Welcome to our dedicated page for Gamida Cell Ltd. news (Ticker: GMDA), a resource for investors and traders seeking the latest updates and insights on Gamida Cell Ltd. stock.
Gamida Cell Ltd. (Nasdaq: GMDA) is a pioneering company in the field of cellular and immune therapeutics, dedicated to transforming treatment paradigms for cancer and rare genetic diseases. With its headquarters in Boston, Gamida Cell is at the forefront of developing potentially life-saving therapies.
The company's core technology revolves around its proprietary nicotinamide (NAM) platform, which enhances and expands cells to create advanced, allogeneic cell therapies. This innovation has led to the development of several promising products:
- Omisirge™ (omidubicel-onlv): An FDA-approved, nicotinamide-modified allogeneic hematopoietic progenitor cell therapy. Omisirge is designed to facilitate rapid engraftment and reduce infection rates in patients undergoing umbilical cord blood transplantation. This therapy is indicated for adults and pediatric patients with hematologic malignancies.
- GDA-201: An investigational natural killer (NK) cell therapy currently in Phase 1 clinical trials for the treatment of non-Hodgkin lymphoma. GDA-201 leverages NAM technology to enhance NK cell function, showing promising anti-tumor activity.
Gamida Cell has achieved significant milestones, including the FDA's breakthrough therapy designation for its lead program, NiCord®, and the transition to a commercial-stage company with the approval and initial revenue generation from Omisirge. The company continues to expand its reach, with 17 transplant centers onboarded in 2023, surpassing its target range.
Recent data presented at the Society for Immunotherapy of Cancer's Annual Meeting and the 2024 Tandem Meetings further underscore the efficacy and potential of Gamida Cell’s technologies. Omisirge's expanded access program (EAP) results and Phase 1 data for GDA-201 have shown consistent, encouraging outcomes.
Despite financial challenges, Gamida Cell maintains its commitment to delivering innovative therapies. The company has entered into a Restructuring Support Agreement (RSA) with Highbridge Capital Management to ensure continued operations and support for Omisirge's commercialization.
The company's resilience is further demonstrated by its operational continuity amid the Israel-Hamas conflict, showcasing the dedication of its workforce in Kiryat Gat, Israel. Gamida Cell remains focused on making its advanced therapies accessible to more patients, aiming to secure a significant market share for Omisirge and expand its clinical pipeline with ongoing studies for GDA-201.
For more information, visit Gamida Cell's official website or follow the company on LinkedIn, Twitter, Facebook, and Instagram.
Gamida Cell Ltd. (Nasdaq: GMDA) presented significant preclinical data at the International Society for Cell & Gene Therapy conference, showcasing two investigational therapies, GDA-301 and GDA-601. GDA-301 demonstrated enhanced cytotoxicity against hematologic malignancies and solid tumors, while GDA-601 showed superior responses against multiple myeloma cells. The company aims to select a genetically modified NK cell therapy candidate for IND enabling studies by the end of 2022. Both therapies remain investigational and have not yet received FDA approval.
Gamida Cell Ltd. (NASDAQ: GMDA) has scheduled a conference call and live audio webcast for May 10, 2022, at 8:00 a.m. ET, to discuss its Q1 2022 financial results and provide company updates. The event will be accessible via the company's website. Gamida Cell is focused on cell therapies for blood cancers. Its pipeline includes promising therapies like omidubicel, an investigational product aimed at bone marrow transplant patients. Investors are encouraged to stay informed about the company's developments through the webcast and subsequent updates.
Gamida Cell announced updated one-year post-transplant data for its investigational therapy, omidubicel, presented at TCT 2022. The data indicates enhanced overall survival, early engraftment, and reduced infection rates compared to standard umbilical cord blood transplantation (UCBT). Specifically, the one-year overall survival was 73% with omidubicel versus 60% with UCBT, alongside lower non-relapse mortality (23% vs. 18%). Gamida Cell is on track to complete a rolling Biologics License Application for omidubicel in Q2 2022.
Gamida Cell Ltd. (NASDAQ: GMDA) announced that the FDA cleared its IND application for GDA-201, a cryopreserved cell therapy candidate targeting follicular and diffuse large B-cell lymphomas. This milestone allows Gamida Cell to commence a Phase 1/2 clinical study in 2022. Previous studies have shown promising results with GDA-201, including a 74% overall response rate among lymphoma patients. The therapy employs Gamida Cell's NAM technology platform to enhance natural killer cell functionality, aiming to meet the urgent need for effective treatments in this patient population.
Gamida Cell Ltd. (GMDA) presented updated data on its investigational therapy, omidubicel, at the 2022 TCT Meeting. This advanced stem cell therapy showed promising results in immune cell recovery and reduced infection rates compared to standard umbilical cord blood transplantation. The therapy's Biologics License Application (BLA) is on track for completion by Q2 2022. The presentation was awarded the TCT Best Abstract Award, reinforcing omidubicel's potential to transform blood cancer treatment.
Gamida Cell has released a study indicating that the use of omidubicel, an investigational advanced cell therapy, could significantly improve access to allogeneic hematopoietic stem cell transplants, particularly for racial minorities. The study projects that increased omidubicel usage could enhance one-year overall survival rates by up to 6.3% for Black patients, addressing a critical disparity in treatment access. Gamida Cell is on track to complete its Biologics License Application (BLA) submission for omidubicel in Q2 2022.
Gamida Cell Ltd. (Nasdaq: GMDA) announces participation in the 21st Annual Needham Virtual Healthcare Conference on April 12, 2022, at 1:30 p.m. EDT. Management will outline 2022 catalysts, including the U.S. commercial strategy for its allogenic stem cell therapy and progress on GDA-201, its NK cell therapy targeting lymphomas. CEO Julian Adams will also join a panel discussion on April 14, 2022, at 11:00 a.m. EDT. The webcast will be available on Gamida Cell's website for 14 days post-event, reinforcing their commitment to advanced NAM-enabled cell therapies.
Gamida Cell Ltd. (Nasdaq: GMDA) provided a business update on March 15, 2022, highlighting a rolling BLA submission for omidubicel, anticipated to be completed in H1 2022. The company reported a net loss of $89.8 million for 2021, compared to $61.6 million in 2020, with cash reserves of approximately $96 million to fund operations into mid-2023. Gamida Cell is addressing an FDA clinical hold on its GDA-201 IND and advancing its NK cell pipeline. Expected milestones for 2022 include the completion of the BLA and initiation of a Phase 1/2 study for GDA-201.
Gamida Cell Ltd. (Nasdaq: GMDA) will present corporate highlights at the Oppenheimer 32nd Annual Healthcare Conference on March 16, 2022, at 2:00 p.m. ET. The presentation will be accessible via webcast on the company's website for at least 14 days post-event. Gamida Cell is focused on innovative cell therapies targeting blood cancers and serious blood diseases, with a notable investigational product, omidubicel, aimed at improving bone marrow transplant outcomes. The company leverages a proprietary expansion platform to develop potentially curative therapies.
Gamida Cell Ltd. (NASDAQ: GMDA) announced a conference call on March 15, 2022, at 8:00 a.m. ET to discuss its Q4 and full year 2021 financial results and provide a company update. The event can be accessed via the Gamida Cell website. The company is known for its diverse immunotherapy pipeline focused on blood cancers, including its investigational product omidubicel, aimed at providing life-saving alternatives for patients needing bone marrow transplants. Gamida Cell emphasizes its commitment to potential cures for serious blood diseases.
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