Gamida Cell News
99 articlesBioLineRx and Ayrmid Ltd. Enter into Exclusive License Agreement to Commercialize APHEXDA® (motixafortide) through Gamida Cell Ltd.
Growth-Positive
Gamida Cell has a second chance to be an Israeli success story
Gamida Cell, an Israel-based biopharmaceutical company specializing in cancer treatment, has been struggling financially. The companys proprietary NAM stem-cell technology, available under the Omisirge product, has the potential to extend the lives of cancer patients. However, due to financial difficulties, Gamida Cell was at risk of insolvency. In a bid to save the company, a court-approved creditor arrangement was commenced, supported by Highbridge Capital Management, LLC. This plan aims to address the companys capital needs and keep Omisirge available for patients. The restructuring plan gives Gamida Cell a new lease on life and opens up its prospects, including expanding Omisirge’s footprint to onboard more patients.
InvestmentManagement Changes
growth-positive
XORTX Welcomes New Member to the Board of Directors
XORTX Therapeutics Inc., a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, has appointed Abigail Jenkins to its Board of Directors. Jenkins, who is currently the President and CEO of Gamida Cell, brings over 20 years of leadership experience in the biopharmaceutical industry. Her experience with innovative drug delivery systems and the launches of novel therapeutics will be valuable to the company as it prepares for commercialization of its drug candidates. In connection with her appointment, XORTX has granted Jenkins 8,000 options to purchase common shares of the company.
Management Changes
growth-positive
Aquestive Therapeutics Strengthens Board of Directors with Experienced Biotech Executive
Aquestive Therapeutics, Inc., a pharmaceutical company, has announced the appointment of Abigail Jenkins to the Company’s Board of Directors, effective April 1, 2024. Jenkins, a veteran biotech executive with over 20 years of experience in commercial leadership, is expected to be a vital asset to the company. The appointment is part of Aquestives steps in re-establishing its commercial capabilities. The company is currently developing its first and only orally administered epinephrine product candidate, Anaphylm.
Management Changes
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Q4 2023 Gamida Cell Ltd Earnings Call
Gamida Cell Ltd announced a restructuring process supported by Highbridge Capital Management, which will convert $75 million of its existing unsecured convertible senior note into all of the equity in the company. The company will receive $30 million of new capital from Highbridge on the effective date of the restructuring. Gamida Cell will become a private company, wholly owned by Highbridge and the companys outstanding ordinary shares will be canceled. The company also announced a headcount reduction of approximately 25% of its team, to align with the current business conditions and its focus on Omisirge commercialization. The restructuring transaction is expected to close in the second quarter of 2024.
Management ChangesLayoffs
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Gamida Cell Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Company Update
Gamida Cell Ltd. has announced a restructuring process supported by Highbridge Capital Management. Highbridge will convert $75 million of its existing unsecured convertible senior note into equity in the company and provide $30 million of new capital. The restructuring will result in Gamida Cell becoming a private company, wholly owned by Highbridge. The company also plans to lay off 25% of its workforce. Despite these changes, Gamida Cell continues to make progress with the launch of its product, Omisirge, with six units delivered in 2023.
InvestmentLayoffs
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Gamida Cell Announces Commencement of Restructuring Process Supported by Highbridge Capital Management
Gamida Cell Ltd. has entered into a Restructuring Support Agreement with Highbridge Capital Management, its principal lender. Highbridge will convert $75 million of its existing unsecured convertible senior note into equity in Gamida Cell and provide $30 million of new capital on the effective date of the restructuring. Additional capital is expected to be invested by Highbridge following the company’s emergence. Gamida Cell will become a private company, wholly owned by Highbridge. The restructuring will support the ongoing commercialization of Omisirge® (omidubicel-onlv), a potentially lifesaving donor source option.
InvestmentAcquired-by
Growth-Positive
Gamida Cell Announces Commencement of Restructuring Process Supported by Highbridge Capital Management
Gamida Cell Ltd., a cell therapy pioneer, has announced a Restructuring Support Agreement with Highbridge Capital Management, its principal lender. The agreement will provide Gamida Cell with a long-term financial runway and support the ongoing commercialization of its stem cell transplant Omisirge. Highbridge will convert $75 million of its existing unsecured convertible senior note into equity in the company and will provide $30 million of new capital on the effective date of the restructuring. Gamida Cell will become a private company, wholly owned by Highbridge, upon the completion of the restructuring.
InvestmentAcquired-by
growth-negative
Gamida Cell to delist as Highbridge takes full ownership
Israeli stem cell treatment company Gamida Cell is set to go private as Highbridge Capital Management, the companys principal lender, converts its $75 million bond into shares. The company, which has a market cap of $45 million, will also lay off 25% of its workforce and close its Jerusalem development center. This comes after a challenging period for Gamida Cell, with its share price having lost 95% since its IPO. Highbridge will inject an additional $30 million into the company, and more if the product achieves certain milestones.
LayoffsAcquisitionInvestment
growth-negative
Unable to find a partner for stem cell therapy, Gamida accepts sale to investment firm to survive
Gamida Cell, a biotech company, is set to be acquired by its principal lender, Highbridge Capital Management, after failing to find a partner for its approved stem cell therapy, Omisirge. Highbridge will convert $75 million of existing unsecured convertible senior notes into equity and provide $30 million of new capital. This comes after Gamida struggled with limited resources, leading to layoffs in 2022 and 2023, and the deprioritization of preclinical work on natural killer (NK) cell therapies. The acquisition will allow Gamida to continue commercializing Omisirge and remain a going concern.
Acquired-byLayoffs
Neutral
Gamida Cell to Report Fourth Quarter and Full-Year 2023 Financial Results
Gamida Cell Ltd., a pioneer in cell therapy, announced that it will release its financial results for the fourth quarter and full year ended December 31, 2023, and provide a company update on Wednesday, March 27, 2024. Following the release, the management will host a conference call and live webcast to discuss the financial results and provide a business update. The companys proprietary nicotinamide (NAM) technology is used to create allogeneic cell therapy products and candidates for patients with hematologic malignancies.
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Gamida Cell Data Presented at the 2024 Tandem Meetings of ASTCT® and CIBMTR®
Gamida Cell Ltd. has presented data from its expanded access program (EAP) for FDA-approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and Phase 1 data for its allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings. The data showed promising results in terms of hematopoietic recovery and anti-tumor activity. The EAP study provided the opportunity to treat patients after completion of enrollment of the Phase 3 trial and prior to the approval of Omisirge. The Phase 1 data on GDA-201 further support the anti-tumor activity of Gamida Cells NAM-enhanced cellular therapy.
Customers
Growth-Negative
Gamida Cell Actively Pursuing Strategic Alternatives
On January 29, 2024, Gamida Cell Ltd. announced that it is actively pursuing strategic alternatives to maximize value for all stakeholders. These alternatives may include an asset sale, merger, or other strategic transaction. However, the company has not guaranteed that this process will result in any such transaction. In the meantime, Gamida Cell continues to focus on the commercialization of Omisirge, its FDA-approved cell therapy product. Moelis & Company LLC is acting as the financial advisor for this process.
Management Changes
growth-positive
Gamida Cell to Present at the 2024 Tandem Meetings of ASTCT® and CIBMTR®
Gamida Cell Ltd. announced it will present new data on its FDA approved allogeneic stem cell therapy Omisirge and allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy Meetings. The meetings will take place virtually and in person at the Henry B. González Convention Center in San Antonio, Texas, February 21-24. The companys proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies.
InvestmentExpand
Growth-Positive
Gamida Cell to Host Virtual Thought Leader Fireside Chat on December 4, 2023
Gamida Cell Ltd., a pioneer in cell therapy, is hosting a virtual fireside chat with thought leader Gary Schiller, MD, FACP, Professor of Medicine and Director of the Hematological Malignancy & Stem Cell Transplant Program at the University of California – Los Angeles. Dr. Schiller will discuss his experience with patients in need of allogeneic stem cell transplant, the patient journey from diagnosis to transplant, the decision-making process for donor source selection, and his experience with Omisirge® (omidubicel-onlv) since its FDA approval. The event is intended for institutional investors, sell-side research analysts and business development professionals.
Management Changes
Growth-Positive
Gamida Cell to Present Corporate Highlights at the Piper Sandler 35th Annual Healthcare Conference
Gamida Cell Ltd., a pioneer in cell therapy, announced that its management team will present corporate highlights at the upcoming Piper Sandler 35th Annual Healthcare Conference in New York. The presentation will be in the form of a fireside chat and the management team will also be available for one-on-one meetings during the conference. Gamida Cell is known for its proprietary nicotinamide (NAM) technology that enhances and expands cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies.
Management Changes
growth-positive
Gamida Cell Ltd. (NASDAQ:GMDA) Q3 2023 Earnings Call Transcript
Gamida Cell Ltd. reported its Q3 2023 financial results, beating earnings expectations. The company also provided an update on its operations, including the launch of its cell therapy candidate, Omisirge, and its plans for commercial or strategic partnerships. The company reported revenue for the first time in its history, resulting from the delivery of two units of Omisirge. Gamida Cell is also seeking necessary funding to support expanded patient access to Omisirge and enable a strategic partnership for its full commercialization. The company also shared preliminary data from the Phase 1 clinical trial for GDA-201 and plans to share the full data readout in early 2024.
CustomersManagement ChangesInvestment
growth-positive
Q3 2023 Gamida Cell Ltd Earnings Call
Gamida Cell Ltd. reported its third-quarter 2023 financial results, announcing the successful launch of its cell therapy product, Omisirge. The company exceeded its goals for transplant center onboarding and market access, reporting revenue from two deliveries of Omisirge in the third quarter. Gamida Cell projects four to six deliveries of Omisirge units for the full-year 2023. The company is also seeking a strategic partnership to fully resource the commercialization of Omisirge. Despite the ongoing Israel-Hamas war, operations in Israel continue, with the team adapting processes to ensure patient access to Omisirge.
CustomersInvestmentExpand
growth-positive
Gamida Cell Reports Third Quarter 2023 Financial Results and Provides Company Update
Gamida Cell Ltd., a cell therapy pioneer, reported its financial results for Q3 2023, marking the first revenue from its product Omisirge following FDA approval. The company has onboarded 17 transplant centers, surpassing its target range of 10 to 15 for 2023. It also reported confirmed coverage with U.S. payers covering more than 90% of commercial lives, exceeding its full-year goal of 70%. Looking to 2024, the company plans to onboard more than 40 transplant centers, contingent on additional funding. The companys manufacturing facility in Israel has remained operational amid the ongoing Israel-Hamas war.
CustomersInvestmentExpand
growth-positive
Gamida Cell Presents New Data on Allogeneic Stem Cell Therapy Omidubicel and Natural Killer (NK) Cell Therapy Candidate GDA-201 at Society for Immunotherapy of Cancer (SITC) Annual Meeting
Gamida Cell Ltd., a cell therapy pioneer, has shared new data on the impact of its proprietary nicotinamide (NAM) technology on its allogeneic stem cell therapy omidubicel and investigational natural killer (NK) cell therapy candidate GDA-201. Both therapies are powered by Gamida Cell’s proprietary NAM technology, which enhances and expands cells to create potentially curative cell therapies for patients with cancer. Omidubicel was approved by the U.S. FDA in April 2023 for allogeneic stem cell transplant; GDA-201 is in Phase 1 study for the treatment of non-Hodgkin lymphoma.
InvestmentExpand
Neutral
Gamida Cell to Report Third Quarter 2023 Financial Results
Gamida Cell Ltd., a pioneer in cell therapy, announced that it will release its financial results for the third quarter ended September 30, 2023, and provide a company update on Tuesday, November 14, 2023. Following the release, the management will host a conference call and live webcast to discuss the financial results and provide business updates. The companys proprietary nicotinamide (NAM) technology is used to create allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies.
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Gamida Cell Reports Preliminary Data from Phase 1 Study of Natural Killer (NK) Cell Therapy Candidate GDA-201
Gamida Cell Issues Update on Israel Operations
Growth-Positive
Gamida Cell to Present Corporate Highlights at 2023 Cell & Gene Meeting on the Mesa
Gamida Cell Ltd, a cell therapy pioneer, announced that its President and CEO, Abbey Jenkins, will present the companys highlights at the annual Cell & Gene Meeting on the Mesa. The event will take place from October 10-12 in Carlsbad, California, and will be livestreamed globally. Jenkins will share updates on the commercial launch of Omisirge, the companys allogeneic stem cell therapy, and provide an overview of the market opportunity. The meeting is organized by the Alliance for Regenerative Medicine and features presentations by companies highlighting technical and clinical achievements in cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies.
Management ChangesExpand
Pleasing Signs As A Number Of Insiders Buy Gamida Cell Stock
Gamida Cell to Present at Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting
First Patient Receives Gamida Cell's Omisirge™ (omidubicel-onlv)
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Gamida Cell to Present Corporate Highlights at the H.C. Wainwright 25th Annual Global Investment Conference
Gamida Cell will present corporate highlights at the H.C. Wainwright 25th Annual Global Investment Conference. The company is a cell therapy pioneer working on turning cells into powerful therapeutics. They have proprietary technology leveraging nicotinamide (NAM) to enhance and expand cells for potential curative treatments. Gamida Cells products include Omisirge, an FDA-approved allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate. The companys management team will be available for one-on-one meetings during the conference.
InvestmentManagement Changes
growth-positive
Retail investors account for 54% of Gamida Cell Ltd.'s (NASDAQ:GMDA) ownership, while institutions account for 29%
The article discusses the ownership structure of Gamida Cell Ltd. and the impact it has on the company. Retail investors hold a majority stake of 54% in the company, while institutions own 29% of the stock. The article highlights that institutional ownership can indicate credibility in the investment community, but also warns of the risks associated with a crowded trade. Hedge funds do not own shares in Gamida Cell. The largest shareholders are FMR LLC, Heights Capital Management, Inc., and Community US Fund Management, Inc. Insiders also hold shares in the company, but their ownership is relatively low. The general public collectively holds 54% of the shares, giving them some influence over company decisions. Private equity firms own 5.8% of the stock, potentially shaping corporate strategy. Private companies and public companies also have ownership stakes in Gamida Cell.
Investment
growth-positive
Q2 2023 Gamida Cell Ltd Earnings Call
Gamida Cell Ltd. has reported significant progress in the commercial launch of its product Omisirge, a stem cell donor source. The company has onboarded 12 transplant centers and is in the process of onboarding eight more, exceeding its goal for the year. Coverage has been confirmed with US payers that cover more than 85% of commercial lives, including nine out of the top 10 payers. Gamida Cell also plans to hire additional account managers and medical science liaisons to support the demand for Omisirge. The company is also pursuing strategic partnerships to expand transplant center onboarding and accelerate patient access to Omisirge.
InvestmentManagement ChangesExpand
growth-positive
Gamida Cell Reports Second Quarter and First Half 2023 Financial Results and Provides Company Update
Gamida Cell Ltd., a cell therapy pioneer, has reported a strong start for the launch of its product, Omisirge® (omidubicel-onlv), with significant payer coverage and a number of transplant centers onboarded exceeding expectations. The company is also pursuing a strategic partnership to further support the Omisirge launch. Gamida Cell has extended its cash runway into Q2 2024 and reduced its debt by $9 million. The company also announced management changes, including the appointment of Terry Coelho as Chief Financial Officer and Jeremy Blank to the Board of Directors.
CustomersPartnersManagement ChangesInvestment
Neutral
Gamida Cell to Report Second Quarter 2023 Financial Results
Gamida Cell Ltd., a pioneer in cell therapy, has announced that it will release its financial results for the second quarter ended June 30, 2023, on Monday, August 14, 2023. Following the release, the companys management will host a conference call and live webcast to discuss the financial results, provide corporate updates, and answer questions. The companys proprietary nicotinamide (NAM) technology is used to create allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies.
Public Trading
growth-positive
Data Published in Transplantation and Cellular Therapy Suggest Antiviral Protection After Transplantation with Gamida Cell’s Omisirge® (omidubicel-onlv)
Gamida Cell Ltd. announced the publication of a prospective sub-study of the Phase 3 clinical trial for Omisirge, the company’s allogeneic stem cell transplant therapy. The study found that Omisirge facilitates faster immune reconstitution than umbilical cord blood (UCB), which may account for the reduced rate of viral infections observed after transplantation with Omisirge versus UCB. The study also found that Omisirge recipients demonstrated an up to 70-fold advantage over patients who received UCB in median cell counts across most cell populations, occurring predominantly in the short-term post-transplantation setting.
Customers
growth-positive
STAND UP TO CANCER NAMES JULIAN ADAMS, Ph.D., CHIEF SCIENCE OFFICER
Stand Up To Cancer (SU2C) has appointed Julian Adams, Ph.D., a veteran oncology researcher and retired pharmaceutical industry executive, as its first Chief Science Officer. In this role, Dr. Adams will lead the development of strategic research priorities to enhance SU2Cs research portfolio. He will also work closely with the SU2C Scientific Advisory Committee to steer funding to the most promising translational research opportunities. Dr. Adams will also support the securing of gifts, grants, and sponsorships that advance SU2Cs distinctive brand of cutting-edge and disruptive research.
Management Changes
growth-positive
Here's Why Gamida Cell (GMDA) Looks Ripe for Bottom Fishing
Gamida Cells stock has been in a downtrend, but there are indications of a potential trend reversal. A hammer chart pattern has formed, suggesting that the bears may have lost control and a turnaround is possible. Additionally, there has been an upward trend in earnings estimate revisions for Gamida Cell, which is a bullish indicator. The consensus EPS estimate for the current year has increased, and the company has a Zacks Rank #2 (Buy), indicating positive prospects. The Zacks Rank has proven to be a reliable timing indicator for identifying when a companys prospects are improving. Overall, there is optimism among Wall Street analysts about Gamida Cells future earnings, enhancing the prospects of a trend reversal for the stock.
Customers
growth-positive
Gamida Cell To Host Investor Day
Gamida Cell Ltd. will host an Investor Day on June 29, 2023, in New York City. The event will feature presentations by thought leaders in stem cell transplant and the Gamida Cell executive team. The team will discuss Omisirge, which was approved by the U.S. Food and Drug Administration for patients with hematologic malignancies who are planned for allogeneic hematopoietic stem cell transplantation. The event is intended for institutional investors, sell-side research analysts, and business development professionals.
Investment
growth-positive
Gamida Cell (GMDA)'s Technical Outlook is Bright After Key Golden Cross
Gamida Cell Ltd. (GMDA) is showing promising signs from a technical perspective, as the companys 50-day simple moving average recently crossed above its 200-day simple moving average, a pattern known as a golden cross. This pattern often indicates a bullish breakout could be on the horizon. GMDAs stock has moved 8.4% higher over the last four weeks, and the company currently holds a #3 (Hold) on the Zacks Rank. The companys positive earnings outlook for the current quarter further strengthens the bullish case.
Data To Be Presented on Gamida Cell Natural Killer (NK) Cell Therapy Candidate GDA-201 at the International Society for Cell & Gene Therapy 2023 Annual Meeting
Gamida Cell to Present Corporate Highlights at the Jefferies Healthcare Conference
Gamida Cell Appoints Terry Coelho as CFO
growth-negative
Breakeven On The Horizon For Gamida Cell Ltd. (NASDAQ:GMDA)
Gamida Cell Ltd., a clinical-stage biopharmaceutical company, is experiencing financial losses and has negative equity. Analysts expect the company to breakeven in 2024 and turn a profit in 2025. The companys growth rate is projected to be 72% annually. The article advises readers to conduct a deeper analysis of Gamida Cells historical track record and management team. It also mentions that the article is not financial advice and does not consider the latest company announcements.
Investment
Gamida Cell Reports First Quarter 2023 Financial Results and Provides Company Update
Gamida Cell Announces the Date of Its First Quarter 2023 Financial Results and Webcast
growth-positive
Insiders who bought into Gamida Cell Ltd. (NASDAQ:GMDA) earlier this year might wish they'd invested more as stock gained 113%
Gamida Cell Ltd. insiders who purchased shares in the last 12 months have seen significant returns, with the stock climbing by 113% and adding US$69m to the company’s market value. The largest single purchase by an insider was when Robert Blum bought US$78k worth of shares at a price of US$1.55 per share. The current price is US$1.60. While insiders have bought shares over the last year, they have not sold any. However, the level of insider ownership is low, with insiders owning about US$913k worth of shares.
Investment
growth-positive
אחרי הזינוק: גמידה סל תגייס 23 מיליון דולר, כת”ב תדולל
שיכון ובינוי is selling shares of its real estate company to an institutional body for a total of 400 million shekels. The CEO of the company, Tamir Cohen, stated that this move is another step towards strengthening the capital and improving the balance.
Investment
Gamida Cell Announces Pricing of $23 Million Public Offering of Securities
Gamida Cell Announces Launch of Public Offering of Securities
growth-positive
Gamida Cell surges after FDA approves cancer treatment
The US Food and Drug Administration (FDA) has approved a cancer treatment of Israeli company Gamida Cell. The companys share price soared nearly 40% in response to the announcement. Gamida Cells product, Omisirge, has shown to shorten treatment times and reduce risks in stem cell transplant therapies. The company plans to market the product independently among clinics in the US. Gamida Cell believes the product will gain additional market share among candidates for umbilical cord blood transplantation. The company recently announced layoffs and the suspension of development of other products in its pipeline. Gamida Cells advantage is its small market, but it believes the product could be relevant to 10,000 patients a year. The company will have to price its product high and may need to finance some procedures initially to help gain momentum.
CustomersInvestment
Gamida Cell (GMDA) Surges on FDA Approval for Omisirge
Gamida Cell's Allogeneic Cell Therapy Omisirge® (omidubicel-onlv) Receives FDA Approval
Gamida Cell’s Allogeneic Cell Therapy Omisirge® (omidubicel-onlv) Receives FDA Approval
Gamida Cell Ltd. (NASDAQ:GMDA) Q4 2023 Earnings Call Transcript
growth-negative
Israeli-Boston cell therapy firm lays off nearly one-fifth of workforce
An Israeli-Boston cell therapy firm is laying off nearly one-fifth of its workforce and putting three drug programs aside.
Layoffs
Gamida Cell Reports Full Year 2022 Financial Results and Provides Company Update
Gamida Cell Announces the Date of Its Fourth Quarter and Full Year 2022 Financial Results and Webcast
Gamida Cell Announces Changes to Board of Directors
Gamida Cell Ltd.'s (NASDAQ:GMDA) largest shareholders are retail investors with 44% ownership, institutions own 29%
Gamida Cell to Present Corporate Highlights at the Oppenheimer 33rd Annual Healthcare Conference
Data Presented on Gamida Cell’s Omidubicel, GDA-201 at the 2023 Tandem Meetings of ASTCT and CIBMTR
growth-positive
Gamida Cell Announces Omidubicel Data To Be Presented as an Oral Presentation at 64th ASH Annual Meeting
Gamida Cell Ltd., a leader in the development of NAM-enabled cell therapy candidates for patients with hematological and solid cancers and other serious diseases, has announced an oral presentation of a real-world analysis comparing the effectiveness of omidubicel to other allo-HCT donor sources from the Center for International Blood and Marrow Transplant Research (CIBMTR) database. The data are being presented at the 64th American Society of Hematology (ASH) Annual Meeting. The analysis showed that omidubicel was associated with more rapid neutrophil recovery compared to all other donor sources. The BLA for omidubicel has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023.
InvestmentExpand
Long-Term Data from Omidubicel Phase 3 Trial Demonstrates Overall Survival and Sustainable Durable Outcomes for Patients with Blood Cancers at the Society of Hematologic Oncology Meeting
Gamida Cell Announces Dosing of First Patient in Company-Sponsored Phase 1/2 Study of NK Cell Therapy Candidate GDA-201
Gamida Cell Announces FDA Acceptance of Biologics License Application for Omidubicel with Priority Review
Gamida Cell Completes Rolling Biologics License Application Submission to the FDA for Omidubicel
Gamida Cell Provides Update on Omidubicel BLA Submission
Gamida Cell Announces Appointment of Senior Vice President, Global Operations and Manufacturing and Provides Commercial Manufacturing Update
Gamida Cell Announces Results from Phase 3 Study of Omidubicel to be Presented at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT)
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Gamida Cell announces $75 million financing with Highbridge Capital Management
Gamida Cell Ltd., an advanced cell therapy company, has announced the sale of $75 million of exchangeable senior notes to funds managed by Highbridge Capital Management. This funding, combined with the proceeds from the companys previous sale of ordinary shares, will provide Gamida Cell with sufficient liquidity to fund its operations until the second half of 2022. The funds will be used to support manufacturing, regulatory and commercial development activities for omidubicel, as well as the preclinical and clinical development of GDA-201, an innate natural killer (NK) cell immunotherapy. The financing strengthens Gamida Cells financials and allows them to advance their therapies to patients.
Investment
growth-positive
גמידה סל מצטרפת למדד הביוטכנולוגיה של ה-Nasdaq
גמידה סל, a biotechnology company, has joined the NBI index on the NASDAQ stock exchange. The company is expecting FDA approval for its drug omidubicel in the fourth quarter of 2021. Omidubicel is a stem cell therapy for cancer and rare bone marrow diseases. The company has completed a Phase III trial with positive results and is preparing to submit a Biologics License Application to the FDA. Omidubicel is also being tested in a clinical trial for severe aplastic anemia. The company is anticipating treating around 2,000 patients per year in the US with omidubicel. The preparations for the drugs launch are underway, with the expectation of FDA approval in the fourth quarter of 2021.
InvestmentPublic Trading
Gamida Cell Announces Launch of Public Offering of Ordinary Shares
growth-positive
Gamida Cell and Be The Match BioTherapies® Expand Strategic Collaboration BioSpace
Gamida Cell and Be The Match BioTherapies have announced an expansion of their strategic collaboration for omidubicel, Gamida Cells advanced cell therapy in Phase 3 clinical development. The collaboration aims to manage the supply chain for the potential commercialization of omidubicel, a potentially life-saving treatment option for patients in need of an allogeneic hematopoietic stem cell transplant. The expanded agreement will involve Be The Match BioTherapies providing cellular source material and logistics management services for omidubicel. This collaboration is a significant step for Gamida Cell in its preparation for potential FDA approval and increasing patient access to omidubicel. Omidubicel is designed to serve as a universal alternative to existing donor sources for bone marrow transplant.
PartnersCustomers
growth-positive
https://www.jpost.com/health-science/israeli-company-sees-promising-results-in-blood-cancer-treatment-trial-645311
Gamida Cell Ltd. announced that its phase III study of Omidubicel, a bone marrow transplant graft treatment, had met all of its secondary endpoints. Omidubicel has already received Breakthrough Therapy Designation from the FDA and could be the first treatment of its kind to hold FDA approval. The treatment has the potential to serve as a graft even if the patient does not have a suitable donor, using stem cell therapies. The study tested the safety and effectiveness of the drug in patients with blood cancers undergoing bone marrow transplants. Gamida Cell CEO Dr. Julian Adams expressed confidence in the potential of Omidubicel and plans to submit a biologics license application to the FDA in the fourth quarter.
CustomersInvestment
growth-positive
Gamida Cell Announces Two-Part Virtual Miniseries Focused on Omidubicel to Take Place in September
Gamida Cell Ltd., a cell therapy company, announced it will host a two-part virtual miniseries in September on key topics related to omidubicel, an advanced cell therapy in Phase 3 clinical development for patients in need of a bone marrow transplant. The company reported in May that its Phase 3 study of omidubicel met its primary endpoint, demonstrating a significant reduction in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. Gamida Cell expects to present the full data set at a medical meeting in Q4 2020 and begin submitting the biologics license application for omidubicel to the FDA.
Investment
growth-positive
Gamida Cell raises $60m at 24% discount
Israeli cell therapy company Gamida Cell Ltd. has raised $60 million to fund the launching of its first product omidubicel for the treatment of high-risk hematologic malignancies. The company recently announced positive Phase III results for Omnidubicel and is confident in receiving marketing approval for the treatment. Gamida Cell issued 13,333,334 ordinary shares at a public offering price of $4.50 per share, with the underwriters having the option to purchase additional shares. The funds will also be used for the continued clinical development of product candidates, expansion of manufacturing capabilities, and general corporate purposes. Gamida Cells shareholders include Novartis, Access Medical, Clal Biotechnology Industries Ltd., Elbit Medical Technologies, and Fidelity Fund.
Investment
growth-positive
Bone marrow co Gamida Cell reports positive Phase III results
Israeli cell therapy company Gamida Cell reported positive results from its Phase III clinical study for omidubicel, a potential life-saving treatment for patients in need of bone marrow transplant. The study found that omidubicel resulted in faster neutrophil engraftment compared to the comparator group. Gamida Cell plans to submit its biologics license application for omidubicel to the FDA in the fourth quarter of this year.
Customers
growth-negative
Gamida Cell raises $35m;share plummets 30%
Israeli company Gamida Cell completed a $35 million financing round at a share price of $5, lower than its initial plan of $7.40 per share. The companys share price dropped 33% on the day of the announcement. Gamida Cell is developing a stem cell-based treatment for blood cancer and is currently in the final stages of a phase III clinical trial for its leading product, Omidubicel. The company recently signed a production agreement with Lonza, a Swiss production company. The funds raised will be used for production capabilities and development of additional products in Gamida Cells pipeline.
InvestmentPartners
growth-positive
Gamida Cell, Lonza establish commercial manufacturing agreement for omidubicel - Pharmaceutical Business review
Gamida Cell and Lonza have entered into a strategic manufacturing agreement for the future commercial production of omidubicel, Gamida Cells advanced cell therapy. The agreement allows Gamida Cell to have access to Lonzas manufacturing site and increase the number of production suites over time. This partnership aims to support Gamida Cell in bringing omidubicel to patients in a commercial setting after potential FDA approval. Lonza, an integrated solutions provider, will construct and dedicate production suites at its Geleen, NL site for the anticipated commercial launch.
Partners
Gamida Cell Bolsters Management Team with Appointment of Tracey Lodie, Ph.D., as Chief Scientific Officer BioSpace
Gamida Cell Announces Data for Omidubicel Presented at the International Society for Cellular and Gene Therapy 2019 Annual Meeting
Gamida Cell Nominates Two Healthcare Industry Veterans to Its Board of Directors
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Gamida Cell Presents New Data from Ongoing Phase 1 Study of NAM-NK and Initial Data from Phase 1/2 Study of NiCord® in Severe Aplastic Anemia at 2019 TCT Annual Meeting BioSpace
Gamida Cell has announced new data from its NAM-NK and NiCord programs, which were presented at a conference. The data showed positive results for NAM-NK, an investigational cell-based cancer immunotherapy, in patients with non-Hodgkin lymphoma and multiple myeloma. The therapy was highly active, with complete responses observed in some patients. The safety data also showed that NAM-NK was well tolerated. Gamida Cell plans to initiate a multi-center, Phase 1/2 clinical study of NAM-NK in 2020. Additionally, data from the ongoing Phase 1/2 study of NiCord, an investigational advanced cell therapy for hematopoietic stem cell transplant, showed successful results in patients with severe aplastic anemia. The rapid engraftment and sustained hematopoiesis observed in these patients support further exploration of NiCord as a bone marrow transplant solution.
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Gamida Cell Announces Agreement with Editas Medicine to Evaluate Use of CRISPR Genome Editing Technology in NAM-NK Cells BioSpace
Gamida Cell has announced an agreement with Editas Medicine to evaluate the potential use of Editas Medicines CRISPR technology to edit NAM-NK cells. The companies aim to discover optimized NAM-NK cells that could be used to improve the treatment of hematologic malignancies and solid tumors. Gamida Cells CEO expressed optimism about the early data generated in the Phase 1 study of NAM-NK as an investigational therapy. The agreement allows for joint research to evaluate unnamed targets by combining Gamida Cells proprietary NAM-based cell expansion technology with Editas Medicines CRISPR technology. The goal is to enhance the efficacy of NAM-NK cells through CRISPR editing and potentially bring life-changing immunotherapy treatments to patients.
Partners
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Gamida Cell, Be The Match BioTherapies Team Up on NiCord for Blood...
Gamida Cell has partnered with Be The Match BioTherapies to expand the use of bone marrow transplants for treating blood cancers. The collaboration aims to make Gamidas investigational cell therapy, NiCord, a universal bone marrow donor source and improve outcomes for transplant patients. Be The Match BioTherapies will provide support in the ongoing development program for NiCord, including a Phase 3 clinical trial. The partnership leverages Be The Match BioTherapies expertise in cellular therapy to advance Gamida Cells clinical development and product delivery efforts. The collaboration is expected to increase the number of bone marrow transplants, addressing the issue of eligible patients not receiving transplants due to difficulties in finding matched donors. NiCord, which uses cells from umbilical cord blood, has been granted breakthrough status and orphan drug designation for high-risk blood cancer patients in need of blood stem cell transplants.
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Gamida Cell Announces Data from NAM-NK and NiCord® Programs to Be Presented at 2019 TCT Annual Meeting
https://www.marketwatch.com/press-release/gamida-cell-and-be-the-match-biotherapies-announce-strategic-collaboration-2019-01-22
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Gamida Cell raises $50m in Nasdaq IPO
Israeli cellular and immune therapeutics company Gamida Cell completed its IPO on Nasdaq, raising $50 million at a valuation of $165 million. The company offered 75% more shares than originally planned at a lower share price of $8. Novartis and Len Blavatniks Access fund were among the investors. Gamida Cell is a clinical stage biopharmaceutical company developing cell therapies for cancer and hematologic diseases.
Public TradingInvestment
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Novartis to invest in $60m Gamida Cell Nasdaq IPO
Gamida Cell, an Israeli stem cell cancer therapy developer, has filed a revised public registration statement with the US Securities and Exchange Commission (SEC) to raise $50-60 million on Nasdaq at a company valuation of $275 million. The companys shareholders, including Novartis, will invest $30 million in the offering. Gamida Cell is a clinical stage biopharmaceutical company that leverages its proprietary technology to develop cell therapies for cancer and rare hematologic diseases. Their most advanced product candidate, NiCord, is a NAM-expanded cord blood cell therapy with the potential to serve as a universal curative stem cell graft. Gamida Cell is currently enrolling patients in a Phase III clinical trial for various hematologic malignancies. To date, the company has raised over $100 million.
Public TradingInvestment
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Biotech Company Gamida Cell Files for $69 Million Nasdaq IPO
Jerusalem-based company Gamida Cell has filed for a $69 million IPO on Nasdaq. The company develops cellular and immune therapies, with its lead product being a universal bone marrow transplant solution called NiCord. Gamida Cell is currently in phase 3 clinical trials for NiCord and has received orphan drug designation from the FDA. The IPO is being managed by BMO Capital Markets and RBC Capital Markets. Gamida Cell has made recent changes to its executive roster, including the appointment of Jaren Madden as VP of Investor Relations and Corporate Communications.
Public TradingManagement Changes
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Gamida Cell files for Nasdaq IPO
Gamida Cell, a joint subsidiary of Clal Biotechnology Industries Ltd. and Elbit Medical Technologies, has submitted a prospectus to the US Securities and Exchange Commission (SEC) for an IPO on Nasdaq. The company is seeking to raise $50-75 million at a company value of $300 million. Gamida Cell is developing stem cell-based products, with its first product, NiCord, designed for the treatment of blood cancer, successfully passing Phase I/II clinical trials. The company has raised over $100 million to date, with its most recent financing round in June 2017 raising $40 million at a company value of $150 million. Gamida Cells technology has the potential to improve treatment for blood cancer and genetic diseases.
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Press Releases - Investors - Gamida Cell Ltd.
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Gamida Cell reports positive cancer drug trial
Gamida Cell, a cancer treatment company, is preparing for an IPO next year after raising money at a $160 million company value. The company recently published the results of its Phase I/II clinical trial for its NiCord product, which showed promising outcomes. Gamida Cell is on a fast track for approval by the US Food and Drug Administration (FDA) and is conducting a Phase III trial of the product. The company also presented results from preclinical trials indicating the potential of its NAM technology in improving the effectiveness of natural killer cells in immunotherapy for various types of cancer. Gamida Cell aims to hold an IPO in 2018 and expects the results from the smaller trial to support its IPO plans.
InvestmentPublic Trading
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Gamida Cell Announces $3.5 Million Grant from the Israeli Government
Gamida Cell has been awarded a grant of $3.5 million from the Israel Innovation Authority. The grant, combined with a recent $40 million financing round, will support Gamida Cells ongoing research and development efforts. The funding will be used for the development and commercialization of NiCord®, as well as other pipeline programs. Gamida Cell is a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases.
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Gamida Cell Inc. Names Ronit Simantov, M.D. as Chief Medical Officer
Gamida Cell has announced the appointment of Dr. Ronit Simantov as its new Chief Medical Officer. Dr. Simantov will play a central role in the late stage development program and commercialization of NiCord, a cellular therapy for the treatment of cancer and orphan genetic diseases. The company is currently enrolling patients in a Phase 3 registration study for NiCord, which has received FDA Breakthrough Therapy Designation. The appointment of Dr. Simantov is part of Gamida Cells plan to establish a U.S. executive presence and transition into a global commercial organization. The company recently secured $40 million in financing. Gamida Cells pipeline includes other cellular and immune therapies for various conditions.
Management ChangesInvestment
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Israel's Gamida Cell raises $40 million for bone marrow trial
Gamida Cell, an Israeli company developing cellular therapies, has raised $40 million to finance the advanced trial of its product NiCord for bone marrow transplants. The funding round was led by new investor Shavit Capital, with participation from VMS Investment Group, Israel Biotech Fund, and existing investor Novartis. Gamida Cell plans to use the funds to complete NiCords Phase 3 clinical trial, expand its manufacturing capacity and presence in the United States, and develop other products. The company is enrolling patients in a Phase 3 study of NiCord as a graft for bone marrow transplants for patients with blood cancer.
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Investment fund leading $30m Gamida Cell round
Gamida Cell, an Israeli stem cell cancer treatment company, has signed a memorandum of understanding with a mezzanine investment fund. The fund will lead a $30 million investment round in Gamida Cell, valuing the company at $120 million. Novartis, which currently has a 20% stake in Gamida Cell, will also participate in the financing round. Gamida Cell is about to commence Phase III clinical trials for its leading product, Nicord, and believes that one trial will be enough for registering the product for marketing. In addition, Teva Pharmaceutical Industries has sold its stake in Gamida Cell to Clal Biotechnology, while increasing its holding in Clal Biotechnology.
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http://www.gamida-cell.com/press_item.asp?ID=71&t=Gamida-Cell-Presents-Positive-Data-From-Phase-1/2-Study-of-NiCord%C2%AE-as-a-Curative-Treatment-for-Sickle-Cell-Disease-at-ASH-2016
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גיוס: Gamida Cell הישראלית מגייסת 15 מיליון דולר מ-Novartis
Novartis, the Swiss pharmaceutical giant, announced that it will invest an additional $15 million in the Israeli biotech company Gamida Cell. Gamida Cell develops stem cell-based therapies for cancer patients and autoimmune diseases. The latest investment reflects a valuation of $200 million for the Israeli company. Gamida Cell uses cord blood stem cells for its treatments, providing a therapeutic option for patients without a suitable donor. The companys products, StemEx and NiCord, enrich the cord blood with stem cells and improve their functionality in bone marrow. Novartis previously acquired a 15% stake in Gamida Cell in 2014 for $35 million, with an option to acquire the company fully for up to $600 million.
Investment
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Gamida Cell Closes $10m Series E Financing - FinSMEs
Gamida Cell has closed a $10m Series E financing round, with participation from major shareholders. The funding will be used for the global commercialization of its lead cell therapy product, StemEx, and the continued development of its pipeline of products. Gamida Cell is seeking a strategic partner to join in the global commercialization of StemEx. The company plans to launch StemEx in 2013.
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Gamida Cell raises $16m in fourth financing round
Israeli start-up Gamida-Cell Ltd. has raised $16 million in a fourth financing round led by Israel Healthcare Ventures Ltd. The capital will be used to support its cell tissue regeneration product pipeline, including the advancement of its cardiac regeneration product and the planned clinical testing of its flagship product StemEx for indications other than hematological diseases. StemEx, developed in partnership with Teva, aims to assist in bone-marrow transplantation for patients with leukemia and lymphoma. Gamida-Cell plans to begin a global pivotal study of StemEx in the near future and bring it to market in partnership with Teva in 2009.
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