both treatments, aiming for accelerated approval. The company has received Fast Track Designation from the FDA for NRX-100. This development is expected to positively impact the companys growth by attracting new customers and enhancing its market position.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, and its subsidiary HOPE Therapeutics, Inc. announced their participation in the H.C. Wainwright 26th Annual Global Investment Conference, scheduled for September 9-11, 2024. The event will take place both virtually and in-person at the Lotte New York Palace Hotel in New York City. Jonathan Javitt, Chairman and Chief Scientist of NRx, will present an overview of the companys business, focusing on their NMDA platform and investigational therapies for central nervous system disorders. The conference aims to attract institutional investors and provide insights into NRxs ongoing and future projects.

growth-positive

HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, Inc., announced a non-binding term sheet for $30 million in non-dilutive financing to acquire its first interventional psychiatry clinics. The company has also signed a term sheet for five operational clinics in the Western U.S., generating over $10 million in annual revenue. HOPE projects annualized revenues of $100 million through continued acquisitions by mid-2025. The company aims to create a unified network of clinics offering treatments for suicidal depression, TRD, and PTSD. Additional information will be presented at the HC Wainwright Annual Global Investment Conference in September 2024.

growth-positive

NRx Pharmaceuticals, Inc. has secured $10.8 - $16.3 million in convertible-debt funding from Anson Funds. The funding is targeted to support FDA New Drug Applications for NRX-100 (ketamine) and NRX-101. The company also announced the completion of the audit of HOPE Therapeutics and plans to file a New Drug Application (NDA) for Accelerated Approval under Breakthrough Therapy Designation and Priority Review of NRX-101 in the treatment of bipolar depression. Additionally, the company appointed Dr. Dennis McBride to its Board of Directors and plans to host a conference call on August 14, 2024.

growth-positive

NRx Pharmaceuticals, Inc. has secured up to $16 million in convertible debt financing from Anson Funds. The funds will be used to support the 2024 New Drug Application filing for its two lead products, NRX-100 and NRX-101, and to retire existing debt from Streeterville Capital. The interest rate and other costs of capital are substantially lower than prior debt. The Notes have an interest rate of 6% per annum with a term of 15 months and will be convertible into shares of the Companys common stock.

Growth-Positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has announced that it will release its second quarter and year to date 2024 financial results on August 14, 2024. The company will also host a conference call to discuss the financial results and provide a corporate update. NRx is developing therapeutics for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The company has plans to submit a New Drug Application for NRX-100 for the treatment of suicidal depression.

Growth-Positive

NRx Pharmaceuticals has announced a communication from the US Food and Drug Administration (FDA) providing feedback and alignment on NRxs proposed initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in the treatment of suicidal depression. The company remains on track to file the New Drug Application (NDA) for NRX-100 in Q4 2024. Based on the guidance received, NRx and HOPE Therapeutics will commit to conducting a clinical trial of NRX-100 in adolescents aged 9-17 with suicidal depression. The company is also developing NRX-101 for the treatment of suicidal bipolar depression, chronic pain, and PTSD.

growth-positive

NRx Pharmaceuticals, Inc. has posted a new Shareholder Update Letter on its website outlining potential paths to profitability by 2025. The company expects revenue from the operation of HOPE Therapeutics-branded interventional psychiatry clinics in 2024 and from sales of NRX-100 and NRX-101 in 2025, pending FDA approval. NRx is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain, in partnership with Alvogen and Lotus. The company also plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression.

growth-positive

NRx Pharmaceuticals, Inc., a clinical-stage pharmaceutical company, has announced that its management will participate in the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference on June 27, 2024. The companys Chairman and Chief Scientist, Dr. Jonathan Javitt, and Chief Business Officer, Matthew Duffy, will hold one-on-one meetings with investors throughout the day. The company is developing NRX-101, a drug for the treatment of central nervous system disorders, in partnership with Alvogen and Lotus. NRx also plans to submit a New Drug Application for HTX-100 (IV ketamine) for the treatment of suicidal depression.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced the addition of Dr. Dennis McBride to its Board of Directors. Dr. McBride brings extensive experience in neuroscience, medical and information technology, and digital therapeutics. He has led numerous national and international initiatives in neuroscience and its interface with information technology, national security, and medical technology/drug development. He has also participated with NRx founders in developing digital therapeutic technology for the reduction of stress and depression.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced progress in the development of its ketamine formulation (NRX-100) for treating severe depression and suicidality. The company has reached a 9-month stability point with NRX-100 and initiated three manufacturing lots for future drug release. The FDA has highlighted the need for nonclinical safety data for intravenous ketamine as a condition of approval. NRx has also announced plans to submit a New Drug Application for NRX-100 in 2024, based on well-controlled clinical trials and newly obtained data from French health authorities.

growth-positive

NRx Pharmaceuticals, Inc. has announced the presentation of its Phase 2b/3 trial of NRX-101, a drug for adults with bipolar depression and subacute suicidal ideation or behavior. The trial demonstrated that NRX-101 has a similar antidepressant effect to lurasidone, the standard care drug, but with a 58% relative reduction in time to sustained remission from suicidality and a 76% reduction in symptoms of akathisia, a side effect linked to suicide. The company believes that NRX-101 has the potential to become a standard of care drug for treating bipolar depression.

growth-positive

NRx Pharmaceuticals, Inc. has reported positive data from a Phase 2b/3 trial of NRX-101 in Treatment Resistant Bipolar Depression. The company plans to file a New Drug Application (NDA) for Accelerated Approval under Breakthrough Therapy and Priority Review of NRX-101. The company has also developed a patentable pH neutral formulation for ketamine. HOPE Therapeutics, a subsidiary of NRx, has partnered with representatives of ketamine clinic providers nationwide to construct a care platform. The company has also executed a term sheet from an institutional investor for an initial $7.5 million note, primarily to replace current debt.

growth-positive

NRx Pharmaceuticals, Inc. is making significant strides in the development of therapeutics for central nervous system disorders. The company is developing NRX-101, a treatment for suicidal bipolar depression and chronic pain, in partnership with Alvogen Pharmaceuticals. NRx has announced plans to submit a New Drug Application for NRX-100, a treatment for suicidal depression. The company has also developed a proprietary formulation of IV Ketamine, HTX-100, in partnership with Nephron Pharmaceuticals. NRx has also announced successful results from a clinical trial of NRX-101 and is poised to receive $320 million in further milestones along with mid-teen royalties on Net Sales.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced its participation in the EF Hutton Annual Global Conference on May 15, 2024. The companys Chairman and Chief Scientist, Prof. Jonathan Javitt, and Chief Business Officer, Matthew Duffy, will hold one-on-one meetings with investors. NRx is developing therapeutics for central nervous system disorders and has partnered with Alvogen and Lotus for the development and marketing of NRX-101, a treatment for suicidal bipolar depression. The company also plans to submit a New Drug Application for HTX-100 (IV ketamine) for the treatment of suicidal depression.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced that it will release its Q1 2024 financial results on May 14, 2024. The company will also host a conference call to discuss the financial results and provide a corporate update. NRx is developing therapeutics for the treatment of central nervous system disorders and has partnered with Alvogen and Lotus for the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. The company has also announced plans to submit a New Drug Application for HTX-100 (IV ketamine) for the treatment of suicidal depression.

growth-positive

NRx Pharmaceuticals has announced a significant safety advantage of its drug NRX-101 over the standard of care comparator in its recently completed clinical trial in patients with suicidal bipolar depression. The company plans to seek accelerated FDA approval for NRX-101 for use in patients with bipolar depression at risk of akathisia. The full clinical trial results will be presented at the upcoming meeting to the American Society of Clinical Psychopharmacology held May 28-31, 2024 in Miami. The company believes that the demonstration of reduced akathisia in the setting of comparable antidepressant efficacy constitutes a basis for Accelerated FDA Approval of NRX-101.

growth-positive

NRx Pharmaceuticals has announced promising results from its phase 2b/3 clinical trial of NRX-101 vs lurasidone for the treatment of suicidal bipolar depression. The trial demonstrated a 33% reduction in suicidality and a 70% reduction in symptoms of akathisia, a side effect of antidepressants linked to suicide. The company believes that NRX-101 has the potential to become the standard of care for treatment of bipolar depression. The trial was a randomized, prospective, double-blind study conducted at multiple sites in the United States.

growth-positive

NRx Pharmaceuticals, Inc. has announced the pricing of its underwritten public offering of shares at $3.30 per share, aiming to raise approximately $2.0 million. The company has also granted the underwriters a 45-day option to purchase up to an additional 91,050 shares. The offering is expected to close on April 19, 2024. The net proceeds from the offering will be used for working capital and general corporate purposes, including initiating a national treatment protocol and safety database, and potentially to repay certain outstanding debt.

Growth-Positive

NRx Pharmaceuticals, Inc. has received confirmation from Nasdaq that they have demonstrated compliance with the Nasdaq bid price requirement in Listing Rule 5550(a)(2) and will continue to be listed on The Nasdaq Stock Market. The company is now in a position to reach four important milestones including data from trials in Suicidal Bipolar Depression and Chronic Pain, NDA filing for IV Ketamine, and distribution of shares of HOPE Therapeutics to existing shareholders. The company is developing therapeutics for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD.

growth-positive

NRx Pharmaceuticals has announced new data showing that its drug, NRX-101, does not damage intestinal or vaginal flora, unlike other antibiotics used to treat complicated urinary tract infections (cUTI). The drug has received FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for cUTI and Pyelonephritis. The company believes that if the data is replicated in patients, NRX-101 could be the first antibiotic for cUTI and pyelonephritis that has no risk of causing C. diff infection or vaginal yeast infection. The drug could potentially change the lives of the half million Americans each year who contract C. diff and save lives among the tens of thousands who die from antibiotic-induced C. diff infections.

growth-positive

NRx Pharmaceuticals, Inc. has announced its intention to sell shares of its common stock in an underwritten public offering. The company plans to use the net proceeds from the offering for working capital and general corporate purposes, including initiating a national treatment protocol and safety database. The offering is subject to market conditions and there is no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. EF Hutton LLC is acting as the sole book-running manager for the offering.

growth-positive

NRx Pharmaceuticals has developed a novel, proprietary formulation of IV Ketamine for use as HTX-100. This new formulation has the key advantage of achieving neutral pH, in contrast to the acidic pH of generic formulations of ketamine. This patentable invention may enable the administration of ketamine in insulin pump-like devices in the clinic setting. The company has previously executed a joint development agreement with a manufacturer of insulin pumps. The new formulation was developed with partner Nephron Pharmaceuticals, a leading sterile products manufacturer. HTX-100 is expected to be marketed by HOPE Therapeutics, Inc., a wholly owned subsidiary of NRx.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced that it has achieved data-lock in its Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study with NRX-101. With positive data from this study and FDA comment, NRx becomes eligible to receive the balance of its first milestone (an additional $4 million) from partners Alvogen, Inc. and Lotus Pharmaceuticals, Inc. These partners would then be responsible for all future development costs in this indication. NRx retains rights for all other indications, including chronic pain and PTSD. NRx is then poised to receive $320 million in further milestones along with mid-teen royalties on Net Sales.

growth-positive

NRx Pharmaceuticals, Inc. has reported its financial results for the quarter and year ended December 31, 2023, and provided a business update. The company has reduced its corporate overhead by 50% and overall net loss by 25% in 2023 compared to 2024. The company forecasts its first commercial revenue in 2024 from sales of ketamine and related technologies. The company has also announced a new partnership around the first drug to potentially modify the underlying cause of schizophrenia. The company has received advance of first milestone payments in 2024 for ongoing development of NRX-101 from Alvogen and Lotus Pharmaceuticals, Inc.

growth-positive

NRx Pharmaceuticals, Inc. announces its anticipated financial results for the quarter and year ended December 31, 2023. The company has improved its negative Earnings per Share to ($0.40) in FY 2023 vs ($0.60) in the prior 12 month period. It raised $9.2 million in new capital during FY 2023 with $7.8 million of additions to working capital during Q1 2024. NRx Pharmaceuticals signed a development partnership with Alvogen, Inc., and Lotus Pharmaceuticals, Inc. The company also completed enrollment and last patient visit of the Phase 2b/3 trial of NRX-101 in Suicidal Bipolar Depression. The company expects to file a New Drug Application for treatment of Acute Suicidality by June 2024.

Growth-Positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced its intention to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 10 pre-split shares. The reverse stock split will become effective at 4:30 p.m. Eastern Time on Monday, April 1, 2024. The Companys common stock will continue to be traded on the Nasdaq Capital Market under the symbol NRXP and will begin trading on a split-adjusted basis when the market opens on Tuesday, April 2, 2024. The reverse stock split will reduce the number of shares of the Companys common stock outstanding from 95,699,780 shares to approximately 9,569,978 shares.

Neutral

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced that it will release its fourth quarter and full year 2023 financial results on March 28, 2024. The company will also provide a corporate update via a conference call on April 1, 2024. NRx is developing therapeutics for central nervous system disorders and has partnered with Alvogen and Lotus for the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. The company also plans to submit a New Drug Application for HTX-100 (IV ketamine) for the treatment of suicidal depression.

Growth-Positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced that Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx Pharmaceuticals and co-CEO of HOPE Therapeutics, will present at the Ketamine 2024 Conference. The conference is a gathering of top scientists and clinicians in the field of Ketamine and related compounds for affective disorders. Dr. Javitt will present a keynote talk on the efficacy of Ketamine in the treatment of acute suicidality and the potential risks associated with its long-term use. NRx Pharmaceuticals is developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced that it will release its Q4 and full year 2023 financial results on March 28, 2024. The company will also provide a corporate update during a conference call on the same day. NRx is developing therapeutics for the treatment of central nervous system disorders and has partnered with Alvogen and Lotus for the development and marketing of NRX-101, a treatment for suicidal bipolar depression. The company also plans to submit a New Drug Application for HTX-100 (IV ketamine) for the treatment of suicidal depression.

Growth-Positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced the results of a vote held during a special meeting of shareholders. The meeting was called to vote on a proposal to effect a reverse stock split of all outstanding shares of NRx common stock at a ratio to be determined by the Board. Despite attempts to suppress the vote, 61.4% of all eligible shares were voted, with 94.4% of votes cast in favor of the proposal. The company is developing therapeutics for the treatment of central nervous system disorders and has partnered with Alvogen and Lotus for the development and marketing of NRX-101.

growth-positive

NRx Pharmaceuticals Board of Directors has authorized a Dividend of HOPE Therapeutics stock and a royalty right of 1% of Ketamine sales to NRXP Shareholders and applicable warrant holders. The intent is to distribute 49% of HOPE stock in this dividend. HOPE Therapeutics was recently formed to advance HTX-100 (IV Ketamine) to a New Drug Application filing and subsequent commercialization in the near term. Shares of HOPE are planned to be publicly listed. The dividend is seen as a step to building value for all of the Companys stakeholders.

growth-positive

NRx Pharmaceuticals, Inc. has initiated actions to combat short sellers in the companys stock. The company is considering a reverse split to maintain NASDAQ listing compliance, which would be accompanied by a change in corporate name and CUSIP number. The company has also retained former SEC enforcement leadership to notify leading brokerages of the need to close all naked short positions in the companys securities and to prevent future accumulation of naked short positions in the companys new security. The company is developing therapeutics for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD.

growth-positive

NRx Pharmaceuticals and its subsidiary HOPE Therapeutics have completed a Memorandum of Understanding with Conversio Health and Nephron Pharmaceuticals to provide IV Ketamine to patients and clinics across the US. The company has also entered into a business relationship with an organization serving over 100 ketamine clinics nationwide. The initial stock of ketamine for sale is expected by the end of March 2024. The company is also planning to file a New Drug Application with the FDA in the coming months for the potential launch of HTX-100 in early 2025.

growth-positive

NRx Pharmaceuticals has announced the completion of its Phase 2b/3 study of NRX-101, a potential treatment for Suicidal Treatment Resistant Bipolar Depression. The studys completion marks a significant step in the development of the drug, which could be the first of its kind to be approved. Positive data from the trial would trigger a $4 million milestone payment from partners Alvogen and Lotus, who would then assume development costs. The agreement could provide up to $329 million in milestone payments and a royalty on net sales. Top-line data from the study is expected to be released soon.

growth-positive

Insiders at NRx Pharmaceuticals, Inc. have been buying shares over the past year, which is generally a positive sign for the companys shareholders. The largest single purchase was made by Co-Founder Jonathan Javitt, who bought US$64k worth of shares at a price of US$0.32 per share, significantly below the recent price of US$0.44. Overall, insiders at NRx Pharmaceuticals own about US$6.8m worth of shares, equating to 21% of the company. Despite there being no insider transactions in the last three months, the overall trend suggests that insiders are not doubting the company.

Growth-Positive

NRx Pharmaceuticals has received an investment of approximately $1.0 million from an existing investor. The shares were sold at a 26.7% premium to the recent share offering. The investment will help the company achieve milestones across its development pipeline, including Suicidal Depression, Suicidal Bipolar Depression, and Chronic Pain data. The company is also planning to launch Hope Therapeutics and is expecting data from two important clinical trials in the coming months. The shares and warrants subscribed are not currently registered and may only be purchased by accredited investors.

Growth-Positive

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has announced the pricing of its underwritten public offering of shares of its common stock at a public offering price of $0.30 per share, for aggregate gross proceeds of approximately $1,500,000. The company has also granted the underwriters a 45-day option to purchase up to an additional 750,000 shares of common stock at the public offering price per share. The offering is expected to close on February 28, 2024. The net proceeds from the offering will be used for working capital and general corporate purposes, and to service current debt obligations.

growth-positive

NRx Pharmaceuticals, Inc. has announced plans to award 50% of founding shares in HOPE Therapeutics to current shareholders, subject to board approval. The company also anticipates having manufactured ketamine supplies for shipment by July 1, 2024. Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx Pharmaceuticals, will present a corporate overview at the BIO CEO & Investor Conference in February 2024. The company is also in the process of completing a Memorandum of Understanding to begin sales of IV ketamine to qualified clinics in partnership with a holder of a nationwide pharmacy license.

growth-positive

NRx Pharmaceuticals, Inc. has announced its intention to sell shares of its common stock in an underwritten public offering. The company plans to use the net proceeds from the offering for working capital and general corporate purposes, and potentially to repay certain outstanding debt. EF Hutton LLC is acting as the sole book-running manager for the offering. The offering is subject to market conditions and there is no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

growth-positive

NRx Pharmaceuticals has announced plans to launch HOPE Therapeutics, a subsidiary focused on the development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression. The company has completed the initial manufacture of Ketamine and plans to file an FDA New Drug Application upon demonstration of 2-year shelf stability, expected in Q2 2024. HOPE also plans to initiate a 506(c) pre-IPO offering of pre-IPO shares for qualified investors. The companys Chairman and Chief Scientist, Dr. Jonathan Javitt, will present a corporate overview at the BIO CEO & Investor Conference in February 2024.

growth-positive

NRx Pharmaceuticals, Inc. has announced the advance of the first $5 million milestone payment based on the Companys partnership agreement with Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. The payment will be used to fund the development of NRX-101 through the phase 2 meeting with FDA. In return, Alvogen and Lotus will receive 4.1 million warrants to purchase the Companys common stock. NRx remains eligible for an additional $320 million in future development and sales milestones, as well as royalty payments on Net Sales.

growth-positive

NRx Pharmaceuticals, Inc. has completed enrollment for its phase 2b/3 trial of NRX-101, a treatment for suicidal treatment-resistant bipolar depression. The trials readout is expected in Q2 of this year. The companys Asia Pacific strategic partner, Lotus Pharmaceutical Co. Ltd, identified this as a significant event. Lotus provides the Asia Pacific component of NRxs global partnership with Alvogen, Inc. NRx is developing therapeutics for central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The company plans to submit a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression.

growth-positive

NRx Pharmaceuticals has announced the incorporation of HOPE Therapeutics, a biotech company dedicated to bringing NRX-100 (IV Ketamine) for Suicidal Depression. HOPE Therapeutics will initially be owned by NRx and its current shareholders, who will receive their shares in the form of a dividend. The company also plans to file a New Drug Application for NRX-100 in the first half of 2024. Furthermore, NRx is initiating actions to gain a public listing and has attracted a $30 million investment commitment upon HOPEs planned public listing.

growth-positive

NRx Pharmaceuticals has completed enrollment for its Phase 2b/3 study of NRX-101, a treatment for suicidal treatment-resistant bipolar depression. The enrollment of 74 patients exceeded the original target of 70. Positive data from this trial will trigger a milestone payment from Alvogen, who will then be responsible for further development and commercialization costs. NRX-101 is the first and only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression. Top-line results from the trial are expected later this quarter.

growth-positive

NRx Pharmaceuticals, Inc. has announced that the Nasdaq Hearings Panel has granted the companys request to transfer its listing to The Nasdaq Capital Market, subject to the company meeting all applicable criteria for continued listing on the Capital Market tier. The company is working to evidence compliance with the minimum bid price requirement by April 16, 2024. NRx Pharmaceuticals is also planning to submit a New Drug Application for ketamine in the treatment of suicidal depression. The company has partnered with Alvogen Pharmaceuticals for the development and marketing of NRX-101 for the treatment of suicidal bipolar depression.

growth-positive

NRx Pharmaceuticals has received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the US FDA for NRX-101, a treatment for complicated urinary tract infections (cUTI) and pyelonephritis. The QIDP designation grants Priority Review and an additional 5 years of product exclusivity. The FDA also granted NRX-101 Fast Track designation for cUTI, allowing for rolling submission of the Companys New Drug Application. The company is seeking partners for commercialization of NRX-101.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced plans to file a New Drug Application for Ketamine to treat suicidal depression in 2024, both in the United States and the European Union. The company has partnered with Nephron Pharmaceuticals to develop a modern, single-use, diversion- and tamper-resistant formulation of ketamine. NRx has also partnered with Alvogen Pharmaceuticals for the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. The company has incorporated HOPE Therapeutics, Inc. to carry forward its drug development of ketamine and will be awarding rights in HOPE to existing shareholders together with new investors.

growth-positive

NRx Pharmaceuticals has announced plans to achieve compliance with Nasdaq market requirements related to minimum bid price and total Market Value of Listed Securities (MVLS). The company has requested to move its listing to the Nasdaq Capital Market, where the MVLS is set at $35 million. NRx has demonstrated compliance with this requirement since December 18, 2023. The company will present its compliance plan to Nasdaq on January 4, 2024. The plan is based on achieving clinical and regulatory milestones. NRx has four near-term drug approval opportunities and has partnered with Alvogen for $330 million in potential milestones.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced the election of Janet Rehnquist to its Board of Directors. Rehnquist, an experienced healthcare lawyer and former Inspector General of the US Department of Health and Human Services, will chair the compliance and the nominating committees. The company is developing therapeutics for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. It has recently announced plans to submit a New Drug Application for ketamine in the treatment of suicidal depression.

growth-positive

NRx Pharmaceuticals, Inc. has signed a License Data and Technical Information Agreement with Columbia University for rights to data from a trial of 80 patients hospitalized for Acute Suicidality in Depression. This is the second trial supporting the use of IV Ketamine in suicidal depression. The company plans to present the data from these trials to the FDA in support of a New Drug Application to be filed in Q1 2024. The company has also partnered with Nephron Pharmaceuticals for manufacturing and stability data. The company is also developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain.

Growth-Positive

NRx Pharmaceuticals, Inc. has received clearance from the US FDA for its Investigational New Drug Application (IND) for the use of NRX-101, a patented combination of D-cycloserine and lurasidone, for the treatment of complicated Urinary Tract infections (cUTI). The company plans to spin out a new company dedicated to the development and commercialization of NRX-101 for cUTI. The company has recruited Michael Manyak, MD, as Lead Clinical Advisor for this initiative. The company is also awaiting the FDAs response to its request for Qualified Infectious Disease Product (QIDP) designation.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced its 2023 Annual Meeting of Stockholders to be held on December 19, 2023. The meeting will discuss the election of Janet Rehnquist to the Companys Board of Directors and the planned spinoff of Hope Therapeutics, Inc. NRx is developing therapeutics for the treatment of central nervous system disorders and has partnered with Alvogen Pharmaceuticals for the development and marketing of NRX-101, a treatment for suicidal bipolar depression and chronic pain. The company also plans to submit a New Drug Application for ketamine in the treatment of suicidal depression.

Growth-Positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced its participation in the LifeSci Partners Corporate Access Event from January 8th through the 10th in San Francisco. The company is expected to discuss its recent progress, upcoming clinical and regulatory catalysts, and answer questions. It has four near-term shots on goal with commercial and/or monetization opportunities. These include NRX-100, a potential ketamine product for bipolar and unipolar depression, and NRX-101 for treatment-resistant bipolar depression, chronic pain, and complicated urinary tract infection. The company has partnered with Alvogen for the development and marketing of NRX-101.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that its Founder and Chief Scientist, Dr. Jonathan Javitt, will present a corporate overview at the Noble Capital Markets 19th Annual Emerging Growth Investor Conference on December 4th, 2023. The company is developing therapeutics for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRx has partnered with Alvogen Pharmaceuticals for the development and marketing of NRX-101, a treatment for suicidal bipolar depression. The company also plans to submit a New Drug Application for ketamine in the treatment of suicidal depression.

Growth-Positive

NRx Pharmaceuticals is making significant progress in developing treatments for suicidal ideation and depression. The company is focusing on the NMDA receptor in the brain, which is crucial for turning off suicidal thoughts. Traditional antidepressants often increase suicide risk, emphasizing the need for a new approach. The company is nearing its clinical trial enrollment goals for its partnered product NRX-101, while also launching new clinical initiatives in chronic pain, urinary tract infection, and NRX-100 for suicidal depression. The trial is nearing completion of enrollment of the originally-targeted 70 participants in the Phase 2b/3 trial of NRX-101.

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NRx Pharmaceuticals, Inc. has announced its financial results for the quarter ended September 30, 2023, and provided a business update. The company is nearing completion of enrollment for the Phase 2b/3 trial of NRX-101 in Treatment Resistant Bipolar Depression. It has also opened the Investigational New Drug application with the FDA to treat chronic pain with NRX-101 and complicated Urinary Tract Infection. The company is planning a newly capitalized, publicly traded, ketamine-focused entity that will be owned by NRx, current NRx shareholders, and new investors. The company also plans to address evidence of naked shorting of NRx securities.

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NRx Pharmaceuticals, a late-stage biopharmaceutical company, will release its third quarter 2023 financial results on November 14, 2023. The company will also provide a corporate update and discuss the financial results in a conference call. The update is expected to include progress on the development of NRX-101 for the treatment of bipolar depression, chronic pain, UTI and other indications, as well as plans for NRX-100 (ketamine) development. NRx has partnered with Alvogen Pharmaceuticals for the development and marketing of NRX-101.

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NRx Pharmaceuticals and Nephron Pharmaceuticals have announced a partnership to develop and manufacture a formulation of ketamine for treating suicidal depression. The partners aim to submit a New Drug Application by March 1, 2024, and target a finished drug with two-year shelf stability for November 2024, pending FDA approval. The drug is intended to address the urgent public health need for more effective treatments for suicidal depression, a condition affecting more than 3 million Americans. The partnership will leverage Nephrons manufacturing expertise and NRxs clinical trial data.

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NRx Pharmaceuticals, Inc. has announced the signing of a development contract to manufacture a presentation of ketamine suitable for intravenous administration under current FDA manufacturing regulations. The company aims to file a New Drug Application for Ketamine in 2024. Existing supplies of Ketamine are not labeled for treatment of depression and suicidality and often do not conform to modern manufacturing requirements for single-dose injectable medications. The company and its manufacturing partner plan to release further information in an upcoming 8K filing.

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NRx Pharmaceuticals, Inc. has received a Study May Proceed letter from the FDA, allowing the company to continue with a pharmacokinetic study for the treatment of Chronic Pain. The preclinical requirements identified by the FDA are consistent with the already-implemented requirements for the use of NRX-101 to treat Bipolar Depression. The company is now awaiting results from a DOD-funded trial of D-cycloserine vs. placebo to confirm the previously-identified efficacy signal and dosing range.

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NRx Pharmaceuticals, Inc. has announced a strategic acceleration of its plans to develop a commercial form of NRX-100 (intravenous ketamine) to treat acute depression and suicidality. This decision is based on recent data cooperation agreements and changes in the regulatory environment. The company has signed a Data Sharing Agreement to gain access to patient level data from a major Ketamine study in France. The findings of this trial demonstrate a dramatic effect of intravenous ketamine in reducing acute suicidality and depression, particularly in patients with bipolar depression. The company is also developing NRX-101, a fixed dose combination of D-cycloserine and lurasidone, for the treatment of suicidal treatment-resistant bipolar depression.

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NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that its Chief Scientist, Dr. Jonathan Javitt, will present a corporate overview at the 8th Annual Dawson James Conference on October 12th, 2023. The company is developing therapeutics for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. Its lead program, NRX-101, targets the brains NMDA receptor and is being investigated in a Phase 2b/3 clinical trial for suicidal treatment-resistant bipolar depression. The company has partnered with Alvogen Pharmaceuticals, who owns the worldwide rights to NRX-101.

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NRx Pharmaceuticals has received clearance from the FDA to proceed with human trials for its drug, NRX-101, to treat chronic pain. The company plans to seek Fast Track and Breakthrough Therapy Designations from the FDA while awaiting the results of a Dept of Defense-funded trial. The drug is based on D-cycloserine, a key ingredient of NRX-101, and the company recently licensed a US Patent for its use in the treatment of pain. The company also announced the expansion of its NRX-101 program to include the treatment of chronic pain.

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Dawson James Securities, Inc. announces its 8th Annual Dawson James Small Cap Growth Conference on October 12, 2023. The conference brings together senior leadership from over 30 innovative companies in healthcare, technology, and consumer sectors. Attendees include top institutional funds, prestigious family offices, and high-net-worth investors. The event offers a chance to connect corporate leaders with growth capital and broader markets. It also provides a platform for one-on-one meetings with presenting company executives, potentially paving the way for long-lasting partnerships.

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NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has announced a new Shareholder Update Letter on its website. The update highlights the implications of the companys recent Data Sharing Agreement to gain access to patient-level data from a major Ketamine study in France. The companys lead program, NRX-101, is being investigated in a Phase 2b/3 clinical trial for suicidal treatment-resistant bipolar depression. The company has partnered with Alvogen Pharmaceuticals, who owns the worldwide rights to NRX-101 for treatment of S-TRBD.

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Sidoti Events, LLC, an affiliate of Sidoti & Company, LLC, has announced the schedule for its two-day September Small-Cap Conference taking place on September 20-21, 2023. The conference will feature presentations from a wide range of small-cap companies, providing a platform for meaningful interaction between small and microcap issuers and investors specifically interested in companies in the sector. Sidoti Events, LLC was formed in 2023 to focus on the companys growing conference business and to serve the needs of presenters and attendees more directly.

Growth-Positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that its CEO, Stephen Willard, and Chief Scientist, Dr. Jonathan Javitt, will present a company overview at the Sidoti Virtual Small Cap Conference on September 21, 2023. The companys lead program, NRX-101, a treatment for suicidal bipolar depression, chronic pain, and PTSD, is currently in late-stage clinical trials. NRx has partnered with Alvogen Pharmaceuticals, who owns the worldwide rights to NRX-101 for treatment of suicidal treatment-resistant bipolar depression.

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NRx Pharmaceuticals has signed a data sharing agreement with the leadership of a clinical trial conducted in 7 French Government Hospitals. The trial demonstrated a significant reduction in suicidal ideation and depression among patients treated with intravenous racemic ketamine. The company plans to present the data to the FDA with the aim of identifying a path to a New Drug Application (NDA). The company has also partnered with Alvogen Pharmaceuticals, who owns the worldwide rights to NRx-101 for treatment of Suicidal Treatment-Resistant Bipolar Depression (S-TRBD).

Growth-Positive

NRx Pharmaceuticals, Inc. has announced a partnership with LS Associates, a division of LifeSci Advisors, LLC, to provide financial consulting services. As part of the agreement, Richard Narido, a veteran in the industry, has been appointed as the Interim Chief Financial Officer of NRx Pharmaceuticals. Prior to this, Narido served as the CFO of Lucira Health until its acquisition by Pfizer Inc. in April 2023. The company also announced the resignation of its former CFO, Seth Van Voorhees, effective from September 30, 2023.

growth-positive

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that its CEO, Stephen Willard, and Chief Scientist, Dr. Jonathan Javitt, will present a company overview at the H.C. Wainwright 25th Annual Global Investment Conference on September 12, 2023. The presentation will include information about NRX-101, a treatment for suicidal bipolar depression, chronic pain, and PTSD. The company has partnered with Alvogen Pharmaceuticals, who owns the worldwide rights to NRX-101 for treatment of S-TRBD.

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NRx Pharmaceuticals has announced new data showing the potent antibacterial effect of NRX-101 against antibiotic-resistant urinary tract infections (cUTIs). The drug, a combination of D-cycloserine and lurasidone, was originally developed in the 1950s but was replaced by antibiotics that have since lost effectiveness against cUTIs. The company is now seeking to develop NRX-101 as a treatment for cUTIs, suicidal depression, and chronic pain. The drug has already been granted Fast Track Designation, Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support from the FDA for S-TRBD.

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NRx Pharmaceuticals has submitted an Investigational New Drug (IND) application to the FDA for the use of NRX-101 to treat Chronic Pain. The application is supported by robust manufacturing, pre-clinical, and clinical data. NRX-101 targets the NMDA receptor in the brain and has already been granted Breakthrough Therapy Designation for the treatment of suicidal Bipolar Depression. The company plans to seek Fast Track Designation, Priority Review, and Breakthrough Therapy Designation for the use of NRX-101 in Chronic Pain. NRx Pharmaceuticals has completed critical manufacturing components required by the FDA and has sufficient quantities of the investigational drug on hand to launch registrational studies in 2024. Chronic pain is estimated to be a $72 billion industry today with the potential to grow to a $120 billion industry by 2033.

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NRx Pharmaceuticals has received $1.2 million in cash from existing investors through the sale of preferred shares. The funds will be used for the development of NRX-101 in Suicidal Bipolar Depression and Chronic Pain, as well as for general corporate purposes. The purchase agreement allows the preferred shares to convert into common shares and warrants after six months. NRx Pharmaceuticals aims to release data from two important clinical trials during this period. NRX-101, a fixed dose combination of D-cycloserine and lurasidone, has received Fast Track Designation, Breakthrough Therapy Designation, and other support from the FDA for the treatment of Bipolar Depression with Suicidality. It is also being developed for chronic pain and PTSD.

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NRx Pharmaceuticals Co-Founder, Jonathan Javitt, recently purchased $64k worth of stock, increasing their shareholding by 1.4%. This insider transaction is seen as a positive sign. Over the past year, insiders have bought more shares than they sold, with an average buy price of $0.81. NRx Pharmaceuticals insiders own 23% of the company. However, the company is making losses and has several warning signs. The article provides general stock analysis and is not financial advice.

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NRx Pharmaceuticals, Inc. has announced its financial results for the second quarter of 2023 and provided a business update. The company has entered into a collaboration with Alvogen Pharmaceuticals and Lotus Pharmaceuticals for the global development and commercialization of NRX-101 in suicidal bipolar depression. The company is also planning to develop NRX-101 for chronic pain indications and has filed an Investigational New Drug application with the FDA to treat chronic pain with NRX-101. The company closed a $6.28 million registered direct offering with H.C. Wainwright in June 2023. The company recorded $3.9 million of research and development expenses and $4.1 million of general and administrative expenses for the three months ended June 30, 2023.

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NRx Pharmaceuticals has licensed US Patent 8,653,120 for the use of D-Cycloserine in treating chronic pain. The company has also signed an agreement with Dr. Vania Apkarian, a leading researcher in pain and D-Cycloserine, to join the NRx Scientific Advisory Board. The company is making significant progress in developing NRX-101, a drug for chronic pain treatment. The patent is supported by extensive nonclinical data and early clinical data that suggest the potential for NMDA antagonist drugs, such as NRX-101, to decrease both chronic pain and neuropathic pain while potentially decreasing craving for opioids.

growth-positive

NRx Pharmaceuticals, a late-stage biopharmaceutical company, has announced that it will release its Q2 2023 financial results on August 14, 2023. The company will also host a conference call to discuss the results and provide a corporate update. The call is expected to include updates on the development of NRX-101, a drug being developed for the treatment of bipolar depression, chronic pain, and other conditions. The companys previous clinical trial of NRX-101 showed a significant improvement in reducing depression and suicidality compared to a placebo.

growth-positive

NRx Pharmaceuticals, Inc. will present a company overview at the H.C. Wainwright 4th Annual Neuropsychiatry Virtual Conference. The company is a clinical-stage biopharmaceutical company developing therapeutics for the treatment of central nervous system disorders. Their lead program, NRX-101, is being investigated in a Phase 2b/3 clinical trial for Suicidal Treatment-Resistant Bipolar Depression. The companys prior Phase 2 trial demonstrated a substantial improvement over available therapy in reducing depression and suicidality.

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NRx Pharmaceuticals has closed its registered direct offering, raising approximately $6.28 million in gross proceeds. The company sold 9,670,002 shares of common stock at a purchase price of $0.65 per share. In addition, the company issued unregistered warrants to purchase up to 9,670,002 shares of common stock. The net proceeds from the offering will be used for working capital, general corporate purposes, and research into the use of NRX-101 for the treatment of PTSD and Chronic Pain. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

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NRx Pharmaceuticals has entered into definitive agreements for a registered direct offering and a concurrent private placement. The company will sell 9,670,002 shares of common stock at a purchase price of $0.65 per share in the offering. In the private placement, unregistered warrants to purchase up to 9,670,002 shares of common stock will be issued. The gross proceeds from the offering are expected to be approximately $6.28 million. NRx Pharmaceuticals intends to use the net proceeds for working capital, general corporate purposes, and research into the use of NRX-101 for the treatment of PTSD and Chronic Pain. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

growth-positive

NRx Pharmaceuticals, Inc. will host a corporate and strategic update conference call. The company is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders. Their lead program, NRX-101, is being investigated in a Phase 2b/3 clinical trial for Suicidal Treatment-Resistant Bipolar Depression. NRx Pharmaceuticals focuses on targeting the brains N-methyl-D-aspartate (NMDA) receptor. The conference call will provide an update on the companys progress and strategy.

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NRx Pharmaceuticals, Inc. has announced its financial results for the first quarter of 2023 and provided a business update. The company is currently conducting a Phase 2b/3 clinical trial for NRX-101, a treatment for Suicidal Treatment-Resistant Bipolar Depression, with data expected in 4Q 2023. The company ended the quarter with $16.5 million in cash and cash equivalents. In March 2023, the company closed a $2.9 million registered direct offering with existing investors. The companys financial results for the first quarter of 2023 recorded $3.7 million of research and development expenses and $5.8 million of general and administrative expenses.

growth-negative

NRx Pharmaceuticals, Inc. has announced the rescheduling of its first quarter quarterly investor conference call due to scheduling conflicts. The companys first quarter 2023 earnings press release is expected to be issued on May 16, 2023, followed by the investor conference call. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, specifically bipolar depression with suicidality and post-traumatic stress disorder (PTSD). Their lead program, NRX-101, is being investigated in a Phase 2b/3 clinical trial for suicidal treatment-resistant bipolar depression. The company has received Special Protocol Agreement and Breakthrough Therapy Designation from the FDA for NRX-101.

growth-neutral

NRx Pharmaceuticals, Inc. will release its first quarter 2023 financial results on May 11, 2023. The company is a clinical-stage biopharmaceutical company developing therapeutics for the treatment of central nervous system disorders. NRx Pharmaceuticals lead program, NRX-101, is being investigated in a Phase 2b/3 clinical trial for suicidal treatment-resistant bipolar depression. The companys prior Phase 2 trial showed promising results in reducing depression and suicidality compared to placebo. The U.S. Food and Drug Administration (FDA) has granted Special Protocol Agreement and Breakthrough Therapy Designation for NRX-101. NRx Pharmaceuticals will host a conference call to discuss the financial results and provide a corporate update on the same day.

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NRx Pharmaceuticals, Inc. has announced its financial results for 2022 and provided a business and clinical update. The company has reinitiated its psychiatry development program and initiated a clinical trial in suicidal treatment-resistant bipolar depression. The trial has been upgraded to a Phase 2b/3 study. The company ended 2022 with $20.1 million in cash and cash equivalents and announced a subsequent $2.9 million registered direct offering in March 2023. Two international leaders in Psychiatry have joined the NRx Advisory Board. The company is also initiating an Expanded Access Program for NRX-101 to serve patients who have exhausted approved medicines for bipolar depression.

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NRx Pharmaceuticals, a clinical-stage central nervous system (CNS) biopharmaceutical company, has announced progress in its interactions with the FDA regarding its lead compound, NRX-101. The company has received a written response from the FDA and held a meeting with them. The FDAs response suggests that NRx Pharmaceuticals has reached alignment with the FDA regarding its proposed registration manufacturing plan. The companys CEO, Stephen Willard, expressed appreciation for the FDAs ongoing guidance and support. NRx Pharmaceuticals is developing therapeutics for the treatment of suicidal depression and post-traumatic stress disorder (PTSD).

growth-positive

NRx Pharmaceuticals has announced enhancements to its Expanded Access and Right to Try programs, which provide patients with respiratory failure from COVID-19 access to ZYESAMI (aviptadil) upon a physicians prescription. The expansion is made possible through NRxs manufacturing partnership with Nephron Pharmaceuticals. ZYESAMI is currently in a Phase 3 clinical trial conducted by the National Institutes of Health (NIH). The drug has shown promising results in clinical trials, with increased odds of survival and recovery from respiratory failure. NRx aims to increase production to meet the demand for ZYESAMI, offering it as a last option for patients who have exhausted all approved therapies. The company is also developing the BriLife COVID vaccine and NRX-101, an investigational medicine for suicidal bipolar depression.

growth-positive

The Israel Institute for Biological Research (IIBR) has sent a shipment of 1,000 vials of the BriLife coronavirus vaccine to Georgia for the second phase of clinical trials. The vaccine is being developed by IIBR and has recently signed a memorandum of understanding with U.S.-based pharmaceutical company NRx for worldwide development, manufacturing, and marketing rights. The trials will involve tens of thousands of volunteers and will be conducted in Israel, Georgia, and Ukraine. BriLife is a self-propagating, live-virus vaccine, differentiating it from mRNA vaccines like Pfizers. The IIBR aims to produce 15 million doses of the vaccine once development is completed.

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NRx Pharmaceuticals has validated the first commercial formulation of ZYESAMI (aviptadil) for intravenous use, allowing for high volume manufacture. They have also achieved a significant increase in the manufactured lot size of aviptadil and a reduction in the cost of its peptide supply. These developments position NRx to potentially deliver millions of doses of ZYESAMI as regulatory approvals are obtained. NRx is in active discussion with national health ministries and regulators regarding Emergency Use Authorization for ZYESAMI. The new formulation allows for immediate shipping worldwide upon potential EUA approval. NRx plans to relaunch its Expanded Access and Right to Try programs as it continues to seek EUA in the United States. NRx Pharmaceuticals is publicly traded on the Nasdaq Global Select Exchange under the stock ticker NRXP.

growth-positive

NRx Pharmaceuticals has signed an agreement with the Israel Institute for Biological Research to jointly develop the BriLife Covid-19 vaccine. The vaccine is in Phase II clinical trials and NRx will complete the trials and commercialization. NRx recently completed a SPAC merger and is currently trading with a market cap of $637 million. The Israel Institute for Biological Research will provide technical assistance, while NRx will supply all required doses of the vaccine for the population of Israel.

growth-positive

Israeli pharmaceutical company NRX Pharmaceuticals has signed a memorandum of understanding with the Israel Institute for Biological Research to jointly develop the latters coronavirus vaccine, BriLife. The vaccine is currently in the second phase of clinical trials. NRX, which recently completed a merger with a SPAC and is now traded on NASDAQ with a market value of approximately $637 million, is expected to complete the trials and commercialize the vaccine.

growth-positive

Israeli drug developer NeuroRX has completed a SPAC merger with US company Big Rock Partners Acquisition Corporation. The merger reflects a company valuation of $1.5 billion for NeuroRX and the company will have $140 million in cash after the merger. NeuroRX has begun trading on Nasdaq as NrX Pharmaceuticals. The company has developed two main treatments, Zyesami for respiratory failure in advanced stages of Covid and a drug for suicidal bipolar depression. Zyesami is in Phase III clinical trials and the company plans to submit it for FDA emergency approval. NeuroRXs shareholders will hold 93% of the merged company.

growth-positive

NeuroRx has been approved for listing on the Nasdaq Global Market via a SPAC merger with Big Rock Partners Acquisition Corp. The company will have an estimated post-transaction value of more than $1.5 billion. NeuroRx plans to use the funds from the offering to continue the development of two investigational medicines. ZYESAMI is being studied in critically-ill patients with COVID-19 induced respiratory failure, and NRX-101 is for patients with suicidal bipolar depression. Both drugs are in FDA-approved phase 3 clinical trials. NeuroRx aims to bring innovative medicines to patients at immediate risk of death who have no currently-approved medicinal therapies.

growth-negative

NeuroRX, an Israeli pharmaceutical company, announced the results of its phase II/III trial for its COVID-19 treatment, ZYESAMI. The drug did not meet its primary endpoint of reducing COVID-19 mortality compared to a control group at day 28. However, it did show a significant reduction in hospitalization days. NeuroRX stated that other drugs have been approved based on this secondary endpoint, but there is no certainty that these results will be sufficient. The company continues to develop products for severe and early-stage COVID-19. NeuroRX is also in talks to merge with SPAC company Big Rock Acquisition Corp. The stock price of both NeuroRX and Relief Therapeutics, its development partner, dropped significantly upon the announcement.

growth-positive

NeuroRx, Inc. has initiated a Phase 2/3 clinical trial in partnership with UCI Health to investigate the role of inhaled ZYESAMI™ (aviptadil) for the treatment of patients with Severe COVID-19. The objective of the study is to determine whether aviptadil can reduce the likelihood of progression to Critical COVID-19 with respiratory failure. The study aims to enroll 144 patients and will also explore the use of inhaled ZYESAMI™ for early-stage COVID-19 and other viral infections. The partnership with UCI Health is crucial as they are a recognized leader in COVID-19 treatment. The potential impact of the treatment is significant in mitigating the ICU and hospital occupancy crisis in the US. NeuroRx is collaborating with Relief Therapeutics on this project.

growth-positive

Israeli pharmaceutical company NeuroRX, which is developing a drug for coronavirus and a drug for depression in advanced stages of clinical trials, has announced a merger with NASDAQ-traded SPAC Big Rock Partners Acquisition Corp. The company is currently valued at $40 million, but with the issuance of approximately 50 million additional shares to NeuroRX, its value is expected to automatically rise to about $780 million. Big Rock raised $60 million in an IPO in 2017 and has been looking for an acquisition target since. NeuroRX has raised $25 million to date from undisclosed investors. A private fund called GEM Global Yield has committed to invest up to $95 million in the company after it goes public.

growth-positive

Big Rock Partners Acquisition Corp. has announced a merger with NeuroRx, Inc., a clinical stage, small molecule pharmaceutical company. NeuroRx develops novel therapeutics for the treatment of COVID-19 and Bipolar Depression. The merger is expected to occur in the first or second quarter of 2021 and the company will continue to trade on the Nasdaq Stock Market under the symbol NRXP. The post-transaction equity value is estimated to be over $500 million.

growth-positive

NeuroRx, Inc. and Relief Therapeutics Holdings AG have met the patient enrollment target for their phase 2b/3 trial of RLF-100 (aviptadil) for treating Respiratory Failure in patients with Critical COVID-19. The ongoing trial aims to develop a much-needed therapy for patients in the Intensive Care Unit (ICU) with Respiratory Failure. The companies have also treated over 200 patients in an FDA-approved Expanded Access Protocol. The trial has shown unexpected rapid recovery in some patients, and no drug-related Serious Adverse Event has been reported. A phase 2b/3 trial for inhaled use of RLF-100 in patients with moderate and severe COVID-19 is expected to start soon. The companies are focused on developing treatments that target vulnerable Type II cells in the lungs. NeuroRx and Relief Therapeutics Holdings AG are working on the development and testing of RLF-100 for COVID-19 treatment.

growth-positive

NeuroRx, Inc. and Relief Therapeutics Holdings AG announced the enrollment of 150 patients in the ongoing phase 2b/3 trial of RLF-100 (aviptadil) for treating respiratory failure in Critical COVID-19 patients. The trial has shown promising results with no drug-related Serious Adverse Events reported so far. The companies are optimistic about the effectiveness of RLF-100 in treating early COVID-19. The completion of enrollment is expected in the coming weeks. The COVID-19 pandemic has posed challenges to the enrollment process due to the strain on hospitals and the temporary incapacity of investigators and study coordinators. NeuroRx and Relief expressed gratitude to the healthcare workers and other personnel involved in the development of the treatment. RLF-100 is a formulation of Vasoactive Intestinal Polypeptide (VIP) that inhibits coronavirus replication and has anti-inflammatory properties.

growth-positive

NeuroRx, Inc. and Relief Therapeutics Holdings AG announced that their COVID-19 treatment, RLF-100™ (aviptadil), is progressing well in its clinical trial. The independent Data Monitoring Committee (DMC) voted unanimously to continue the trial as planned, with no safety concerns identified. RLF-100™ has shown potential in achieving recovery from Respiratory Failure in patients with Critical COVID-19. The trial focuses on patients who already require intensive care for Respiratory Failure, and there is currently no approved drug for this population. The study is expected to complete enrollment by mid-December and yield top-line data in January 2021. RLF-100™ has been granted FDA Fast Track designation and Orphan Drug Designation for the treatment of Acute Respiratory Distress Syndrome.

growth-positive

NeuroRX and Relief Therapeutics reported positive results in a trial for their COVID-19 treatment. The trial involved 45 severely ill COVID-19 patients, with 81% of the patients in the treatment group still alive after 60 days compared to 17% in the control group. Relief Therapeutics stock has increased by 1,500% since entering the COVID-19 field. The companies are also conducting a controlled clinical trial for less severe patients. The results are expected to be published by the end of the year. NeuroRX is responsible for conducting the trials and marketing the product if approved. The companies hope to obtain emergency use authorization for the treatment of severely ill patients.

growth-positive

RELIEF THERAPEUTICS Holding AG and NeuroRx announced positive results from a study on the use of RLF-100 (aviptadil) in treating COVID-19 patients with respiratory failure. The study showed that 81% of RLF-100-treated patients survived beyond 60 days, compared to 17% of control patients. The results suggest that RLF-100 may be effective in mitigating the attack of the coronavirus on the lungs. The company is awaiting results from a randomized, double-blind, prospective trial for confirmation. RLF-100 is a formulation of Vasoactive Intestinal Polypeptide (VIP) and has been granted IND authorization for the treatment of COVID-19. The company is focused on the rapid clinical development of RLF-100 to provide therapeutic relief to critical COVID-19 patients.

growth-positive

NeuroRX has developed a man-made version of human Vasoactive Intestinal Peptide (VIP) called Aviptadil, which has shown promising results in blocking the reproduction of COVID-19, preventing Type II cells death, and stimulating the production of white blood cells. The drug is being tested and will be submitted to the FDA for approval. Aviptadil cannot prevent infection but could potentially save lives. NeuroRXs CEO, Prof. Jonathan Javitt, has a background in public health policy and the company focuses on developing drugs for neglected causes. The companys success with Aviptadil is a result of the FDAs expedited testing process due to the COVID-19 pandemic.

growth-positive

NeuroRx, Inc. has submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100™ aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments. The submission is based on a case-control study that showed significant clinical improvement in patients treated with RLF-100™. The company is working to address requests for RLF-100™ under the appropriate mechanism. The pursuit of EUA status is a crucial component of their effort to bring the drug to patients with severe complications of COVID-19. RLF-100 is a formulation of Vasoactive Intestinal Polypeptide (VIP) that inhibits coronavirus replication and has shown potential in treating respiratory distress.

growth-positive

Relief Therapeutics and NeuroRx have requested emergency approval from the FDA for a drug to repurpose against COVID-19. The drug, RLF-100, has shown promising results in a 51-person study, demonstrating a 3-fold advantage in survival and clinical improvement. If granted, the approval would make the drug available to intensive care patients who have exhausted all approved treatments. Relief Therapeutics aims to provide a new treatment option for COVID-19 patients.

growth-positive

Relief Therapeutics and NeuroRx, Inc. have finalized their partnership agreement for the commercialization of RLF-100 (Aviptadil) worldwide. The companies will share all profits from sales of the drug, with NeuroRx leading commercialization in the U.S., Canada, and Israel, and Relief leading in Europe and the rest of the world. The companies are increasing manufacturing of the drug and are in the final stages of contracting with a fill/finish manufacturer and a national distribution partner. They expect to have manufacturing, distribution and logistics capacity in place by January 2021 to deliver sufficient drug quantities to treat 150K patients per month.

growth-positive

RELIEF THERAPEUTICS Holding SA and NeuroRx, Inc. have completed a partnership agreement for the commercialization of RLF-100™(Aviptadil) worldwide. Relief and NeuroRx will share profits from sales of RLF-100 for all indications related to COVID-19 and potentially other respiratory indications. NeuroRx will lead commercialization in the United States, Canada, and Israel, while Relief will lead commercialization in Europe and the rest of the world. The companies are increasing manufacturing of the aviptadil drug substance and expect to have sufficient capacity to treat 150,000 patients per month by January 2021. They also anticipate reporting top-line data from ongoing clinical trials before the end of 2020. Relief and NeuroRx intend to pursue trademarks on RLF-100. The partnership is aimed at maximizing the value of the franchise and bringing the potentially life-saving drug to patients as quickly as possible.

growth-positive

Relief Therapeutics chairman is optimistic about the approval of their RLF-100 (aviptadil) drug for treating COVID-19 patients. The company owns the rights to the drug in the United States and Europe, and their partner NeuroRx is conducting clinical trials. The chairman expects trial results within a few months and believes there is a 60-70% probability of approval. Relief Therapeutics claims aviptadil is the first COVID-19 therapeutic to block replication of the virus in human lung cells. The anticipation of progress has led to a significant increase in the companys share price.

growth-positive

Critically ill COVID-19 patients have shown rapid recovery from respiratory failure after three days of treatment with RLF-100, a therapy developed by Relief Therapeutics Holdings AG and NeuroRx Inc. RLF-100, also known as aviptadil, is a synthetic form of a natural peptide that protects the lung. The U.S. Food and Drug Administration granted fast-track designation to RLF-100 for the treatment of respiratory distress in COVID-19. The therapy has been administered on an emergency basis to patients who are too ill to be admitted to the ongoing clinical trial. The companies reported positive results, including a 54-year-old man who came off a ventilator within four days of treatment. Clinical trials are ongoing to confirm these observations for less ill patients with COVID-19-related respiratory failure.

growth-positive

NeuroRx and Relief Therapeutics have received FDA authorization to begin a mid-stage trial for the use of Aviptadil to treat acute respiratory distress in coronavirus patients. The companies are in the process of recruiting study sites and pharmacies to begin the trial. Aviptadil is a patented form of vasoactive intestinal polypeptide that has shown promise in treating Acute Respiratory Distress Syndrome (ARDS). If the trial is successful, NeuroRx CEO Jonathan Javitt stated that they have enough drug substance to treat over 1 million people.

growth-positive

NeuroRx, Inc. has received a notice of patent allowance for its drug NRX-101, which targets suicidal bipolar depression. The drug is currently undergoing phase 3 clinical trials. The patent allowance is a growth-positive development for the company.

growth-positive

NeuroRx, Inc has signed an agreement with GEM Global Yield LLC SCS to provide up to HK$ 750 million in funding. The funds will be used to complete phase 3 clinical trials and manufacturing requirements for NRX-101, a breakthrough therapy for suicidal bipolar depression. NeuroRx also plans to initiate phase 2 clinical trials for the treatment of Suicidal Post-traumatic Stress Disorder. The initial funding will be in the form of a capital commitment, and NeuroRx will control the timing and amount of drawdown. The company will issue warrants to GEM to purchase up to 7.5% of the outstanding common stock of the company. The agreement with GEM will help secure funding for the companys growth and development.

growth-positive

NeuroRx, Inc. has initiated a pivotal Phase 2b/3 study for NRX-101, a drug targeting severe bipolar depression and acute suicidal ideation and behavior. NRX-101 has been granted Breakthrough Therapy Designation and Fast Track Designation by the FDA. The study will enroll approximately 140 patients and will compare NRX-101 to lurasidone, the standard of care medication. The primary endpoint is the reduction of depression as measured by the MADRS-10 scale. NeuroRx is addressing a life-threatening condition with an unmet medical need. The study is being conducted at JPS Health Network in Fort Worth, Texas. Bipolar depression affects 5.7 million Americans and can trigger suicidal thoughts and behaviors. NRX-101 is a patented, oral, fixed-dose combination of two FDA-approved drugs. NeuroRx is a privately funded company led by former senior executives of major pharmaceutical companies.

growth-positive

NeuroRx, a clinical stage biopharma company, announced statistically significant final results from its Phase 2 STABIL-B study of NRX-101. The study focused on patients with Severe Bipolar Depression and Acute Suicidal Ideation or Behavior. NRX-101 was granted Breakthrough Therapy Designation by the US FDA. The drug demonstrated significantly lower levels of depression compared to the control group. NRX-101 is a patented, oral, fixed-dose combination of D-cycloserine and lurasidone. NeuroRx has initiated its pivotal P2b/3 study of NRX-101 under Special Protocol Agreement with the FDA.

growth-positive

NeuroRx, a biopharma company, has received FDA clearance to proceed with its phase 2b/3 study protocol for its oral therapy for Acute Suicidal Ideation and Behavior (ASIB) in Bipolar Depression. The clinical trial aims to demonstrate the safety and effectiveness of NRX-101 in maintaining remission from ASIB and depression. NRX-101 is a fixed dose combination of D-Cycloserine and lurasidone. The company is enrolling study sites for the trial. NRX-101 is the first oral drug to target ASIB, a life-threatening condition. The current standard of care involves admission to a psychiatric hospital and electroconvulsive therapy (ECT), which has side effects. NRX-101 aims to achieve the beneficial effects of ECT without the undesirable side effects. The company is also exploring the use of biomarkers to monitor the effect of NRX-101.

growth-positive

NeuroRx, a depression drug developer, won the Conference startup competition at the 2016 IATI-Biomed Conference in Tel Aviv. The company is developing a drug to reduce cases of suicide among depressed patients. The conference also highlighted the success of Israeli university startups, which achieved an aggregate value of $50 billion over 20 years. The conference also discussed the importance of patient feedback and the use of digital medicine to address the growing shortage of doctors and nurses. The article emphasizes the need for new drugs in the areas of anxiety and depression.

growth-positive

Columbia University conducted a trial with eight patients suffering from clinical depression, using a combination of three drugs including ketamine. NeuroRX, a company founded by Jonathan and Daniel Javitt, holds a patent for the combination of these drugs. The trial proved the feasibility of the companys drug and is likely to lead to a broader Phase IIb trial. If successful, the product could reach the market within 4-5 years. NeuroRX has raised undisclosed seed money from biomedical investors, including Chaim Hurvitz. The use of ketamine in the treatment of depression is gaining attention, with other companies also developing ketamine-based treatments.