RedHill Biopharma

growth-negative

RedHill Biopharma Receives Nasdaq Staff Determination Notification

RedHill Biopharma Ltd. received a Staff Determination notification from Nasdaq on October 16, 2025, regarding non-compliance with the minimum stockholders equity requirements for continued listing. The company plans to appeal the determination to a Nasdaq Hearings Panel, which has the authority to grant an extension of up to 180 days for compliance. RedHill believes that a recent transaction with Cumberland Pharmaceuticals Inc. has improved its stockholders equity to exceed the minimum $2.5 million requirement. Despite the appeal, there is no assurance that the Panel will grant an extension or that the outcome will be favorable. RedHill remains listed on the Nasdaq Capital Market pending the hearing.

Oct 22, 2025 ·

growth-negative

On October 16, 2025, the Company received a Staff Determination notification from The Nasdaq Stock Market LLC regarding continued non-compliance with the...

RedHill Biopharma Ltd. received a Staff Determination notification from Nasdaq on October 16, 2025, for non-compliance with the minimum stockholders equity requirements. The company plans to appeal this determination to a Nasdaq Hearings Panel. RedHills recent transaction with Cumberland Pharmaceuticals Inc. is believed to have improved its equity position above the $2.5 million requirement. However, there is no assurance that the Panel will grant an extension or a favorable outcome. RedHill remains listed on the Nasdaq Capital Market pending the hearing. The company focuses on developing and commercializing drugs for gastrointestinal, infectious, and oncology diseases, with several late-stage development programs.

Partners

Oct 20, 2025 ·

growth-positive

RedHill's Talicia® Secures $4 Million Strategic Investment and U.S. Co-Commercialization Partnership Deal

RedHill Biopharma Limited has entered into a strategic partnership with Cumberland Pharmaceuticals Inc., where Cumberland will invest $4 million for a 30% ownership stake in RedHills Talicia business. This partnership aims to accelerate Talicias sales growth in the U.S. by leveraging Cumberlands national sales force and marketing support. The collaboration is expected to deliver cost efficiencies and strengthen RedHills financial position. Talicia, an FDA-approved H. pylori therapy, is patent-protected through 2042 and enjoys market exclusivity. The partnership will see both companies sharing financial performance and operational responsibilities for Talicia, with RedHill retaining 70% ownership.

PartnersInvestment

Oct 20, 2025 ·

growth-positive

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) invests $4 million in exchange for a 30% ownership stake and joint control in RedHill's Talicia business U.S....

RedHill Biopharma Limited has entered into a strategic partnership with Cumberland Pharmaceuticals Inc., which will invest $4 million for a 30% ownership stake in RedHills Talicia business. This partnership aims to accelerate Talicias sales growth in the U.S. by leveraging Cumberlands national sales force and marketing support. Talicia, an FDA-approved therapy for H. pylori infection, is patent protected through 2042 and enjoys market exclusivity. The partnership is expected to enhance operational efficiencies and reinforce RedHills financial position, helping it maintain compliance with Nasdaqs listing requirements. Additionally, RedHill is expanding Talicias market access globally, including new licensing agreements in the Middle East.

PartnersInvestmentCustomers

Oct 20, 2025 ·

growth-positive

CUMBERLAND PHAMACEUTICALS ANNOUNCES THE ADDITION OF AN ESTABLISHED FDA APPROVED PRODUCT TO ITS COMMERCIAL PORTFOLIO

Cumberland Pharmaceuticals Inc. has entered into a strategic partnership with RedHill Biopharma Ltd. to jointly commercialize Talicia®, an FDA-approved therapy for Helicobacter pylori infection. Under the agreement, Cumberland will invest $4 million and assume responsibility for distribution and sales, while RedHill contributes Talicia assets and international licenses. The collaboration aims to leverage Cumberlands sales force to expand Talicias market reach. Talicia, noted for its high eradication rates and simplicity, is now a first-line treatment option in updated guidelines. This partnership is expected to drive revenue growth and strengthen Talicias market leadership.

PartnersInvestmentCustomers

Oct 6, 2025 ·

growth-positive

RedHill Biopharma Signs New $1.8 Million Plus Sales Royalties Middle East Deal For Talicia®

RedHill Biopharma Ltd. has announced a licensing deal for its FDA-approved therapy, Talicia, to enter new Middle East markets. The agreement includes $500,000 in guaranteed payments, with $250,000 upfront and $250,000 due within 18 months, alongside potential milestone payments of at least $1.3 million and tiered royalties on net sales. Talicia, a low-dose rifabutin-based therapy, is the leading branded treatment for H. pylori in the U.S. and is patent protected until 2042. This deal aims to expand patient access in regions with high H. pylori prevalence and antibiotic resistance, supporting RedHills global market-building efforts.

Partners

Oct 6, 2025 ·

growth-positive

The deal aims to accelerate Talicia's entry into new Middle East markets Under the terms of the agreement RedHill will receive $500,000 in guaranteed payments,...

RedHill Biopharma Ltd. has announced a licensing agreement for its FDA-approved drug Talicia, aimed at expanding its market reach into the Middle East. The deal includes $500,000 in guaranteed payments and potential milestone payments of at least $1.3 million, along with tiered royalties on sales. Talicia, a therapy for H. pylori infection, is the leading branded treatment prescribed by U.S. gastroenterologists and is patent protected until 2042. The agreement is expected to accelerate Talicias entry into new markets, addressing the high prevalence of H. pylori in the region. This move is part of RedHills strategy to expand global access to Talicia and secure additional revenue streams.

Product StageCustomersPartners

Sep 29, 2025 ·

growth-positive

The New York Supreme Court has, on appeal, upheld its original summary judgment ruling in favor of RedHill The New York Supreme Court unequivocally dismissed...

RedHill Biopharma Ltd. has achieved a legal victory as the New York Supreme Court upheld a summary judgment in its favor against Kukbo Co. Ltd. The court ruled that RedHill fulfilled its obligations under the agreements, despite Kukbos breach. RedHill has been awarded approximately $10 million, including legal costs. Additionally, RedHill secured an attachment grant from Koreas Incheon District Court to prevent Kukbo from disposing of assets before judgment enforcement. RedHill focuses on developing and commercializing drugs for gastrointestinal, infectious, and oncology diseases, with FDA-approved Talicia® for H. pylori infection. The company is involved in late-stage development programs for various conditions.

Sep 29, 2025 ·

growth-positive

RedHill Wins New York Supreme Court Appeal, Upholding $10 Million Summary Judgment Against Kukbo

RedHill Biopharma Ltd., a specialty biopharmaceutical company, has secured a legal victory in the New York Supreme Court against Kukbo Co. Ltd. The court upheld its original summary judgment in favor of RedHill, awarding the company approximately $10 million, including legal costs and statutory interest. The judgment confirmed that RedHill fulfilled its obligations under the agreements with Kukbo, which was found in breach. Additionally, RedHill obtained a court-ordered asset seizure against Kukbo in Korea. RedHill focuses on developing and commercializing drugs for gastrointestinal, infectious, and oncological diseases, with several late-stage clinical programs. The company promotes the FDA-approved drug Talicia® for H. pylori infection and collaborates with Hyloris Pharma for worldwide development of RHB-102 outside North America.

Sep 5, 2025 ·

growth-positive

RedHill Biopharma Announces First Half 2025 Financial Results and Operational Highlights

RedHill Biopharma Ltd. reported significant progress in its strategic, financial, and operational overhaul, leading to a positive impact on the company. The company initiated recruitment for a Bayer-supported Phase 2 study in prostate cancer and received positive FDA feedback for its Crohns disease program. RedHill achieved increased revenues and expanded its customer base for Talicia in the U.S., with a UK Marketing Authorization Application submission imminent. A $60 million out-licensing deal was signed with Hyloris Pharmaceuticals. Financially, RedHill doubled its gross profit and increased net revenues by 59% in the first half of 2025. The company also secured a legal victory in New York and Korea against Kukbo.

Product StageCustomersPartnersInvestment

Aug 20, 2025 ·

growth-positive

RedHill Biopharma Awarded $1.8 Million in Legal Costs and Expenses by New York Supreme Court in Addition to its Prior $8.25 Million Summary Judgment Win

RedHill Biopharma Ltd., a specialty biopharmaceutical company, has been awarded approximately $1.82 million in legal costs and expenses by the New York Supreme Court in its case against Kukbo Co. Ltd. This award is in addition to a prior summary judgment of approximately $8.25 million in favor of RedHill. Both awards include a 9% ongoing statutory interest accrual. RedHill also succeeded in obtaining an attachment grant from Koreas Incheon District Court against Kukbo, preventing the disposal of Kukbos assets before judgment enforcement. Kukbo has appealed the summary judgment decision, with oral arguments scheduled for the September term. RedHill focuses on developing and commercializing drugs for gastrointestinal diseases, infectious diseases, and oncology, with several late-stage clinical programs.

Aug 20, 2025 ·

growth-positive

/PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the New York...

RedHill Biopharma Ltd. has been awarded approximately $1.82 million in legal costs and expenses by the New York Supreme Court, in addition to a prior summary judgment of $8.25 million against Kukbo Co. Ltd. The courts decision includes a 9% ongoing statutory interest accrual. RedHill also secured an attachment grant from Koreas Incheon District Court, preventing Kukbo from disposing of assets before judgment enforcement. Kukbo has appealed the summary judgment, with oral arguments scheduled for September. RedHill focuses on developing and commercializing drugs for gastrointestinal and infectious diseases, with several late-stage clinical programs. The company promotes the FDA-approved drug Talicia® for H. pylori infection treatment.

Aug 18, 2025 ·

growth-positive

RedHill Received Talicia® Licensing Payments Totaling $1.1 Million

RedHill Biopharma Ltd. has announced its first sales milestone payment for Talicia, totaling $1.1 million, following the ex-U.S. commercial launch in 2024. Talicia is the first FDA-approved rifabutin-based product for treating Helicobacter pylori, a bacterial infection affecting over 50% of the global adult population and a major risk factor for gastric cancer and peptic ulcer disease. The product has been granted a Qualified Infectious Disease Product designation by the FDA, ensuring eight years of U.S. market exclusivity. RedHill is actively seeking additional non-dilutive ex-US licensing revenue streams to expand Talicias reach globally. The company highlights Talicias effectiveness against antibiotic-resistant strains of H. pylori, contrasting it with declining efficacy of clarithromycin-based therapies.

CustomersFDA approved/pending approval

Aug 18, 2025 ·

growth-positive

RedHill has received its first Talicia sales milestone payment as well as royalties and other payments, totaling $1.1 million, following the first ex-U.S....

RedHill Biopharma Ltd. has received its first sales milestone payment for Talicia, totaling $1.1 million, following its first ex-U.S. commercial launch in 2024. Talicia is the first FDA-approved rifabutin-based product specifically designed to treat Helicobacter pylori (H. pylori), a bacterial infection with high resistance rates. It is the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori infection. The product is patent protected through 2042 and has been granted a Qualified Infectious Disease Product (QIDP) designation by the FDA, providing eight years of U.S. market exclusivity. RedHill is in discussions with potential partners to secure additional non-dilutive ex-US licensing revenue streams.

CustomersFDA approvedPartners

Jul 21, 2025 ·

growth-positive

The positive FDA feedback allows for: A novel Phase 2 RHB-204[1] study, planned to be the first ever clinical study in a specifically defined Mycobacterium...

RedHill Biopharma Ltd. received positive feedback from the FDA for its RHB-204 Crohns disease development program. The feedback supports a novel Phase 2 study targeting MAP-positive Crohns disease patients, potentially making RHB-204 a paradigm-shifting therapy. The company has initiated collaborations with leading academic centers for advanced MAP detection diagnostics, addressing a major barrier in previous studies. The study design allows for lower costs and faster completion. RedHill is pursuing non-dilutive funding and expects to benefit from regulatory designations. The Crohns disease market is projected to grow significantly, presenting substantial commercial potential for RHB-204.

Product StagePartners

Jul 21, 2025 ·

growth-positive

RedHill Receives Positive FDA Feedback on Pathway to Approval of Groundbreaking RHB-204 for Crohn's Disease

RedHill Biopharma Ltd. has received positive feedback from the FDA for its RHB-204 Crohns disease development program. The feedback supports a novel Phase 2 clinical trial targeting MAP-positive Crohns disease patients, potentially making RHB-204 a paradigm-shifting therapy. The company has initiated collaborations with leading academic centers to advance its anti-MAP program. The program is expected to be funded through non-dilutive means, with grant applications and discussions for additional financing ongoing. The RHB-204 formulation is patent-protected through 2041 and has shown significant efficacy in Phase 3 trials. The Crohns disease market is projected to grow significantly, presenting substantial commercial potential for new FDA-approved therapies.

Product StagePartners

Jul 1, 2025 ·

Sector Update: Health Care Stocks Rise in Late Afternoon Trading

The article is a brief mention of health care stocks advancing late Tuesday afternoon, with references to the NYSE Health Care Index. It does not provide specific details about any particular company, investment, or event. The text is part of a premium news service, suggesting that more detailed information is available to subscribers. No specific company actions, partnerships, or financial details are discussed in the provided text.

Jul 1, 2025 ·

growth-positive

RedHill Biopharma Announces Recruitment Initiated into Expanded Phase 2 Opaganib/Darolutamide Combination Study in Advanced Prostate Cancer

RedHill Biopharma Ltd. has initiated patient recruitment for a Phase 2 clinical trial to evaluate the efficacy of opaganib in combination with darolutamide for treating metastatic castrate-resistant prostate cancer (mCRPC). The study, sponsored by ANZUP and supported by Bayer and Ramsay Hospital Research Foundation, aims to recruit 60 patients across Australia and New Zealand. It employs a precision medicine approach using the PCPro lipid biomarker test to identify patients likely to benefit from the treatment. The trials primary endpoint is improved 12-month radiographic progression-free survival. This initiative marks a significant step in RedHills oncology development, complementing its other medical countermeasures and infectious diseases programs.

Product Stage

Jul 1, 2025 ·

growth-positive

Recruitment initiated into the Phase 2 opaganib plus darolutamide study in patients with advanced prostate cancer, sponsored by ANZUP, and supported by Bayer...

RedHill Biopharma Ltd. has initiated a Phase 2 clinical trial to evaluate the efficacy of opaganib in combination with darolutamide for treating metastatic castrate-resistant prostate cancer (mCRPC). The study, sponsored by ANZUP and supported by Bayer and Ramsay Hospital Research Foundation, aims to recruit 60 patients across Australia and New Zealand. The trial will use the PCPro lipid biomarker test to identify patients with poor prognosis who might benefit from the treatment. This marks a significant step in RedHills oncology development, complementing its other medical countermeasures and infectious diseases programs.

Product StagePartners

May 13, 2025 ·

growth-positive

RedHill Biopharma Secures Kukbo Asset Freeze Following RedHill's $8.25 Million Plus Legal Fees New York Supreme Court Summary Judgment Win

RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced a legal victory in its favor against Kukbo Co. Ltd. The New York Supreme Court ruled in favor of RedHill, granting a summary judgment of approximately $8.25 million plus legal fees and costs. The court also dismissed all counterclaims by Kukbo. RedHill successfully secured an attachment petition in South Korea to prevent Kukbo from disposing of assets before the enforcement of the judgment. The judgment includes accrued interest due to Kukbos failure to pay according to subscription and licensing agreements. Kukbo has filed a notice of appeal, with a deadline to perfect it by June 4, 2025. RedHill focuses on developing and commercializing drugs for gastrointestinal and infectious diseases, with several late-stage clinical programs.

Product StagePartners

May 2, 2025 ·

growth-positive

RedHill-Supported Medscape H. Pylori Educational Program to Launch at Major Gastroenterology Congress

RedHill Biopharma Ltd. announced its support for an independent medical education grant that includes a new two-part Continuing Medical Education (CME) program on H. pylori, developed by Medscape. The program aims to advance clinical knowledge and improve patient outcomes, with the first part being a livestreamed event led by notable medical professionals. H. pylori is a significant health concern, classified as a Group 1 carcinogen by the WHO and a major risk factor for gastric cancer and peptic ulcer disease. RedHills Talicia® is the leading FDA-approved therapy for H. pylori, addressing antibiotic resistance issues. The company will also participate in Digestive Diseases Week in San Diego, emphasizing its commitment to educating healthcare professionals on effective H. pylori management.

Apr 28, 2025 ·

growth-positive

RedHill Biopharma Secures Allowance of Key Chinese Patent Application for Proprietary COVID-19 Treatment, RHB-107

RedHill Biopharma Ltd. announced that the China National Intellectual Property Administration has granted a composition-of-matter patent for its investigational compound RHB-107, an oral treatment for COVID-19. This patent enhances RedHills strategic positioning in the global COVID-19 therapeutic market, expected to be worth over $3 billion by 2025. RHB-107 has shown promising results in a U.S. Phase 2 study, meeting safety and tolerability endpoints. The patent provides market exclusivity and expands RedHills patent footprint in Asia, a key pharmaceutical market. RHB-107 is a novel antiviral expected to act independently of viral spike protein mutations, offering a potential treatment option alongside Pfizers Paxlovid.

Product StageFDA approved/pending approval

Apr 28, 2025 ·

growth-positive

Strong Use of Composition-of-Matter Coverage: Patent protects the molecular structure of RHB-107, providing market exclusivity beyond method-of-use claims...

RedHill Biopharma Ltd. has received approval from the China National Intellectual Property Administration for a composition-of-matter patent for its investigational compound RHB-107, an oral treatment for COVID-19. This patent enhances RedHills strategic positioning in the global COVID-19 therapeutic market, expected to be worth over $3 billion by 2025. RHB-107 has shown promising results in a U.S. Phase 2 study, demonstrating significant reductions in hospitalization and severe symptoms. The patent provides robust protection for RHB-107s use in treating SARS-CoV-2 infections, including variants, and expands RedHills patent footprint in Asia. The company is advancing RHB-107 for early, community-based COVID-19 treatment.

Product StageFDA approved/pending approval

Apr 17, 2025 ·

growth-negative

RedHill Biopharma Receives Nasdaq Notification Regarding Minimum Stockholders' Equity Deficiency

RedHill Biopharma Ltd., a specialty biopharmaceutical company, received a notification from Nasdaq indicating non-compliance with the Nasdaq Listing Rule 5550(b)(1), which requires a minimum of $2,500,000 in stockholders equity. The companys annual report showed a stockholders deficit of $4,683,000. Although the notification does not immediately affect the companys Nasdaq listing or operations, RedHill has 45 days to submit a compliance plan. The company is exploring options to regain compliance and maintain its listing. RedHill focuses on developing and commercializing drugs for gastrointestinal and infectious diseases, with several late-stage clinical programs underway.

Public Trading

Apr 16, 2025 ·

growth-positive

RedHill Biopharma's Positive Opaganib Weight Loss & Diabetes Data Published: Signals Potential $100B Market Disruption

RedHill Biopharma Ltd. announced positive preclinical results for its drug Opaganib, which demonstrated comparable efficacy to semaglutide in promoting weight loss and improving metabolic markers in obesity and diabetes models. Opaganib, an oral, non-peptide therapeutic, targets sphingosine kinase-2, potentially avoiding common side effects of GLP-1 inhibitors. The drugs novel mechanism and existing human safety data could expedite its FDA approval process. The global obesity-diabetes market is projected to reach $100 billion by 2034, positioning Opaganib as a potential market disruptor. The study suggests Opaganibs potential as a first-in-class treatment for obesity-related disorders.

Product StageFDA approved/pending approval

Apr 10, 2025 ·

growth-positive

RedHill Biopharma Announces Full-Year 2024 Financial Results and Operational Highlights

RedHill Biopharma Ltd. reported its 2024 financial results, highlighting a 23% increase in net revenues and significant cost-cutting measures. The company secured a global licensing deal with Hyloris Pharmaceuticals for RHB-102, potentially worth $60 million. RedHill also won a legal judgment worth approximately $8 million. The company is advancing its RHB-204 into a Phase 2 clinical study for Crohns Disease and has initiated a Phase 2 study in prostate cancer with Bayer. Talicia® has expanded geographically, with a successful launch in the UAE and plans for a UK Marketing Authorisation Application. The companys cash balance stands at $4.8 million, with a significant reduction in cash burn due to strategic divestitures and reduced R&D spending.

Product StagePartnersCustomersInvestment

Mar 31, 2025 ·

uk.finance.yahoo.com

growth-positive

Surrey loses rush-hour taxis to thousands of school runs

AMK Chauffeur Drive, a large taxi firm, has experienced a significant increase in demand for school transport services, primarily driven by contracts with Surrey County Council and other local councils. These contracts, which account for 90% of the companys revenue, involve transporting children to and from school, including those with special educational needs (Send). The high demand for school transport has led to a shortage of available taxis for other customers during morning hours, impacting local residents ability to book rides. The reliance on council contracts has proven lucrative for the company, with similar trends observed by other taxi firms in the region.

CustomersPartners

Mar 18, 2025 ·

growth-positive

RedHill Biopharma to Submit FDA-Approved Talicia® for UK Marketing Authorisation

RedHill Biopharma Ltd. plans to submit a UK Marketing Authorisation Application (MAA) for Talicia, a treatment for H. pylori infection, under the UKs Medicines and Healthcare products Regulatory Agencys (MHRA) fast-track approval process. Talicia, already FDA-approved in the U.S., is the leading branded therapy for H. pylori prescribed by U.S. gastroenterologists. The company aims for potential UK approval by Q4 2025, which could facilitate further international approvals. H. pylori is a significant market opportunity, affecting a large portion of the global population and being a major risk factor for gastric cancer. RedHill is exploring partnerships to expand Talicias global reach, leveraging its proven efficacy and safety profile.

Product StagePartners

Mar 18, 2025 ·

RedHill plans to submit UK MAA1 for Talicia for H. pylori infection, using MHRA's2 new fast-track approval process, referencing FDA approval, with potential UK...

Mar 12, 2025 ·

The planned innovative Phase 2 study of RHB-2041 will be the first ever clinical study in Crohn's Disease (CD) patients who are all MAP-positive, and will...

Mar 12, 2025 ·

growth-positive

RedHill Biopharma Advances its Groundbreaking Late-Stage Crohn's Disease Program Building on Statistically Significant Positive RHB-104 Phase 3 Results

RedHill Biopharma Ltd. announced plans to initiate a Phase 2 clinical study of RHB-204, targeting Mycobacterium avium subspecies paratuberculosis-positive (MAP+) moderate to severe Crohns Disease (CD). This study aims to correlate mucosal healing with MAP infection eradication using novel endpoints and imaging techniques. The study is pending Type C discussions with the FDA, with guidance expected in Q2 2025. RHB-204 is a next-generation anti-MAP therapy, derived from RHB-104, which showed significant efficacy in a Phase 3 study. The studys design, focusing on MAP-positive patients, is expected to demonstrate consistent benefits and reduce costs. The Crohns disease market is projected to grow significantly, offering substantial commercial potential for FDA-approved therapies.

Product Stage

Feb 27, 2025 ·

growth-positive

Guy Goldberg, RedHill's Chief Business Officer, presents today a business update at the European Life Sciences CEO Forum The update covers: The recent...

RedHill Biopharma Ltd. presented a business update at the European Life Sciences CEO Forum, highlighting significant corporate activities and progress. The company announced the out-licensing of RHB-102 to Hyloris in a deal potentially worth $60 million plus royalties. A Bayer-funded Phase 2 clinical study of opaganib in combination with Bayers darolutamide for advanced prostate cancer has been initiated. The company is making commercial progress with Talicia®, which has surpassed 100,000 prescriptions and gained inclusion in the ACG Clinical Guideline. Talicia® has also been launched in the UAE, and discussions are ongoing for further market expansion. The FDA has approved a more convenient dosing regimen for Talicia®, and Humanas Part D Plan coverage now includes it, adding access for over eight million Medicare lives.

Product StagePartnersCustomersFDA approved/pending approval

Feb 27, 2025 ·

growth-positive

RedHill Presents Business Update at the Sachs' European Life Sciences CEO Forum

RedHill Biopharma Ltd. presented a business update highlighting significant corporate activities and progress. The company out-licensed RHB-102 to Hyloris in a deal potentially worth $60 million plus royalties. A Bayer-funded Phase 2 clinical study of opaganib in combination with darolutamide for advanced prostate cancer has been initiated. RedHills Talicia has achieved significant milestones, including surpassing 100,000 prescriptions and being included as a first-line option in the ACG guideline for H. pylori infection. The company is also expanding Talicias market reach, with recent launches in the UAE and potential new markets under evaluation. The FDA approved a more convenient TID dosing for Talicia, and Humanas Part D Plan now covers over eight million additional Medicare lives.

Product StagePartnersCustomers

Feb 26, 2025 ·

www.pharmaceutical-technology.com

growth-positive

RedHill and Hyloris sign agreement for Bekinda’s development

RedHill Biopharma has entered into an exclusive licensing agreement with Hyloris Pharmaceuticals for the global development and commercialization of RHB-102 (Bekinda), excluding North America. RedHill will receive an upfront payment and may earn up to $60 million in milestone payments, along with royalties. Hyloris will manage development and regulatory processes in its territories. RedHill is advancing RHB-102 for FDA approval, with the drug intended to provide 24-hour relief from nausea and vomiting for cancer patients and those with gastrointestinal conditions. The UK’s MHRA has given positive advice, and a US Phase III study has been completed successfully.

PartnersProduct Stage

Feb 25, 2025 ·

growth-positive

- Hyloris will pay RedHill an upfront payment and up to $60 million in potential milestone payments, plus up to mid-20s percent royalties on revenues, in...

RedHill Biopharma Ltd. has entered into an exclusive licensing agreement with Hyloris Pharmaceuticals SA for the development and commercialization of RHB-102 (Bekinda®) outside North America. Hyloris will pay RedHill an upfront fee, potential milestone payments up to $60 million, and royalties. The agreement follows positive UK MHRA advice for a UK Marketing Authorization Application for RHB-102, which could become the first oral 24-hour extended-release ondansetron for chemotherapy/radiotherapy-induced nausea and vomiting. RedHill will continue to pursue FDA approval in the U.S. The global antiemetics market is valued at $7.5 billion, with expected growth. The partnership is expected to enhance patient care in oncology and gastroenteritis.

Partners

Feb 25, 2025 ·

growth-positive

RedHill Licenses RHB-102 for Commercialization Worldwide Excluding North America to Hyloris for up to $60 Million in Potential Milestone Payments Plus Royalties

RedHill Biopharma Ltd. has entered into an exclusive worldwide development and commercialization licensing agreement with Hyloris Pharmaceuticals SA for its drug RHB-102 (Bekinda®), excluding North America. Hyloris will pay RedHill an upfront payment and up to $60 million in milestone payments, plus royalties, for the rights to develop and commercialize RHB-102 outside the U.S., Canada, and Mexico. RedHill will continue to seek FDA approval for RHB-102 in the U.S. RHB-102 is an extended-release oral tablet for treating nausea and vomiting induced by chemotherapy/radiotherapy, among other indications. The agreement is expected to positively impact RedHills growth.

Partners

Feb 5, 2025 ·

www.clinicaltrialsarena.com

growth-positive

RedHill Biopharma launches trial of combination therapy for prostate cancer

Israeli pharmaceutical company RedHill Biopharma has initiated a Phase II clinical trial to evaluate the combination of opaganib and darolutamide for treating metastatic castrate-resistant prostate cancer (mCRPC). The trial, financially supported by Bayer and the Ramsay Hospital Research Foundation, involves 80 male subjects and aims to enhance the effects of standard androgen receptor pathway inhibition treatments. The primary endpoint is the improvement in 12-month radiographic progression-free survival. The study is led by Prof Lisa Horvath and the ANZUP group. Opaganib is an investigational therapy with potential applications in various conditions, including cancer and viral infections.

Product Stage

Feb 4, 2025 ·

growth-positive

RedHill Announces Initiation of Phase 2 Study of Opaganib and Darolutamide in Advanced Prostate Cancer

RedHill Biopharma Ltd. has initiated a Phase 2 clinical trial to evaluate the efficacy of opaganib in combination with Bayers darolutamide for treating metastatic castrate-resistant prostate cancer (mCRPC). The study, financially supported by Bayer and the Ramsay Hospital Research Foundation, aims to test the potentially enhancing effect of opaganib in patients with poor prognosis. Led by Professor Lisa Horvath and the ANZUP group, the trial will use a companion lipid biomarker test to select suitable patients. The primary endpoint is improved 12-month radiographic progression-free survival. This development is part of RedHills broader efforts in oncology and other therapeutic areas.

Product StagePartners

Feb 4, 2025 ·

growth-positive

The 80-patient placebo-controlled randomized Phase 2 study will evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with...

RedHill Biopharma has initiated a Phase 2 clinical trial to evaluate the efficacy of opaganib in combination with Bayers darolutamide for treating metastatic castrate-resistant prostate cancer (mCRPC). The study, financially supported by Bayer and the Ramsay Hospital Research Foundation, aims to test the potential of opaganib to enhance the effectiveness of darolutamide in patients with poor prognosis. The trial will involve 80 patients and utilize a companion lipid biomarker test to select suitable candidates. The primary endpoint is improved 12-month radiographic progression-free survival. This collaboration represents a significant step in addressing treatment resistance in mCRPC, potentially improving patient outcomes.

Product StagePartnersInvestment

Feb 4, 2025 ·

growth-positive

The 80-patient placebo-controlled randomized Phase 2 study will evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with...

RedHill Biopharma Ltd. has initiated a Phase 2 clinical study to evaluate the efficacy of opaganib in combination with Bayers darolutamide for treating metastatic castrate-resistant prostate cancer (mCRPC). Supported financially by Bayer and the Ramsay Hospital Research Foundation, the study aims to test opaganibs potential to enhance treatment efficacy in patients with poor prognosis. The trial will use a lipid biomarker test to select suitable patients and aims to improve 12-month radiographic progression-free survival. This collaboration represents a significant step in addressing treatment-resistant mCRPC, a market valued at approximately $12 billion. The study is led by Professor Lisa Horvath and involves multiple partners, including the Australian and New Zealand Urogenital and Prostate Cancer Trials Group.

Product StagePartnersInvestment

Jan 21, 2025 ·

growth-positive

RedHill's Talicia® Adds 8 Million Lives With Coverage by Humana®'s Part D Plan. Also, New Data Supporting Simplified Three-Times Daily Talicia Dosing Published

RedHill Biopharma Ltd. announced that its product, Talicia, is now covered by Humanas Part D Plan, expanding access to over eight million additional Medicare lives. This coverage does not require prior therapeutic steps or authorizations, benefiting both treatment-naïve and treatment-experienced patients. Talicia is recognized as a first-line treatment for H. pylori infection by the American College of Gastroenterology. The company also highlighted a recent FDA-approved label change for Talicia, allowing a more convenient dosing routine, which supports patient adherence. This development is expected to enhance Talicias market presence and improve treatment outcomes for patients with H. pylori infection.

Customers

Dec 10, 2024 ·

growth-positive

Radioprotective Activity of RedHill's Opaganib for GI-ARS Confirmed in New RNCP/NIAID Study - Discussions Ongoing with U.S. Government on Advanced Development

RedHill Biopharma Ltd. announced positive results from in vivo studies of opaganib as a treatment for gastrointestinal acute radiation syndrome (GI-ARS). These studies are part of the U.S. governments Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract. RedHill is collaborating with the National Institutes of Allergy and Infectious Diseases (NIAID) to discuss the next phase of opaganibs development along the FDAs Animal Rule pathway. This pathway allows for pivotal animal model efficacy studies to support FDA approval when human trials are not feasible. The development of opaganib is timely given the growing geopolitical tensions and Homeland Security concerns, as it could be stockpiled by governments for emergency use.

Partners

Dec 3, 2024 ·

growth-positive

RedHill Biopharma awarded judgement of approx $8M by NY Supreme Court

RedHill Biopharma has been awarded approximately $8 million, plus costs, in a summary judgment by the Supreme Court of the State of New York against Kukbo Co. Ltd. The case involved Kukbos failure to make agreed payments under a Subscription Agreement and a subsequent Exclusive License Agreement. This legal victory is a positive development for RedHill, potentially enhancing its financial position. The company is also involved in various collaborations, including with Duke University and BARDA, focusing on the development and funding of treatments like Opaganib for Ebola. These partnerships highlight RedHills strategic efforts to expand its research and development capabilities.

Partners

Dec 2, 2024 ·

growth-positive

RedHill Biopharma Awarded Judgment of Approximately $8 Million Plus Costs by New York Supreme Court

RedHill Biopharma Ltd., a specialty biopharmaceutical company, has been awarded a judgment of approximately $8 million plus costs by the New York Supreme Court in its legal proceedings against Kukbo Co. Ltd. The court dismissed Kukbos counterclaims, ruling in favor of RedHills adherence to their agreements. This judgment stems from Kukbos failure to make agreed payments under a Subscription Agreement and an Exclusive License Agreement. RedHills CEO, Dror Ben-Asher, expressed gratitude for the courts decision and the legal representation by Haynes and Boone, LLP. RedHill focuses on the commercialization and development of drugs for gastrointestinal diseases, infectious diseases, and oncology, with several key clinical programs in late-stage development.

Dec 2, 2024 ·

growth-positive

/PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the Company has...

RedHill Biopharma Ltd., a specialty biopharmaceutical company, has been awarded a judgment of approximately $8 million plus costs by the New York Supreme Court in its legal proceedings against Kukbo Co. Ltd. The court ruled in favor of RedHill, dismissing Kukbos counterclaims and affirming RedHills commitment to the agreements between the two companies. The case involved Kukbos failure to make agreed payments under a Subscription Agreement and an Exclusive License Agreement. RedHills CEO, Dror Ben-Asher, expressed gratitude for the judgment and the legal representation by Haynes and Boone, LLP. RedHill intends to pursue attorneys fees and collection of the judgment. Kukbo has the right to appeal the judgment. RedHill focuses on the commercialization and development of drugs for gastrointestinal and infectious diseases, with several key clinical programs in progress.

Oct 28, 2024 ·

growth-positive

RedHill Selected to Present Opaganib at Conference Organized by U.S. Government's JPEO-CBRND

RedHill Biopharma Ltd. has been selected to present the potential of its drug opaganib at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defenses (JPEO-CBRND) Host Directed Therapeutics Industry Day. This event, scheduled for October 29-30, 2024, in Alexandria, VA, will allow RedHill to showcase opaganibs capabilities in treating viral infections, oncology, and other conditions. The selection for presentation indicates recognition of opaganibs potential by U.S. government representatives, which could lead to further collaborations and investments in chemical, biological, radiological, and nuclear defense. This opportunity is a positive development for RedHill, enhancing its visibility and potential partnerships in the defense sector.

Oct 23, 2024 ·

growth-positive

RedHill Biopharma and Duke Collaborate on Opaganib Development

RedHill Biopharma has announced a collaboration with Duke University School of Medicine to develop opaganib as a treatment for phosgene inhalation injury, a significant public safety threat. This partnership aims to advance the drugs development under FDA guidelines, addressing the current lack of approved antidotes for this toxic industrial chemical. The collaboration highlights opaganibs broad potential applications and its importance in chemical and pandemic preparedness, as it is also being evaluated by U.S. government programs. This development is likely to have a positive impact on RedHill Biopharmas growth prospects.

Partners

Oct 22, 2024 ·

growth-positive

RedHill Announces Collaboration with a Leading U.S. Academic Medical Center to Develop Opaganib as a Countermeasure Against Phosgene Inhalation Injury

RedHill Biopharma Ltd. has announced a collaborative research agreement with Duke University School of Medicine to conduct multiple in vivo studies on opaganib, a clinical-stage drug. The studies aim to test opaganib as a potential treatment for phosgene inhalation injury, a toxic chemical exposure with no current antidote. The collaboration seeks to advance opaganib into further U.S. government-sponsored development under the FDAs Animal Rule pathway, which allows for drug approval based on animal model efficacy studies when human trials are not feasible. This partnership could lead to significant advancements in emergency preparedness and chemical countermeasures, potentially providing a stockpiling option for opaganib in public safety incidents.

Partners

Oct 14, 2024 ·

growth-positive

RedHill Biopharma Secures U.S. Government Funding through BARDA to Advance Opaganib for Ebola Treatment

RedHill Biopharma Ltd. has been selected by the U.S. governments Biomedical Advanced Research and Development Authority (BARDA) for the development and funding of opaganib as a medical countermeasure against Ebola virus disease (EBOV). This collaboration aims to advance opaganibs development on the FDA Animal Rule pathway, potentially leading to its approval for treating EBOV. Opaganib has shown promising results in increasing survival rates in EBOV models and demonstrates mutation-resistant antiviral and anti-inflammatory properties. The partnership with BARDA is a significant step in addressing the urgent need for effective EBOV therapies, especially in regions with limited healthcare infrastructure. This development is part of RedHills broader strategy to enhance its portfolio of treatments for infectious diseases and other health conditions.

Partners

Oct 1, 2024 ·

growth-positive

RedHill and Medi-Cal Deal Maintains Talicia® Reimbursement Without Prior Authorization for 15 Million Californians

RedHill Biopharma has renewed its contract with Medi-Cal, Californias Medicaid healthcare program, to maintain Talicias first-line position on the Medi-Cal Fee-For-Service (FFS) Contract Drug List (CDL) with no prior authorization and a $0 copay. This renewal, effective October 1, 2024, ensures continued access to Talicia for approximately 15 million Medi-Cal patients. The agreement underscores the efficacy and safety of Talicia, which is now listed as an empirically prescribed first-line option in the new American College of Gastroenterology (ACG) Clinical Guideline for H. pylori infection. Talicia is a convenient, all-in-one therapy for H. pylori, a significant risk factor for gastric cancer and peptic ulcer disease.

CustomersPartners

Oct 1, 2024 ·

growth-positive

RedHill Biopharma Secures Opaganib COVID-19 Patent

RedHill Biopharma Ltd. has announced a new U.S. patent for its drug Opaganib, which targets the treatment of COVID-19. The patent, valid through 2041, covers the identification of a novel biomarker predictive of the drug’s effectiveness. Published data indicates significant patient improvements, including better oxygenation, reduced intubation needs, and lower mortality rates. Opaganib is an orally administered drug with potential applications in several diseases and is part of U.S. government collaborations for pandemic preparedness.

Sep 30, 2024 ·

growth-positive

RedHill Announces New U.S. Coronavirus Patent for Opaganib, Valid Through 2041

RedHill Biopharma Ltd. announced the issuance of a new U.S. patent for identifying a novel biomarker of coronavirus pneumonia, prognostic for the efficacy of their drug opaganib in treating COVID-19. The patent is valid through 2041. Post-hoc data from a Phase 2/3 study showed that patients with ≤60% FiO2 levels had significantly better outcomes with opaganib treatment compared to placebo, including reduced need for supplemental oxygen, lower intubation rates, and decreased mortality. Opaganib, a host-directed drug, is being developed for multiple indications, including oncology and viral infections, with several U.S. government collaborations. The patent strengthens RedHills portfolio and supports its ongoing development efforts.

CustomersPartners

Sep 9, 2024 ·

growth-positive

RedHill's Talicia® Listed as First-Line Choice for H. pylori in New American College of Gastroenterology Guidelines

RedHill Biopharma Ltd. announced that Talicia, its low-dose rifabutin-triple therapy, has been listed as an empirically prescribed first-line option for the treatment of Helicobacter pylori (H. pylori) infection in the newly updated American College of Gastroenterology (ACG) Clinical Guideline. This update, the first since 2017, highlights Talicias minimal resistance rates and simplified patient experience. Talicia is now the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori infection, which affects approximately 35% of the U.S. adult population. The update is expected to improve patient outcomes and solidify Talicias market position.

Customers

Sep 5, 2024 ·

growth-positive

/PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received...

RedHill Biopharma Ltd. announced that it has regained compliance with the Nasdaq minimum bid price requirement, ensuring its continued listing on the Nasdaq Capital Market. The company achieved this by maintaining a minimum closing bid price of $1.00 per share for at least 10 consecutive business days, which was confirmed on September 3, 2024. RedHill focuses on gastrointestinal and infectious diseases and has several late-stage development programs, including treatments for COVID-19 and other conditions. The company promotes drugs like Talicia® and Aemcolo® and is involved in various clinical trials for new therapies.

Public Trading

Sep 5, 2024 ·

growth-positive

RedHill Biopharma Regains Compliance with Nasdaq Minimum Bid Price Requirement

RedHill Biopharma Ltd. announced that it has regained compliance with the Nasdaq minimum bid price requirement, ensuring its continued listing on the Nasdaq Capital Market. The company achieved this by maintaining a minimum closing bid price of $1.00 per share for at least 10 consecutive business days, as of September 3, 2024. RedHill focuses on gastrointestinal and infectious diseases, promoting drugs like Talicia® and Aemcolo®. The company is also involved in late-stage development programs for various treatments, including COVID-19 and cancer. This compliance is a positive development for RedHill, ensuring its stability in public trading.

Public Trading

Sep 3, 2024 ·

growth-positive

New Peer-Reviewed Publication of Opaganib Phase 2/3 Data Shows 62% Reduction in COVID-19 Mortality

RedHill Biopharma Ltd. announced the publication of data from a phase 2/3 study of opaganib in COVID-19 pneumonia, showing a 62% reduction in mortality and a 21% improvement in time to room air. The study, involving 251 hospitalized patients, suggests that FiO2 levels greater than 60% could serve as a biomarker for disease severity. The findings, published in the journal Microorganisms, highlight opaganibs potential as an effective oral therapy for COVID-19. The drug has demonstrated safety and efficacy in various indications, including oncology and viral infections, and is being evaluated by U.S. government programs for other uses.

CustomersPartners

Aug 29, 2024 ·

growth-positive

RedHill Biopharma Announces First Half 2024 Business Highlights

RedHill Biopharma Ltd. reported its financial results for the first half of 2024, highlighting significant cost-cutting measures and a strengthened cash balance. The company has streamlined its U.S. commercial organization, resulting in reduced expenses and a smaller, more efficient team. RedHills pipeline, including opaganib and RHB-107, is advancing through U.S. government-supported programs targeting multiple indications. The company also signed a Global Termination Agreement with Movantik Acquisition Co., resulting in a net balance sheet reduction. Despite a decrease in net revenues and gross profit, the cost-cutting measures have positively impacted the companys financial health.

CustomersPartnersInvestmentLayoffs

Aug 29, 2024 ·

growth-positive

A transformed RedHill: Numerous potential catalysts Strengthened cash balance and control over our destiny following the Termination Agreement with Movantik...

RedHill Biopharma Ltd. reported its financial results for the first half of 2024, highlighting a strengthened cash balance and operational efficiency following a Termination Agreement with Movantik Acquisition Co. The company has focused on cost-cutting measures, resulting in a smaller, more efficient U.S. commercial organization. RedHills pipeline, including opaganib and RHB-107, is advancing through U.S. government-supported programs targeting multiple indications. Despite a decrease in net revenues and gross profit, the company has reduced its operating loss and net loss due to significant cost-cutting measures. RedHills Talicia remains the leading prescribed branded H. pylori therapy in the U.S.

CustomersPartnersInvestmentLayoffs

Aug 26, 2024 ·

growth-positive

RedHill's Opaganib Granted Orphan Drug Designation by the FDA for Childhood Cancer, Neuroblastoma

RedHill Biopharma Ltd. announced that the FDA has granted orphan-drug designation to its drug opaganib for the treatment of neuroblastoma, a type of childhood cancer. This designation provides a seven-year marketing exclusivity period upon approval and may offer additional benefits such as accelerated development and review times, potential grant funding, and tax credits. This is the second orphan-drug designation for opaganib, following its previous designation for cholangiocarcinoma. The neuroblastoma market is expected to reach $1.5 billion before the mid-2030s. Opaganib is being developed for multiple indications, including oncology, viral, and inflammatory diseases.

CustomersPartners

Aug 21, 2024 ·

growth-positive

Talicia® Launched in the United Arab Emirates

RedHill Biopharma Ltd. has announced the launch of its H. pylori treatment, Talicia, in the United Arab Emirates (UAE). The commercial launch of Talicia in the UAE triggers RedHills eligibility for additional potential milestone payments, minimum sales payments, and tiered royalties on net sales. Talicia is the first approved low-dose rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori, a bacterial infection that affects 41% of the UAE population and over 50% of the worlds adult population.

CustomersExpand

Aug 21, 2024 ·

growth-positive

Three Undiscovered Gems in the United States Market

The article discusses the strong fundamentals and growth potential of three companies: Helport AI, RedHill Biopharma, and Hovnanian Enterprises. Helport AI, an AI technology company, has shown impressive growth with earnings increasing by 208% over the past year. RedHill Biopharma, a specialty biopharmaceutical company, recently reported a significant one-off gain of US$54.6M for the year ending December 31, 2023. Hovnanian Enterprises, a homebuilding company, has shown promising performance, with earnings growing by 20.3% over the past year. All three companies are considered undiscovered gems with strong fundamentals in the US market.

InvestmentPublic Trading

Aug 19, 2024 ·

Neutral

Upcoming Stock Splits This Week (August 19 to August 23) – Stay Invested

Several companies including Surf Air Mobility, Better Home Finance Holding Company, SITE Centers, Faraday Future Intelligent Electric, Aligos Therapeutics, Gingko Bioworks Holdings, RedHill Biopharma, Cadrenal Therapeutics, and ENDRA Life Sciences have announced stock splits and reverse stock splits. These actions are taken to comply with the NYSE and Nasdaqs minimum bid price requirements for continued listing. The splits will increase the number of outstanding shares, decrease the stock price, and maintain the market capitalization. Reverse splits will reduce the number of outstanding shares and increase the stock price while maintaining the market cap.

Public Trading

Aug 19, 2024 ·

growth-positive

RedHill Announces Positive Obesity and Diabetes Results with Opaganib

RedHill Biopharma Ltd. announced positive results from multiple in vivo studies, undertaken by RedHills partner, Apogee Biotechnology Corporation, showing the impact of opaganib on weight gain and glucose tolerance in a high fat diet (HFD) model. This supports the potential clinical use of opaganib for the prevention and therapy of Type 2 diabetes and other obesity-related disorders. The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034.

InvestmentPartners

Aug 16, 2024 ·

Neutral

RedHill Biopharma Announces Plan to Implement ADS Ratio Change

RedHill Biopharma Ltd. announced a ratio change of the Companys American Depositary Shares (ADSs) to its non-traded ordinary shares. The change is expected to take effect on or about August 20, 2024. The ratio change will have the same effect as a one-for-25 reverse ADS split. The company anticipates that after the ratio change, the price of its ADSs will increase proportionally and meet the Nasdaq minimum bid price requirement. RedHill Biopharma is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.

Public TradingManagement Changes

Aug 1, 2024 ·

growth-positive

Newly Published Positive Phase 3 Data Demonstrates 64% Increased Efficacy with RedHill's RHB-104 in Crohn's Disease

RedHill Biopharma Ltd. has announced positive data from a Phase 3 clinical trial of its orally administered RHB-104 plus standard of care (SoC) treatment for Crohns disease. The data shows that the treatment was 64% more effective than SoC alone, supporting the hypothesis of a Mycobacterial basis to the disease. The study was conducted across more than 100 sites and involved 331 patients. The Crohns disease market was valued at more than $13 billion in 2023.

InvestmentExpand

Jul 22, 2024 ·

growth-positive

RedHill Biopharma Strengthens Cash Balance, Settles Obligations and Removes Talicia® Lien

RedHill Biopharma has announced the signing of a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, and HCR Redhill SPV. The agreement has resulted in RedHill receiving approximately $9.9 million in cash and gaining full control over an additional $0.74 million currently held in a restricted account. This has led to an increase of approximately $12.2 million in liabilities for RedHill, reflecting assumed and settled liabilities between the parties, and a net balance sheet reduction of approximately $2.3 million. The agreement also ends all existing credit ties with the Agreement parties, removes the existing lien against Talicia and restores control over cash collections back to RedHill.

Partners

Jul 9, 2024 ·

Growth-Negative

RedHill Biopharma Terminates License Agreement for Aemcolo®

RedHill Biopharma Ltd. and Cosmo Technologies Ltd. have mutually decided to terminate their exclusive U.S. license agreement for Aemcolo, a treatment for travelers diarrhea. The agreement, initially dated October 17, 2019, will officially end on October 8, 2024. Following the termination, RedHill will cease any Aemcolo commercialization, and all rights previously ascribed to RedHill in the agreement will revert to Cosmo.

Partners

Jun 3, 2024 ·

growth-positive

RedHill Announces a New Patent Covering Opaganib in Combination with Immune Checkpoint Inhibitors, Valid Through 2040

RedHill Biopharma Ltd. has announced the issue of a new Chinese patent notice of allowance for opaganib in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response. The patent provides protection for opaganibs potential use with a range of approved and in-development ICIs across a growing range of indications through 2040. Opaganib is a host-directed and potentially broad-acting twice-daily oral, small molecule with a demonstrated safety & efficacy profile, and is in development for multiple oncology, viral and inflammatory indications.

Investment

May 22, 2024 ·

uk.finance.yahoo.com

growth-negative

Pensioners win £9,000 back in 16-year council tax battle

Residents of a retirement village in Redhill, Surrey, have won a 16-year battle over incorrect council tax bills. The Valuation Office Agency (VOA) had wrongly placed 113 residents’ homes in higher council tax bands, leading to overcharges. The error dates back to 1993 and residents are now receiving rebates of up to £9,000 each. The issue was first raised in 2008 but was rejected by the VOA. It was only in 2022, when residents discovered they could not apply for energy bill support due to the incorrect banding, that the issue was revisited and finally resolved.

Customers

May 6, 2024 ·

growth-positive

RedHill Announces New Opaganib Chinese Patent Against Ebola Virus Valid Through 2035

RedHill Biopharma Ltd. has announced the issue of a new Chinese patent for opaganib, a therapy for inhibition of single-stranded RNA virus replication, notably Ebola Disease Virus. The patent is valid through 2035 and adds to opaganibs strong global intellectual property portfolio across multiple indications. U.S. Army studies suggest that opaganib may be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival. The drug is in development for multiple indications, including COVID-19, acute respiratory distress syndrome, oncology and two U.S. government-sponsored countermeasures programs for Acute Radiation Syndrome and Sulfur Mustard exposure.

Investment

Apr 24, 2024 ·

growth-positive

RedHill Announces First Patient Enrolled in U.S. Government-Supported COVID-19 Study

RedHill Biopharma Ltd. has announced the enrollment of the first patient in a global, 300-patient, Phase 2 adaptive platform trial for RHB-107 (upamostat) for early COVID-19 outpatient treatment. The trial is funded through non-dilutive external sources, including the U.S. Department of Defense, and is expected to be completed by the end of 2024. RHB-107 has shown promising efficacy results, including a significant reduction in hospitalization due to COVID-19 in a U.S. Phase 2 study. The drug is a novel, oral, once-daily, host-directed potential broad-acting antiviral expected to act independently of viral spike protein mutations.

InvestmentPartners

Apr 10, 2024 ·

growth-positive

RedHill Biopharma Full Year 2023 Earnings: EPS: US$4.00 (vs US$46.29 loss in FY 2022)

RedHill Biopharma has reported its full year 2023 results, with a net income of US$23.9m, a significant increase from the US$71.7m loss in FY 2022. The companys earnings per share (EPS) also increased to US$4.00, up from a loss of US$46.29 in FY 2022. Despite these positive results, RedHill Biopharmas shares are down 6.0% from a week ago. The article also mentions that there are 3 warning signs for RedHill Biopharma that potential investors should be aware of.

Public Trading

Apr 8, 2024 ·

growth-positive

RedHill Biopharma Announces Full-Year 2023 Results and Operational Highlights

RedHill Biopharma Ltd. reported its full year 2023 financial results, with a net income of $23.9 million compared to a net loss of $71.7 million in 2022. The companys cash balance as of December 31, 2023, was $6.5 million. RedHills R&D efforts are focused on its two lead investigational candidates, opaganib and RHB-107, which are advancing in programs that are externally funded, predominantly through U.S. government support. The company is also in discussions with multiple parties regarding strategic business transactions, including potential divestment of certain assets and/or commercial operations.

InvestmentExpand

Apr 2, 2024 ·

growth-positive

RedHill Biopharma Announces $1.25 Million Registered Direct Offering at a Premium to Market Price

RedHill Biopharma Ltd. has entered into definitive agreements with private investors for the purchase and sale of 2,144,487 of the Companys American Depositary Shares (ADSs) and warrants to purchase up to an aggregate of 2,144,487ADSs. The gross proceeds to the Company from the offering are expected to be $1.25 million, before deducting offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for general corporate purposes and working capital.

Investment

Mar 11, 2024 ·

growth-positive

RedHill Announces New USPTO Patent Covering Talicia® Through 2034

RedHill Biopharma Ltd. has announced that the U.S. Patent and Trademark Office (USPTO) has issued a new patent for Talicia, an all-in-one treatment for Helicobacter pylori (H. pylori) infection. This patent is expected to provide protection for Talicia until February 12, 2034. Talicia is the only FDA-approved rifabutin-containing all-in-one therapy for the eradication of H. pylori. The new patent adds to the existing strong intellectual property portfolio protecting Talicia, including composition of matter and other patents and FDA-granted data exclusivities.

Investment

Mar 5, 2024 ·

growth-positive

RedHill's Opaganib Selected for Evaluation by BARDA and NIH Countermeasures Programs

RedHill Biopharma Ltd., in partnership with Apogee Biotechnology Corporation, has announced that their drug, opaganib, has been selected by the U.S. governments Chemical Medical Countermeasures (Chem MCM) Program and Chemical Countermeasures Research Program (CCRP) for evaluation as a potential medical countermeasure against inhalation Sulfur Mustard exposure. The evaluation will also assess opaganibs efficacy against sub-chronic fibrosis and acute respiratory distress syndrome (ARDS) resulting from Sulfur Mustard exposure. Opaganib is a novel oral small molecule and the first sphingosine kinase-2 (SPHK2) inhibitor investigational drug targeting sphingolipid metabolism to be evaluated as a chemical countermeasure.

Partners

Feb 20, 2024 ·

growth-positive

RedHill's Opaganib Protects Against Radiation-Induced Lung Inflammation and Fibrosis - New Publication

RedHill Biopharma Ltd. has announced new data showing that its investigational drug opaganib significantly improved long-term survival in a model of lung damage following exposure to ionizing radiation. The data, published in the International Journal of Molecular Sciences, supports the potential use of opaganib as a medical countermeasure against nuclear irradiation and in cancer radiotherapy. Opaganib is being tested as a potential treatment for Acute Radiation Syndrome (ARS) following selection by the U.S government National Institutes of Healths (NIH) Radiation and Nuclear Countermeasures Program (RNCP).

InvestmentPartners

Jan 26, 2024 ·

growth-positive

RedHill Biopharma Announces Closing of $8 Million Registered Direct Offering

RedHill Biopharma Ltd. has closed a registered direct offering for the purchase and sale of 10,000,000 of the Companys American Depositary Shares (ADSs) at a purchase price of $0.80 per ADS. In a concurrent private placement, the Company issued unregistered warrants to purchase up to 10,000,000 ADSs. The gross proceeds from the offering were $8 million. The Company intends to use the net proceeds from the offering for general working capital, acquisitions, research and development, and general corporate purposes.

Investment

Jan 25, 2024 ·

growth-positive

RedHill Announces New USPTO Patent Grant for Talicia® for H. pylori Treatment Through 2042

RedHill Biopharma Ltd. has been granted a new patent by the U.S. Patent and Trademark Office (USPTO) for its drug, Talicia. The patent covers Talicia as a method for eradicating H. pylori regardless of a patients Body Mass Index (BMI). The patent is expected to provide protection for Talicia until May 2042. The U.S. FDA has also granted five years market exclusivity for Talicia under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation. Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for eradication of H. pylori.

Customers

Jan 25, 2024 ·

growth-positive

RedHill Biopharma Announces $8 Million Registered Direct Offering

RedHill Biopharma Ltd. has announced definitive agreements with institutional investors for the purchase and sale of 10,000,000 of the Companys American Depositary Shares (ADSs) at a purchase price of $0.80 per ADS. In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 10,000,000 ADSs. The gross proceeds to the Company from the offering are expected to be $8 million. The Company intends to use the net proceeds from the offering for general working capital, acquisitions, research and development, and general corporate purposes. The closing of the offering is expected to occur on January 29, 2024.

Investment

Dec 20, 2023 ·

growth-positive

RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola

RedHill Biopharmas investigational drugs, opaganib and RHB-107, have shown a synergistic effect when combined with remdesivir in a U.S. Army-funded in vitro Ebola virus study. The drugs, which are also effective against COVID-19, significantly improved potency while maintaining cell viability. Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease. RHB-107 has recently been accepted for inclusion in the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment. The study is expected to be completed by the end of 2024.

Investment

Dec 12, 2023 ·

growth-positive

RedHill Biopharma Regains Compliance with Nasdaq Minimum Bid Price Requirement

RedHill Biopharma Ltd. has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) for continued Nasdaq listing. The company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved on December 8, 2023. Previously, the company had received notification that for the previous thirty consecutive business days, the bid price for the American Depositary Shares had closed below the minimum $1.00 per share requirement for continued listing.

Public Trading

Dec 4, 2023 ·

growth-positive

RedHill Announces New, Non-Dilutive External Funding of Entire RHB-107 COVID-19 300-Patient Phase 2 Study

RedHill Biopharma Ltd. has announced new non-dilutive external funding, in addition to previously announced U.S. Government funding, which now covers the entirety of the RHB-107 arm of the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment. This additional funding amounts to approximately $4.8M. The 300-patient Phase 2 RHB-107 arm of the PROTECT study has received FDA clearance to start, with the first patient expected to be enrolled in the coming weeks. The study is being conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by end of 2024.

Investment

Dec 4, 2023 ·

growth-positive

RedHill Announces New, Non-Dilutive External Funding of Entire RHB-107 COVID-19 300-Patient Phase 2 Study

RedHill Biopharma Ltd. has received new non-dilutive external funding, in addition to previously announced U.S. Government funding, to cover the entirety of the RHB-107 arm of the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment. The additional funding amounts to approximately $4.8M. The 300-patient Phase 2 RHB-107 arm of the PROTECT study has received FDA clearance to start, with the first patient expected to be enrolled in the coming weeks. The study is being conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by end of 2024.

Investment

Nov 27, 2023 ·

growth-positive

RedHill Biopharma Announces FDA Grant of 5-Year U.S. Market Exclusivity for Talicia® with IP Protection Running to 2034

RedHill Biopharma Ltd. has been granted five years market exclusivity for Talicia, a therapy for H. pylori infection, under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA. This is in addition to three years exclusivity previously granted for the approval of Talicia. The drug is protected by its broad intellectual property suite until 2034. Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population.

Investment

Nov 14, 2023 ·

growth-negative

RedHill Biopharma Announces the Transfer of its Listing to The Nasdaq Capital Market

RedHill Biopharma Ltd. has announced that it has received approval from the Listing Qualifications Department of The Nasdaq Stock Market LLC to transfer the listing of the American Depositary Shares (ADSs) to the Nasdaq Capital Market. The company had received a delisting notification from Nasdaq due to non-compliance with the minimum Market Value of Publicly Held Shares (MVPHS) requirement. The transfer will take place on November 15, 2023. The company also received a letter from Nasdaq indicating that the bid price of the ADSs had closed at less than $1.00 per share over the previous 30 consecutive business days, and, as a result, it did not comply with Listing Rule 5450(a)(1).

Public Trading

Oct 3, 2023 ·

growth-positive

RedHill and U.S. Army Announce Opaganib's Ebola Virus Disease Survival Benefit in U.S. Army-Funded In-Vivo Study

RedHill Biopharma Ltd. has announced that its novel oral drug, opaganib, has shown a significant increase in survival time in a U.S. Army-funded in vivo Ebola virus study. Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease. The drug has previously demonstrated antiviral benefits in late-stage clinical studies of patients hospitalized with moderate to severe COVID-19. The U.S. Army study tested three doses of opaganib against an inactive vehicle control arm, with the results showing a statistically significant survival increase in the opaganib group.

Investment

Sep 22, 2023 ·

growth-negative

RedHill Biopharma Announces Receipt of Nasdaq Notification Regarding Minimum Bid Price Deficiency

RedHill Biopharma Ltd. has received a letter from the Listings Qualifications Department of The Nasdaq Stock Market LLC indicating that the bid price for the companys American Depositary Shares (ADSs) had closed below the minimum $1.00 per share requirement for continued listing on The Nasdaq Global Market. The company has been given an initial period of 180 calendar days, or until March 18, 2024, to regain compliance. If the company does not regain compliance by this date, it may be eligible for an additional 180 calendar day period to regain compliance.

Public Trading

Sep 18, 2023 ·

growth-positive

RedHill Announces FDA sNDA Approval for Talicia®

RedHill Biopharma Ltd. has announced the FDAs approval of its supplemental new drug application (sNDA) for Talicia, a treatment for H. pylori bacterial infection. The approval allows a change to a more flexible three times daily dosing regimen, which is expected to increase patient adherence and optimize the potential for successful H. pylori eradication. Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population.

CustomersPartners

Sep 5, 2023 ·

growth-positive

RedHill Announces New USPTO Notice of Patent Allowance for Opaganib and EU Patent Grant for RHB-102 (BEKINDA®)

RedHill Biopharma Ltd. has announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new opaganib patent, which covers sphingosine kinase 2 inhibition treatment for Ebola virus disease. This patent will provide protection for opaganib until October 2035. Additionally, the European Patent Office has granted a new RHB-102 patent, which covers ondansetron extended-release solid dosage forms for treating nausea, vomiting, or diarrhea symptoms. This patent is expected to provide protection for RHB-102 across multiple indications until March 2035.

Investment

Aug 17, 2023 ·

growth-positive

RedHill Biopharma Provides H1/23 Financial Results and Operational Highlights

RedHill Biopharma Ltd. has released its financial results for the first half of 2023, revealing a net income of $51 million, compared to a net loss of $32.2 million for the same period in 2022. The companys total assets as of June 30, 2023, were $35 million, compared to $158.9 million as of December 31, 2022. The decrease was primarily due to the divestiture of Movantik. The company is now debt-free and has a significantly reduced cost-base. Its two lead R&D candidates, RHB-107 and opaganib, are progressing their development in outpatient COVID-19 and Acute Radiation Syndrome, respectively, both supported extensively by U.S. government funding.

InvestmentManagement Changes

Aug 1, 2023 ·

growth-positive

RedHill Biopharma Announces Talicia Approved in the United Arab Emirates and First Commercial Order Outside the U.S.

RedHill Biopharmas partner, Gaelan Medical, has received marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia, a treatment for H. pylori. This approval makes Talicia the first approved rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori. Gaelan Medical has placed an initial order for Talicia and has begun commercialization activities. H. pylori is a major public health concern in the region, impacting up to 84% of the population.

PartnersExpand

Jul 31, 2023 ·

growth-positive

RedHill's RHB-107 Included in U.S. Government-Supported COVID-19 Platform Trial and Cleared for Initiation by FDA

RedHill Biopharmas RHB-107 (upamostat) has been accepted for inclusion in the ACESOs PROTECT adaptive platform trial for early COVID-19 outpatient treatment. The Phase 2 study, funded by the U.S. Government Department of Defenses JPEO-CBRND, has received FDA clearance to start in Q3 2023 and is estimated to be completed by end of 2024. The study will be conducted in the U.S., Thailand, Ivory Coast, and South Africa. RHB-107 is expected to target a multi-billion-dollar early COVID-19 treatment market. The drug has shown promising efficacy results, including a marked reduction in hospitalization due to COVID-19.

InvestmentPartners

Jul 25, 2023 ·

growth-positive

RedHill Biopharma Announces Closing of $3.8 Million Registered Direct Offering and Warrant Exercise

RedHill Biopharma Ltd. has closed its previously announced registered direct offering for the purchase and sale of 1,301,923 of the Companys American Depositary Shares (ADSs) at a purchase price of $1.35 per ADS. The gross proceeds to the Company from the transactions were approximately $3.8 million. The Company intends to use the net proceeds from these transactions for general working capital, acquisitions, research and development, and general corporate purposes.

Investment

Jul 21, 2023 ·

growth-positive

RedHill Announces Additional U.S. Government Funding for Opaganib Nuclear Countermeasure Development

RedHill Biopharma Ltd. has been awarded a further $1.7 million in U.S. Government funding for the development of opaganib, a potential medical countermeasure for gastrointestinal acute radiation syndrome (ARS). The funding comes via a Small Business Innovation Research (SBIR) grant to the companys development partner, Apogee Biotechnology Corporation. This is in addition to a multimillion-dollar contract from the U.S. Government Radiation and Nuclear Countermeasures Program (RNCP). Opaganib is being developed for multiple indications, including COVID-19, acute respiratory distress syndrome (ARDS), oncology, and additional indications.

InvestmentPartners

Jul 21, 2023 ·

growth-positive

RedHill Biopharma Announces Registered Direct Offering and Warrant Exercise for $3.8 Million Gross Proceeds

RedHill Biopharma Ltd. has announced definitive agreements with institutional investors for the purchase and sale of 1,301,923 of the Companys American Depositary Shares (ADSs) at a purchase price of $1.35 per ADS. The company also entered into an agreement with a holder of its existing Class A warrants exercisable for 1,500,000 ADSs, to exercise its warrants at a reduced exercise price of $1.35 per ADS. The transactions are expected to close on July 25, 2023, and the gross proceeds to the Company from the transactions are expected to be approximately $3.8 million.

Investment

Jun 12, 2023 ·

growth-positive

RedHill Biopharma Announces Q1/2023 Financial Results and Operational Highlights

RedHill Biopharma Ltd. reported its Q1 2023 financial results, with net revenues of $3.4 million and a cash balance of $28.8 million. The company extinguished all debt obligations in exchange for the transfer of rights in Movantik, resulting in a net income of $50.2 million for Q1 2023. The companys CEO, Dror Ben-Asher, stated that 2023 has begun with a clear focus on maximizing Talicia and potentially securing additional revenue-generating products. The company also announced that it had received a notification from Nasdaq indicating that it is not in compliance with the minimum Market Value of Publicly Held Shares for continued Nasdaq listing. The company has until November 6, 2023, to regain compliance.

InvestmentManagement Changes

May 22, 2023 ·

growth-negative

RedHill Provides R&D Update

RedHill Biopharma has decided to terminate the U.S. Phase 3 study of RHB-204 for Non-tuberculosis Mycobacteria (NTM) disease due to a low accrual rate. The company plans to reallocate resources to advance the late-stage development of RHB-107 for outpatient treatment of COVID-19. The decision is intended to allow the company to focus on key pipeline catalysts and revenue-generating product acquisition, while seeking out-licensing partners for RHB-204. RedHills advanced pipeline also includes Opaganib, developed in collaboration with the U.S. Governments Radiation and Nuclear Countermeasures Program, and RHB-102, which is potentially up for UK marketing approval for oncology support.

Management Changes

May 15, 2023 ·

Growth-Negative

RedHill Biopharma Receives NASDAQ Notification Regarding Minimum Market Value of Publicly Held Shares Deficiency

RedHill Biopharma Ltd. has received a notification from the Nasdaq Stock Market indicating that the company is not in compliance with the minimum Market Value of Publicly Held Shares (MVPHS) set forth in the Nasdaq Rules for continued listing. The company has a compliance period of 180 calendar days to regain compliance. If the company does not regain compliance before the expiration of the compliance period, it may receive a notification that its securities are subject to delisting.

Public Trading

May 9, 2023 ·

growth-positive

RedHill Publishes New Talicia® Data on Generic Non-Bioequivalence in AP&T and Presents New Dosing Data at Digestive Disease Week

RedHill Biopharma Ltd. has announced new data on its Talicia therapy for H. pylori eradication. The data, published in the Alimentary Pharmacology and Therapeutics Journal and presented at Digestive Disease Week, showed that generically substituted regimens are non-bioequivalent to Talicia. The data also supports bioequivalence between Talicia TID (three times daily) and Q8H (every eight hours) dosing regimens for H. pylori eradication therapy. These findings support Talicias position as the leading prescribed branded H. pylori therapy by U.S. gastroenterologists.

Customers

May 1, 2023 ·

growth-positive

RedHill's RHB-102 (BEKINDA®) and Opaganib Granted New Patents in Oncology Setting

RedHill Biopharma Ltd. has been granted two new patents in the EU and U.S. for RHB-102 (BEKINDA) and opaganib, respectively, in the oncology setting. The European Patent Office granted a patent for RHB-102, a drug for the prevention of nausea and vomiting (CINV/RINV), providing potential UK and EU protection until March 2034. The U.S. Patent and Trademark Office has granted a new patent for opaganib for the treatment of cancer, extending protection until October 2036. The company is in discussions with potential commercialization partners in the UK and other territories.

Partners

Apr 28, 2023 ·

growth-positive

RedHill Biopharma Announces Q4/22 & Full-Year 2022 Results and Operational Highlights

RedHill Biopharma Ltd. has reported its Q4 and full year 2022 financial results, highlighting the extinguishment of all debt and a focus on late-stage pipeline advancement. The company reported a cash balance of $36.1 million as of December 31, 2022 and a reduced operating loss of $9.9 million in Q4/22, compared to $20.7 million in Q4/21. The company also reported a year-over-year prescription growth of 57% for its product, Talicia. RedHill is now focused on commercial growth and revenue-generating product acquisition opportunities.

InvestmentExpand

Apr 17, 2023 ·

growth-negative

Benign Growth For RedHill Biopharma Ltd. (NASDAQ:RDHL) Underpins Stock's 41% Plummet

RedHill Biopharma Ltd.s shares have dropped by 41% in the last month, completing a 96% loss for shareholders over the past year. Despite this, the companys price-to-sales (P/S) ratio of 0.2x could be seen as bullish, as half of all companies in the US pharmaceuticals industry have P/S ratios greater than 3.1x. However, RedHills revenue has been declining, and it is expected to continue to decline by 22% each year over the next three years. This weak outlook is likely to continue to weigh down the shares.

Customers

Apr 11, 2023 ·

growth-positive

RedHill Biopharma Regains Compliance with Nasdaq Minimum Bid Price Requirement

RedHill Biopharma Ltd., a specialty biopharmaceutical company, has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) for continued Nasdaq listing. The company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved on April 5, 2023. Previously, the company had received notification that the bid price for the American Depositary Shares had closed below the minimum $1.00 per share requirement for continued listing.

Public Trading

Apr 3, 2023 ·

growth-positive

RedHill Biopharma Announces Closing of $6 Million Registered Direct Offering

RedHill Biopharma Ltd. has closed its previously announced registered direct offering for the purchase and sale of 1,500,000 of the Companys American Depositary Shares (ADSs), series A warrants to purchase up to an aggregate of 1,500,000 ADSs and series B warrants to purchase up to an aggregate of 1,500,000 ADSs. The gross proceeds to the Company from this offering were $6 million. The Company intends to use the net proceeds from this offering for general working capital, acquisitions, research and development, and general corporate purposes.

Investment

Mar 30, 2023 ·

growth-positive

RedHill Biopharma Announces $6 Million Registered Direct Offering

RedHill Biopharma Ltd. has announced a definitive agreement for the purchase and sale of 1,500,000 of the Companys American Depositary Shares (ADSs) and associated warrants in a registered direct offering. The gross proceeds from this offering are expected to be $6 million, before deducting the placement agents fees and other offering expenses. The company plans to use the net proceeds for general working capital, acquisitions, research and development, and general corporate purposes. The closing of the offering is expected to occur on or about April 3, 2023.

Investment

Mar 23, 2023 ·

growth-negative

RedHill Biopharma Ltd.'s (NASDAQ:RDHL) market cap dropped US$146m last week; Individual investors bore the brunt

RedHill Biopharma Ltd. has a diverse ownership structure with individual investors holding the maximum shares at 49%. The top 14 shareholders control 50% of the business. Institutional investors also have a significant stake in the company, with hedge funds controlling 32% of the shares. Empery Asset Management, LP is the largest shareholder with 23% of shares. Private companies own 4.3% and public companies own 7.6% of RedHill Biopharma. However, the stock fell by 22% last week, causing significant losses for individual investors.

CustomersInvestment

Mar 21, 2023 ·

growth-positive

RedHill Initiates First Community-Setting Warranty Program to Refund Talicia Non-Responders

RedHill Biopharma Ltd. has announced a warranty program for its H. pylori eradication therapy, Talicia. The program will reimburse patient out-of-pocket costs if Talicia does not work. This commitment extends to all commercially insured and non-insured Talicia patients who complete the full 14-day treatment course and whose infection is not eradicated based on post-treatment confirmation testing. Talicia is the most prescribed branded agent by gastroenterologists for H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population.

Customers

Mar 16, 2023 ·

Neutral

RedHill Biopharma Announces Plan to Implement ADS Ratio Change

RedHill Biopharma Ltd. plans to implement a ratio change of the Companys American Depositary Shares (ADSs) to its non-traded ordinary shares. The anticipated first date of the ratio change is on or about March 23, 2023. The companys ADSs will continue to be traded on the Nasdaq Global Market under the symbol RDHL. The ratio change will have the same effect as a one-for-forty reverse ADS split. The company anticipates that after the ratio change, the price of its ADS will increase proportionally and meet the Nasdaq minimum bid price requirement.

Public TradingManagement Changes

Mar 9, 2023 ·

growth-positive

RedHill Biopharma Announces Definitive Agreement for Up To $6 Million Private Placement with a Single Investor

RedHill Biopharma Ltd. has announced an agreement with a single investor for the issuance of a convertible promissory note of up to $6 million. The funds raised will be used for general working capital, acquisitions, research and development, and general corporate purposes. The promissory note will be issued in three tranches of $2 million, $1 million, and $3 million respectively. The note has a one-year term and must be converted by the end of the term.

Investment

Feb 28, 2023 ·

growth-positive

RedHill Biopharma Ltd Announces RDHL Opaganib Selected by NIH RNCP For Development

RedHill Biopharmas drug, Opaganib, has been selected by the National Institutes of Healths (NIH) Radiation and Nuclear Countermeasures Program (RNCP) for testing as a potential treatment for Acute Radiation Syndrome (ARS). The collaboration with RNCP is expected to significantly accelerate the development of Opaganib, providing access to key research models and resources. This follows recent guidance from the U.S Food and Drug Administration (FDA) to RedHill about the applicability of the Animal Rule regulatory pathway for Opaganib for ARS. RedHill will work closely with the RNCP on the development of Opaganib as a potential radiation medical countermeasure.

Partners

Feb 28, 2023 ·

growth-positive

RedHill's Opaganib Selected by the NIH Radiation and Nuclear Countermeasures Program

RedHill Biopharmas drug, opaganib, has been selected by the National Institutes of Healths (NIH) Radiation and Nuclear Countermeasures Program (RNCP) for testing as a potential treatment for Acute Radiation Syndrome (ARS). The RNCP aims to accelerate the development of medical countermeasures for radiation injuries. The collaboration with RedHill will involve studies to validate opaganibs efficacy in pre-clinical animal models of ARS. The company expects the collaboration to significantly accelerate the development of opaganib. The selection follows recent FDA guidance to RedHill about the applicability of the Animal Rule regulatory pathway for opaganib for ARS.

Partners

Feb 16, 2023 ·

growth-positive

RedHill Biopharma Ltd Announces RedHill's RHB-102 Positive MHRA Meeting & MAA Plan

RedHill Biopharma Ltd has announced plans to submit a Marketing Authorisation Application (MAA) to the UK Medicines & Healthcare products Regulatory Agency (MHRA) for its drug RHB-102 (Bekinda) for oncology support. The drug is used for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy in adults and children over the age of 12. The decision follows a positive pre-MAA meeting with the MHRA. If approved, RHB-102 could become the first oral 24hr extended-release 5-HT3 antiemetic drug in the UK indicated for the treatment of chemotherapy and radiotherapy induced nausea and vomiting.

InvestmentExpand

Feb 16, 2023 ·

growth-positive

RedHill Announces Positive MHRA Meeting and Planned UK Marketing Authorisation Application of RHB-102 (BEKINDA®) for Oncology Support

RedHill Biopharma Ltd. has announced plans to submit a Marketing Authorisation Application (MAA) to the UK Medicines & Healthcare products Regulatory Agency (MHRA) for RHB-102 (Bekinda) for oncology support in adults and children over the age of 12. The drug is intended to manage nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy (CINV and RINV). The global CINV/RINV market is estimated to be worth over $10 billion by 2031, with the UK market expected to grow at 6.4% CAGR, accounting for around 20% of the European market.

CustomersExpand

Feb 15, 2023 ·

growth-positive

RedHill Biopharma Announces Positive FDA Meeting Regarding Opaganib for Acute Nuclear Radiation Syndrome

RedHill Biopharma Ltd. has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding the development of its drug, opaganib, for Acute Radiation Syndrome (ARS). The FDA has provided guidance on opaganibs developmental pathway to potential approval under the Animal Rule, which allows for the use of pivotal animal model efficacy studies when human clinical trials are not ethical or feasible. Opaganib is a small molecule pill with a five-year shelf life that could be used for central stockpiling by governments against mass casualty nuclear radiation incidents. RedHill plans to work closely with the FDA and other U.S. agencies on the development of opaganib.

Partners

Feb 10, 2023 ·

Raleigh pharma sheds debt in exchange for top-selling drug. Now what?

Oct 26, 2022 ·

growth-positive

RedHill Presents New Talicia® and Movantik® Data Analyses at ACG 2022

RedHill Biopharma Ltd. has announced the presentation of new data analyses for Talicia, for the treatment of H. pylori, and Movantik, for the treatment of opioid-induced constipation, at the American College of Gastroenterology Annual Meeting. The study used Physiologically-Based Pharmacokinetic (PBPK) modeling to compare intragastric rifabutin concentrations with Talicia and generic rifabutin. The analysis indicates that Talicia provides favorable intragastric rifabutin concentration and as a result provides high potential for H. pylori eradication while minimizing systemic antibiotic exposure. The two Movantik posters are pooled analyses of two phase 3 clinical studies of Movantik in patients with OIC and assess the impact of Movantik on patient quality of life.

CustomersInvestment

May 9, 2022 ·

growth-positive

RedHill Biopharma Announces $15 Million Registered Direct Offering with a Leading Healthcare Investor

RedHill Biopharma Ltd. has entered into an agreement with a leading healthcare investor for the purchase and sale of over 10 million of the companys American Depositary Shares (ADSs) at a purchase price of $1.42 per ADS. RedHill will also issue to the investor unregistered private warrants to purchase up to an aggregate of over 13 million ADSs in a concurrent private placement. The gross proceeds from this offering are expected to be approximately $15 million. The company intends to use the net proceeds for working capital, acquisitions, and general corporate purposes.

Investment

Apr 11, 2022 ·

www.benzinga.com

growth-positive

RedHill Biopharma Says Opaganib Can Potentially Work Against COVID-19 Omicron Subvariants - Redhill Biopharma (NASDAQ:RDHL)

RedHill Biopharmas drug candidate, opaganib, has shown potent in vitro efficacy against the omicron variant of COVID-19. The drug improved the median time to viral RNA clearance by at least 4 days in a Phase 2/3 study. Additional analyses also showed a 70% reduction in mortality and a 34% benefit in time to recovery for patients treated with opaganib. Regulatory submissions and discussions are ongoing in the U.S., Europe, the U.K., and other countries.

Customers

Mar 1, 2022 ·

www.eurekalert.org

growth-positive

RedHill announces positive phase 2 study results with oral RHB-107 in non-hospitalized COVID-19

RedHill Biopharma has announced positive results from the Phase 2 part of the Phase 2/3 study of RHB-107, an oral treatment for symptomatic COVID-19 patients. The study showed a 100% reduction in hospitalization due to COVID-19, with zero patients on RHB-107 hospitalized compared to 15% on the placebo-controlled arm. The study also showed an 87.8% reduction in reported new severe COVID-19 symptoms. The study met its primary outcome measure, demonstrating a favorable safety and tolerability profile of RHB-107.

Investment

Jan 6, 2022 ·

growth-positive

RedHill Biopharma and Gaelan Medical Enter Into License Agreement for Talicia® for the United Arab Emirates

RedHill Biopharma has entered into an exclusive license agreement with Gaelan Medical Trade, a subsidiary of the Ghassan Aboud Group, for its H. pylori therapy, Talicia, in the United Arab Emirates. Under the agreement, RedHill will receive an upfront payment of $2 million and is eligible for additional milestone payments and tiered royalties on net sales of Talicia in the UAE. Gaelan Medical will receive the exclusive rights to commercialize Talicia in the UAE, and a right of first refusal to commercialize Talicia in the Gulf Cooperation Council region.

PartnersInvestment

Nov 18, 2021 ·

Growth-Positive

RedHill Biopharma Announces Underwritten Public Offering of American Depositary Shares

RedHill Biopharma Ltd. has announced an underwritten public offering of American Depositary Shares (ADSs), with each ADS representing ten ordinary shares of the company. The offering will be managed by Cantor Fitzgerald & Co. The net proceeds from the offering will be used to fund RedHills commercialization activities, clinical development programs, acquisitions, and general corporate purposes. The securities will be offered pursuant to a shelf registration statement declared effective by the Securities and Exchange Commission in August 2019.

Public TradingInvestment

Sep 14, 2021 ·

growth-negative

RedHill Biopharma Reports Top-Line Data from Opaganib Phase 2/3 Study in Severe COVID-19 Patients

RedHill Biopharma announced preliminary top-line data from a global Phase 2/3 study with opaganib in hospitalized patients with severe COVID-19 pneumonia. The study did not meet its primary endpoint, but analysis showed trends in favor of the opaganib arm. Despite not achieving statistical significance, the findings could support the potential utilization of opaganib in earlier stages of the disease. RedHill intends to discuss the data with regulators, including the U.S. FDA and foreign regulators, to help determine next steps.

Customers

Feb 28, 2021 ·

growth-positive

Israel's RedHill Biopharma testing oral pill that cures Covid-19 symptoms

Israeli pharmaceutical company, RedHill Biopharma, is testing a new treatment for Covid-19 induced respiratory symptoms. The treatment, an oral pill named Opaganib, is designed to treat severe breathing-related symptoms caused by the coronavirus. The company is also developing another treatment, RHB-107, which aims to treat Covid-19 symptoms. The companys drug can be orally administered, making it less invasive for patients. The company, which is listed on the Nasdaq, generates $90 million in sales annually from its three FDA-approved products.

CustomersPublic Trading

Dec 15, 2020 ·

growth-positive

RedHill's Phase 2/3 COVID-19 Candidate Opaganib Reduces ARDS-Related Blood Clotting in Preclinical Model

RedHill Biopharma Ltd. announced promising preliminary results from a preclinical study of opaganib, a novel orally administered sphingosine kinase 2 (SK2) selective inhibitor, demonstrating a reduction of thrombosis (blood clotting) in an acute respiratory distress syndrome (ARDS) model. The study suggests opaganib could benefit COVID-19 patients by inhibiting SARS-CoV-2 replication and potentially reducing hyper immune-response. Top-line data from the U.S. Phase 2 study of opaganib in patients with severe COVID-19 is expected later this month, and data from a global Phase 2/3 study is expected in Q1/2021.

InvestmentExpand

Dec 2, 2020 ·

www.usnews.com

Coronavirus Pandemic Boosting Anti-Virus Research Around the World

Nov 26, 2020 ·

www.pharmanewsdaily.com

growth-positive

RedHill Biopharma expands manufacturing capacity of Covid-19 drug candidate opaganib in US - www.PharmaNewsDaily.com

RedHill Biopharma, an Israeli biopharma company, has announced partnerships with US-based manufacturers for large-scale production of its Covid-19 drug candidate, opaganib. This follows recent collaborations with European and Canadian manufacturers. The partnerships are part of RedHills preparations for potential emergency use applications for opaganib in the treatment of severe Covid-19 pneumonia, expected as early as Q1 2021. The company is also progressing with a global phase 2/3 trial with opaganib, with enrollment more than 50% complete.

PartnersExpand

Oct 14, 2020 ·

growth-positive

Israel's Redhill Biopharma signs manufacturing deal for potential Covid-19 treatment

Redhill Biopharma Ltd. has signed a manufacturing deal with two undisclosed companies in Europe and Canada to increase the production of its coronavirus treatment candidate, opaganib. The experimental cancer drug is currently being tested in two mid-stage trials for patients with severe Covid-19 pneumonia. The company is also in talks with U.S. government agencies for potential funding to support wider production of the drug.

PartnersExpand

Oct 14, 2020 ·

growth-positive

RedHill Biopharma Announces FDA Orphan Drug Designation for RHB-204 for the Treatment of NTM Infections

RedHill Biopharma Ltd. has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to RHB-204 for the treatment of nontuberculous mycobacteria (NTM) disease. The Orphan Drug Designation, along with RHB-204’s FDA QIDP priority designation, will extend U.S. potential market exclusivity to a total of 12 years. A Phase 3 study to evaluate the safety and efficacy of RHB-204 in patients with pulmonary NTM infections is planned to be initiated in the coming weeks in the U.S.

InvestmentExpand

Oct 8, 2020 ·

growth-positive

RedHill Biopharma Adds Israel Rights to Movantik® From AstraZeneca

RedHill Biopharma has acquired the rights to Movantik, a treatment for opioid-induced constipation, in Israel from AstraZeneca. This gives RedHill global rights to the drug, excluding Europe and Canada. The company is now considering partnering opportunities for the commercialization of Movantik in Israel. RedHill maintains sole and exclusive U.S. commercialization responsibility for Movantik, which generated approximately $20 million in net revenue in Q2/2020, the first quarter of sales as a RedHill product.

PartnersExpand

Oct 7, 2020 ·

growth-positive

RedHill Biopharma's Opaganib COVID-19 Study Passes Second Independent Committee Review

RedHill Biopharma Ltd. announced that the U.S. Phase 2 study with opaganib in patients hospitalized with severe COVID-19 pneumonia has passed its second pre-scheduled safety review by the independent Safety Monitoring Committee (SMC) with a unanimous recommendation to continue the study without change. The study is 75% enrolled. The company is in discussions with U.S. government agencies around potential funding to support the rapid advancement of opaganib toward potential emergency use approval and manufacturing scale-up.

Investment

Sep 22, 2020 ·

growth-positive

Brazil Approves RedHill Biopharma's Phase 2/3 COVID-19 Study with Opaganib

RedHill Biopharma Ltd. has received approval from the Brazilian Health Regulatory Agency for its ongoing global Phase 2/3 study evaluating opaganib in patients hospitalized with severe COVID-19 pneumonia. The study has been approved in Brazil, Israel, United Kingdom, Italy, Russia and Mexico, with further expansion ongoing and progressing rapidly. The U.S. Phase 2 study is approximately 75% enrolled, with enrollment set to be completed in the coming weeks. The company is in discussions with U.S. government agencies around potential funding to support the rapid advancement of opaganib toward potential emergency use approval.

InvestmentExpand

Sep 8, 2020 ·

growth-positive

RedHill Biopharma's Opaganib Demonstrates Complete Inhibition of SARS-CoV-2

RedHill Biopharma Ltd. has announced that its drug candidate, opaganib, demonstrated potent inhibition of SARS-CoV-2, the virus that causes COVID-19, in an in vitro model of human lung bronchial tissue. The drug is currently being evaluated in global Phase 2/3 and U.S. Phase 2 clinical studies for the treatment of severe COVID-19 pneumonia. The companys second COVID-19 drug candidate, RHB-107 (upamostat), also strongly inhibited SARS-CoV-2 viral replication in the same model. The company is in discussions with U.S. government agencies around potential funding to support the rapid advancement of opaganib toward potential emergency use approval.

InvestmentExpand

Sep 3, 2020 ·

growth-positive

RedHill Biopharma's Opaganib Awarded COVID-19 Grant by State of Pennsylvania

RedHill Biopharma Ltd. has been selected to receive a $300,000 grant from the State of Pennsylvania’s COVID-19 Vaccines, Treatments and Therapies (CV-VTT) Program. The grant will support the development of opaganib, a drug being evaluated for the treatment of severe COVID-19 pneumonia. The drug is currently undergoing a global Phase 2/3 study with up to 270 patients and a U.S. Phase 2 study with up to 40 patients. The grant was awarded to RedHill’s partner, Apogee Biotechnology Corporation, who will conduct the research supported by the grant.

InvestmentPartnersExpand

Aug 27, 2020 ·

growth-positive

RedHill Biopharma Announces Positive Recommendation from Independent Committee to Continue U.S. Phase 2 COVID-19 Study, and Approval of COVID-19 Phase 2/3 Study in Italy

RedHill Biopharma Ltd. has announced that its U.S. Phase 2 study with opaganib in patients with severe COVID-19 pneumonia has passed the first scheduled independent Safety Monitoring Committee (SMC) review. The SMC recommended that the study continue without change. The study is more than 50% enrolled and is expected to be completed in the coming weeks. The company also announced it has received approval from the Italian Medicines Agency for its Clinical Trial Authorization application for the global Phase 2/3 study evaluating opaganib in patients with severe COVID-19 pneumonia.

InvestmentExpand

Aug 13, 2020 ·

growth-positive

RedHill Biopharma and Cosmo Pharmaceuticals to Expand Strategic Partnership with Exclusive Licensing Agreement and Manufacturing Agreement for Multiple Products

RedHill Biopharma Ltd. has entered into a binding term sheet with Cosmo Pharmaceuticals N.V. for an exclusive licensing and manufacturing agreement for multiple products. The companies will co-develop a novel next-generation therapy for the eradication of H. pylori infection. Cosmo will receive the exclusive European rights to the new drug and will pay RedHill $7 million upon signing of the license agreement and an additional $2 million upon approval in Europe. Cosmo will also finance the planned pivotal Phase 3 clinical study with RHB-204, which recently received FDA clearance to proceed, with a payment of $5 million upon signing of the agreement and an additional $7 million in two milestone payments.

PartnersInvestment

Aug 11, 2020 ·

growth-positive

RedHill Biopharma's Phase 2/3 COVID-19 Study Approved in Mexico

RedHill Biopharma Ltd. has announced approval from the Mexican Federal Committee for the Protection against Sanitary Risks for the Phase 2/3 study evaluating opaganib in patients with severe COVID-19 and pneumonia. The study has also been approved in the UK and Russia and is under review in Italy, Brazil and other countries. The company plans to further expand the study to other countries. The study will enroll up to 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. If the studies are successful, the company plans to apply for emergency use authorizations as early as the fourth quarter of this year.

InvestmentExpand

Aug 3, 2020 ·

growth-positive

RedHill Biopharma Announces New Agreement with Daiichi Sankyo for Movantik®

RedHill Biopharma has replaced its existing co-commercialization agreement with Daiichi Sankyo for Movantik, a drug for opioid-induced constipation, with a new royalty-bearing agreement. RedHill acquired Movantik from AstraZeneca in April 2020. Under the new agreement, RedHill will bear all responsibilities and costs for commercializing Movantik in the U.S. and will pay Daiichi Sankyo a mid-teen royalty rate on net sales of Movantik in the U.S., in addition to three lump sum payments each year starting in 2021 and ending in 2023. Daiichi Sankyo also received 283,387 in American Depositary Shares of RedHill as a partial consideration in relation to Movantik.

AcquisitionPartners

Jul 31, 2020 ·

growth-positive

RedHill Biopharma Announces FDA Clearance for Pivotal Phase 3 Study with RHB-204 for NTM Infections

RedHill Biopharma Ltd. has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for a pivotal Phase 3 study to evaluate the efficacy and safety of RHB-204 in adults with pulmonary nontuberculous mycobacteria (NTM) disease. RHB-204 is a potential first-line oral treatment for pulmonary NTM infections, a rare disease with no FDA-approved first-line therapy. The study aims to enroll 125 patients at 50 clinical sites across the U.S. RHB-204 was granted QIDP designation and is eligible for Fast-Track development, NDA priority review and a total of eight years of U.S. market exclusivity, if approved.

Investment

Jul 30, 2020 ·

growth-positive

RedHill Biopharma Initiates Global Phase 2/3 Study for COVID-19

RedHill Biopharma Ltd. has initiated a global Phase 2/3 clinical study to evaluate opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia requiring treatment with supplemental oxygen. The study will enroll up to 270 patients across 40 clinical sites and has been approved in the UK and Russia, with reviews underway in Italy, Brazil, and Mexico. A parallel U.S. Phase 2 study is expected to be completed in August 2020. If successful, the program is intended to support emergency use applications globally.

InvestmentExpand

Jul 28, 2020 ·

growth-positive

RedHill Biopharma Publishes Positive IBS-D Phase 2 Study Data in The American Journal of Gastroenterology

RedHill Biopharma Ltd. has announced the publication of data from its Phase 2 study of RHB-102 (Bekinda®), a novel, proprietary, once-daily, 12mg bimodal-release ondansetron, in diarrhea-predominant irritable bowel syndrome (IBS-D). The study showed that RHB-102 delivers a clinically meaningful improvement in overall stool consistency response versus placebo in patients with IBS-D. The publication also highlights that elevated baseline C-reactive protein (CRP) may be used to identify treatment responders in this complex disease. The company is currently finalizing the design of two pivotal Phase 3 studies for IBS-D.

InvestmentExpand

Jul 22, 2020 ·

growth-positive

RedHill Biopharma Accelerates Phase 2/3 COVID-19 Program with Addition of Brazil and Mexico

RedHill Biopharma Ltd. has announced the submission of a Clinical Trial Application (CTA) with the Mexican Federal Committee for the Protection against Sanitary Risks (COFEPRIS) and initiated CTA submission with the Brazilian Health Regulatory Agency (ANVISA) for the Phase 2/3 clinical study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia. The companys CTA applications for this study have already been approved in the UK and Russia and a similar application is under review in Italy. The company plans to expand the study to additional countries.

CustomersExpand

Jul 16, 2020 ·

growth-positive

RedHill Biopharma Receives Approval for Phase 2/3 COVID-19 Study in Russia

RedHill Biopharma Ltd. has received approval from the Ministry of Health of the Russian Federation for its Clinical Trial Authorization (CTA) application for a Phase 2/3 study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia. The study was also recently approved in the UK and a similar application is under review in Italy with plans to further expand the study to additional countries. The company plans to submit an application for Emergency Use Authorization in the fourth quarter this year.

InvestmentExpand

Jun 29, 2020 ·

growth-positive

RedHill Biopharma Receives Approval for COVID-19 Phase 2/3 Study with Opaganib in the UK

RedHill Biopharma Ltd. has received approval from the UK Medicines & Healthcare products Regulatory Agency to commence a Phase 2/3 study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia. The study aims to enroll 270 severe COVID-19 patients in up to 40 clinical sites across the UK, Italy, Russia and additional countries. In parallel, a U.S. study with opaganib in up to 40 severe COVID-19 patients has been initiated at leading medical centers.

CustomersExpand

Jun 24, 2020 ·

growth-positive

Publication of Data from Severe COVID-19 Patients Shows Substantial Benefit to Patients Treated with RedHill's Opaganib Compared to Matched Case-Control Group

RedHill Biopharma Ltd. has announced positive results from the treatment of severe COVID-19 patients with its investigational drug, opaganib. The results showed substantial benefits to patients in both clinical outcomes and inflammatory markers compared to a matched case-control group. The company has submitted applications for a Phase 2/3 Clinical Trial for a study with opaganib in 270 patients with severe COVID-19 to be conducted in up to 40 clinical sites across Russia, Italy, the UK and additional countries. A study with opaganib in up to 40 patients with severe COVID-19 has also been initiated at leading medical centers across the U.S.

InvestmentExpand

Jun 18, 2020 ·

growth-positive

RedHill Biopharma Expands Opaganib COVID-19 Phase 2/3 Study with Clinical Trial Applications in Italy and UK

RedHill Biopharma Ltd. has announced that it has submitted Clinical Trial Applications with the UK Medicines & Healthcare Products Regulatory Agency and the Italian Medicines Agency for a Phase 2/3 clinical study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia. The study is planned to be conducted in up to 40 clinical sites across Russia, Italy, the UK and additional countries. In parallel, a clinical study of opaganib in up to 40 severe COVID-19 patients has been approved by the FDA and is open for recruitment in the U.S.

InvestmentCustomers

Jun 10, 2020 ·

growth-positive

RedHill Biopharma Submits COVID-19 Clinical Trial Application for Phase 2/3 Study with Opaganib

RedHill Biopharma Ltd. has submitted a Clinical Trial Application (CTA) with the Ministry of Health of the Russian Federation for a Phase 2/3 clinical study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia. The study is planned to enroll 270 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygenation. In parallel, RedHill is initiating enrollment for a randomized, double-blind, placebo-controlled Phase 2a clinical study with opaganib in the U.S.

InvestmentExpand

Jun 8, 2020 ·

growth-positive

RedHill Biopharma to Provide Update on its COVID-19 and other Development Programs at MedInvest Virtual Infectious Diseases and Immunology Conference

RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced that its Chief Operating Officer, Mr. Gilead Raday, will present the companys development program with opaganib for COVID-19 and the Phase 3 development program with RHB-204 for pulmonary nontuberculous mycobacteria (NTM) infections at the MedInvest Virtual Infectious Diseases and Immunology Conference on June 15, 2020. The presentation will be broadcast live and available via replay for 30 days on the companys website.

Management Changes

May 8, 2020 ·

growth-positive

RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study with Opaganib in the U.S.

RedHill Biopharma Ltd. has received approval from the U.S. Food and Drug Administration (FDA) for a Phase 2a clinical study evaluating its investigational drug, opaganib, in patients with confirmed moderate-to-severe SARS-CoV-2 infection. The study aims to enroll up to 40 patients with moderate-to-severe COVID-19 pneumonia in the U.S. Preliminary findings from six moderate-to-severe COVID-19 patients treated with opaganib in Israel under compassionate use have shown that all the patients demonstrated both subjective and objective significant measurable clinical improvement within days following treatment initiation with opaganib.

InvestmentExpand

May 5, 2020 ·

growth-positive

RedHill Biopharma Announces Publication of Talicia® Pivotal Phase 3 Study Results in Annals of Internal Medicine

RedHill Biopharma Ltd. has announced the publication of its pivotal Phase 3 study results with Talicia for Helicobacter pylori (H. pylori) infection. The drug was approved by the FDA in November 2019 and is the only rifabutin-containing therapy approved for the treatment of H. pylori infection. The drug is designed to address the high and growing resistance of H. pylori to the currently widely used clarithromycin-containing regimens. The double-blind, randomized, controlled trial demonstrated the added rifabutin benefit with 83.8% eradication of H. pylori infection with Talicia.

CustomersExpand

Apr 20, 2020 ·

growth-positive

RedHill Biopharma Announces Agreement with NIAID to Evaluate RHB-107 Against COVID-19

RedHill Biopharma Ltd. has announced a partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to provide its investigational drug, RHB-107, for testing in non-clinical studies for activity against SARS-CoV-2, the virus that causes COVID-19. The drug has been studied in more than 300 people across 10 clinical studies, including two completed Phase 2 studies in oncology patients and several Phase 1 studies in healthy volunteers and oncology patients. The studies helped establish the safety and tolerability of RHB-107 in humans.

Partners

Apr 13, 2020 ·

growth-positive

RedHill Biopharma Provides Initial Update from its Opaganib COVID-19 Compassionate Use Program in Israel

RedHill Biopharma Ltd. has reported initial positive results from the compassionate use of its investigational drug, opaganib, in treating COVID-19 patients in Israel. The first two patients treated showed clinical improvement within days, including decreased oxygen requirements and decreased C-reactive protein levels. The drug was well tolerated and no adverse events have been reported. The company is planning to treat approximately 160 patients in Italy under an expanded access program and is in discussions to increase the accessibility of opaganib in the U.S. and other countries.

CustomersPartnersExpand

Apr 7, 2020 ·

www.timesofisrael.com

Israel's Redhill Biopharma gets green light for experimental COVID-19 treatment

Mar 15, 2020 ·

www.israel21c.org

growth-positive

Israeli pharma company launches drug for H. pylori in US market

RedHill Biopharma has announced the US commercial launch of Talicia, a delayed-release capsule for treating Helicobacter pylori (H. pylori) infection in adults. H. pylori bacterial infection affects approximately 35 percent of the US population and more than 50% of the worldwide population. The companys expanded US sales force will promote Talicia nationwide to approximately 25,000 gastroenterologists, primary care physicians and other healthcare providers.

CustomersExpand

Mar 11, 2020 ·

growth-positive

RedHill Biopharma Provides Update on Opaganib (Yeliva®)

RedHill Biopharma has initiated a Phase 2 study evaluating its proprietary opaganib in prostate cancer at the Medical University of South Carolina, supported by a National Cancer Institute grant. The company has also started recruitment for a second arm of a Phase 1/2a study evaluating opaganib in combination with hydroxychloroquine in advanced cholangiocarcinoma. RedHill is also planning to evaluate a combination of opaganib with RHB-107 (upamostat), a second proprietary new chemical entity, for the treatment of COVID-19.

InvestmentExpand

Feb 25, 2020 ·

growth-positive

RedHill Biopharma Enters $115 Million Non-Dilutive Financing Agreement with HealthCare Royalty Partners

RedHill Biopharma Ltd. has entered into a non-dilutive, royalty-backed term loan agreement with HealthCare Royalty Partners (HCR), which has committed up to $115 million to support RedHill’s U.S. commercial operations. The financing will support the acquisition of rights to Movantik from AstraZeneca, the planned U.S. launch of Talicia this quarter and the ongoing promotion of Aemcolo. RedHill will receive $30 million following the closing to support its commercial operations, and an additional $50 million to fund the acquisition of rights to Movantik. Two additional tranches totaling $35 million will be available to further support RedHill’s commercial operations.

InvestmentAcquisitionPartners

Feb 25, 2020 ·

en.globes.co.il

growth-positive

RedHill buys AstraZeneca constipation drug rights

RedHill Biopharma Ltd. has acquired the global rights (excluding Europe) for the Movantik treatment of gastrointestinal diseases from AstraZeneca for $67.5 million. The acquisition will be financed by a non-dilutive, royalty-backed term loan from HealthCare Royalty Partners (HCR), as part of the previously announced $115 million non-dilutive financing by HCR to support RedHill’s US commercial operations. RedHill will make an upfront payment of $52.5 million to AstraZeneca upon closing and a further non-contingent payment of $15 million 18 months post-closing.

AcquisitionInvestment

Jan 27, 2020 ·

growth-positive

RedHill Biopharma Launches H. pylori Disease State Awareness Field Campaign Ahead of Talicia® Launch

RedHill Biopharma Ltd. is set to launch Talicia in the U.S. in Q1 2020 for the treatment of H. pylori infection in adults. The company has initiated a nationwide H. pylori disease state educational field campaign led by its sales force, ahead of the planned U.S. launch of Talicia. The campaign aims to raise awareness among healthcare professionals about the risks related to H. pylori infection and the high and growing resistance of the H. pylori bacterium to standard-of-care antibiotics.

CustomersExpand

Jan 21, 2020 ·

growth-negative

RedHill Biopharma to Focus Commercial Efforts on Talicia® and Aemcolo®;Discontinuing Promotion of Legacy Products

RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced its decision to discontinue its co-promotion and commercialization agreements for Donnatal® and EnteraGam® to focus on its lead commercial products, Talicia® and Aemcolo®. The company provided a notice of termination to Entera Health regarding the license agreement for EnteraGam® and the co-promotion agreement with Advanz Pharma Corp. for Donnatal® will not be renewed. The company has been promoting Donnatal® and EnteraGam® since mid-2017. The company initiated promotion of Aemcolo® in the U.S. in December 2019 and Talicia® was approved by the U.S. FDA in November 2019 and is planned to be launched in the first quarter of 2020.

Partners

Jan 2, 2020 ·

growth-positive

RedHill Biopharma Regains Rights to its Proprietary Bowel Preparation RHB-106

RedHill Biopharma Ltd. has announced the termination of its 2014 license agreement with Salix Pharmaceuticals Ltd. and has regained the worldwide exclusive rights to RHB-106, a proprietary encapsulated formulation for bowel preparation. RedHills CEO, Dror Ben-Asher, stated that the company is pleased to regain the rights to RHB-106 as it aligns well with their expanded gastrointestinal-focused commercial activities in the U.S. The company plans to pursue its development toward potential U.S. FDA approval.

Partners

Dec 17, 2019 ·

growth-positive

RedHill Biopharma Initiates U.S. Promotion of Aemcolo® for Travelers' Diarrhea

RedHill Biopharma Ltd. has announced the promotion of its FDA-approved antibiotic, Aemcolo, for the treatment of travelers diarrhea in the US. Aemcolo uses MMX technology to deliver the antibiotic directly to the lower intestine. The company is expanding its sales force to approximately 140 representatives to ensure an optimal launch for Aemcolo and Talicia, another drug for the treatment of H. pylori infection in adults. RedHill entered into a strategic collaboration with Cosmo Pharmaceuticals, including an exclusive license agreement for the US rights to Aemcolo and a simultaneous private investment by Cosmo Pharmaceuticals of $36.3 million.

CustomersPartnersInvestmentExpand

Nov 15, 2019 ·

growth-positive

Dual-Listed RedHill Biopharma to Voluntarily Delist from Tel-Aviv Stock Exchange

RedHill Biopharma Ltd., a specialty biopharmaceutical company, has announced that it will voluntarily delist its ordinary shares from trading on the Tel Aviv Stock Exchange (TASE). This will take place at least 90 days after the announcement, which is expected to be on or about February 13, 2020. RedHills American Depositary Shares (ADSs) will continue to trade on the Nasdaq Global Market under the symbol “RDHL”. The company has confirmed that there is nothing to prevent the company’s ordinary shares that are traded on the TASE from trading on the Nasdaq Global Market as ADSs representing ordinary shares shortly after the delisting from the TASE.

Public Trading

Nov 12, 2019 ·

growth-positive

RedHill Biopharma Announces Publication of RHB-102 Gastroenteritis Phase 3 Study Results in JAMA

RedHill Biopharma Ltd. has announced the publication of positive results from its Phase 3 study of RHB-102 (Bekinda) in the treatment of acute gastroenteritis. The study, published in the Journal of the American Medical Association Network Open, found that the drug was well tolerated and could be safely administered to patients with acute gastroenteritis. The company is now working towards a confirmatory Phase 3 study to support a potential New Drug Application for the treatment of acute gastroenteritis and gastritis. RedHill is also developing RHB-102 in a different dosage for the treatment of diarrhea-predominant irritable bowel syndrome.

InvestmentExpand

Nov 5, 2019 ·

RedHill Receives FDA Approval for H. Pylori Gastric Drug

Oct 18, 2019 ·

growth-positive

RedHill Biopharma Announces $36 Million Strategic Investment by Cosmo Pharmaceuticals and U.S. Rights to Approved Travelers' Diarrhea Drug AEMCOLO

RedHill Biopharma Ltd. has announced a strategic collaboration with Cosmo Pharmaceuticals N.V., which includes an exclusive license agreement for the U.S. rights to Aemcolo® (rifamycin) and a simultaneous private investment by Cosmo of $36.3 million in RedHill. The collaboration will allow RedHill to commercialize Aemcolo® in the U.S. for Traveler’s Diarrhea and agreed to act as the exclusive supplier of Aemcolo®. The license agreement also provides for the grant to RedHill of certain rights related to the potential development of additional indications for Aemcolo®, as well arrangements related to other pipeline product candidates of Cosmo.

InvestmentPartners

Oct 11, 2019 ·

growth-positive

RedHill Biopharma Announces Full Results from Positive MAP US Phase 3 Study and Supportive Top-Line Results from MAP US2 Open-Label Extension Study with RHB-104 in Crohn's Disease

RedHill Biopharma Ltd. has announced positive results from its Phase 3 study of RHB-104 in Crohn’s disease. The study met its primary endpoint of clinical remission at week 26 and key secondary endpoints of maintenance of remission at weeks 16 and 52. The company also reported supportive top-line results from an open-label extension Phase 3 study evaluating the safety and efficacy of RHB-104 in subjects with persistent active Crohn’s disease. The results further support the potential clinical benefit of treatment with RHB-104 in Crohn’s disease patients. RedHill plans to meet with the FDA again in the coming months to discuss the RHB-104 program.

Investment

Aug 21, 2019 ·

growth-positive

RedHill Biopharma Announces Acceptance of Oral Presentations on RHB-105 (H. pylori) and RHB-104 (Crohn's Disease) Phase 3 Data at ACG 2019 Annual Scientific Meeting

RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced that it will present data from the positive Phase 3 clinical studies of RHB-105 (Talicia®) for H. pylori infection and RHB-104 for Crohn’s disease at the upcoming American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting. An oral presentation on RHB-105 (Talicia) was also accepted for presentation at the XXXIInd International Workshop on Helicobacter & Microbiota in Inflammation and Cancer of the European Helicobacter and Microbiota Study Group (EHMSG 2019).

InvestmentExpand

Jul 3, 2019 ·

growth-positive

RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia®

RedHill Biopharma Ltd. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Talicia (RHB-105) for H. pylori infection. The NDA for Talicia has also been granted Priority Review designation and was assigned a target Prescription Drug User Act (PDUFA) action date by the FDA of November 2, 2019. If approved, Talicia would be eligible for a total of eight years of U.S. market exclusivity. The commercial launch of Talicia with RedHill’s existing U.S. sales force is planned shortly following potential FDA approval.

InvestmentCustomers

Jun 10, 2019 ·

growth-positive

RedHill Biopharma Receives Allowance for New U.S. Patent Covering RHB-104 for Crohn's Disease and RHB-204 for NTM Infections

RedHill Biopharma Ltd. has announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering RHB-104 for Crohn’s disease and RHB-204 for Mycobacterium avium complex (MAC) disease. The patent is expected to be valid until at least 2029. The company plans to initiate a pivotal Phase 3 study with RHB-204 for the treatment of pulmonary NTM infections in the second half of 2019. RedHill also plans to meet with the FDA in the second half of 2019 to discuss the development path toward potential approval of RHB-104.

InvestmentExpand

May 28, 2019 ·

growth-positive

RedHill Biopharma Appoints Dr. June Almenoff as Chief Scientific Officer

RedHill Biopharma Ltd., a specialty biopharmaceutical company primarily focused on gastrointestinal diseases, has announced the appointment of Dr. June S. Almenoff as Chief Scientific Officer. Dr. Almenoff, who has over 20 years of experience in the pharmaceutical industry, will lead the companys commercial strategy relating to medical and scientific matters. This includes the medical affairs activities for Talicia (RHB-105) in preparation for a potential U.S. commercial launch in the fourth quarter of 2019. Dr. Almenoff will also oversee the clinical development of RHB-204 for pulmonary nontuberculous mycobacteria (NTM) infections and the pivotal Phase 3 study planned to be initiated in the second half of 2019.

Management ChangesExpand

May 21, 2019 ·

growth-positive

RedHill Biopharma Expands Commercial Management Team Ahead of Planned Talicia® Launch

RedHill Biopharma Ltd., a specialty biopharmaceutical company focused on gastrointestinal diseases, has announced the expansion of its commercial management team with several key executive hires. This comes ahead of the potential U.S. launch of Talicia. The company has appointed Rob Jackson as Vice President of Marketing, Robert J. Gilkin, Jr. as Vice President of Market Access and Steven Thomasian as Vice President of Supply Chain. These new members will play a significant role in the potential FDA approval and commercial launch of Talicia in the fourth quarter of 2019.

Management ChangesExpand

May 7, 2019 ·

growth-positive

RedHill Biopharma Submits New Drug Application for Talicia® for H. pylori Infection

RedHill Biopharma Ltd. has submitted a New Drug Application (NDA) to the FDA for Talicia (RHB-105) for the treatment of H. pylori infection. The NDA follows a recent positive pre-NDA meeting with the FDA. If approved, Talicia will receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period, for a total of eight years of market exclusivity. Talicia is also covered by U.S. patents which extend patent protection until at least 2034. RedHill continues to strengthen its U.S. commercial operations with senior industry executives ahead of the planned commercial launch of Talicia, as early as Q4/2019.

InvestmentExpand

Mar 4, 2019 ·

growth-positive

RedHill Biopharma Announces New European and Japanese Patents for Talicia®

RedHill Biopharma Ltd., a specialty biopharmaceutical company, has announced that the European Patent Office (EPO) and the Japan Patent Office (JPO) have accepted pending patent applications for Talicia (RHB-105) for H. pylori infection. The patents, once granted, are expected to be valid until 2034. Talicia is a novel and proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI), omeprazole, that is being developed for the eradication of H. pylori infection.

Investment

Jan 17, 2019 ·

globenewswire.com

growth-positive

RedHill Biopharma Announces Fifth U.S. Patent Covering TALICIA® for H. pylori Infection

RedHill Biopharma Ltd. has received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering TALICIA (RHB-105), a drug being developed for the eradication of H. pylori infection. The patent is expected to be valid until at least 2034. TALICIA is also eligible for a total of eight years of U.S. market exclusivity under its FDA Qualified Infectious Disease Product (QIDP) status. RedHill plans to submit a New Drug Application to the FDA in H1/2019 and plans the U.S. commercial launch of TALICIA for H2/2019, subject to FDA approval.

Investment

Dec 9, 2018 ·

en.globes.co.il

growth-positive

RedHill Biopharma raises $20m on Nasdaq

Israeli drug developer RedHill Biopharma Ltd. has raised $20 million on Nasdaq. The company issued 2,857,143 American Depositary Shares (ADS), each representing ten of its ordinary shares, at a public offering price of $7.00 per ADS. The funds will be used for the commercial launch of H.pylori drug TALICIA and two phase III clinical trials. The companys existing cash and cash equivalents totaled $43 million at the end of the third quarter.

Investment

Dec 3, 2018 ·

www.timesofisrael.com

Israel's RedHill says drug shown effective in eradicating gut infection

Jul 30, 2018 ·

www.timesofisrael.com

RedHill's drug for Crohn's disease shows positive results - study

Jul 24, 2018 ·