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 (NASDAQ: GMDA) announced promising data on GDA-201, its nicotinamide (NAM)-enabled NK cell therapy, enhancing tumor reduction and cytotoxicity. The data will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting from November 10-14, 2021. NAM increases NK cell effectiveness by modulating metabolic pathways and down-regulating immune checkpoints. Gamida Cell's research utilized artificial intelligence to analyze over 1,200 genes and 100 metabolites, showcasing NAM's potential to improve clinical outcomes. GDA-201 targets hematologic and solid tumors while being in ongoing clinical trials.
Gamida Cell Ltd. (NASDAQ: GMDA) will host a conference call on November 15, 2021, at 8:00 a.m. ET to discuss its third quarter 2021 financial results and company updates. The call will be accessible via the Investors & Media section of the Gamida Cell website. Gamida Cell is focused on advanced cell therapies for blood cancers and serious blood diseases, utilizing a proprietary expansion platform to develop therapies that could redefine care standards.
Gamida Cell Ltd. (Nasdaq: GMDA) announced four presentations at the upcoming 63rd American Society of Hematology Annual Meeting held from December 11-14, 2021, in Atlanta, Georgia. Key data on omidubicel, a potential treatment for blood cancer patients needing stem cell transplants, will be featured, showcasing its benefits over standard umbilical cord blood transplantation. Additionally, details on GDA-201, an NK cell immunotherapy, will also be presented. These presentations highlight Gamida's advancements in cell therapies aimed at improving patient outcomes.
Gamida Cell (NASDAQ: GMDA) announced promising early-stage data for two NK cell therapies, GDA-501 and GDA-301, presented by Dr. Aviad Pato at the PEGS Europe conference in Barcelona, Spain, from November 2-4, 2021. GDA-501 targets HER2-overexpressing cancers, demonstrating enhanced potency against tumor cells. GDA-301, featuring CRISPR/Cas9 gene editing, showed cytotoxic activity against chronic myelogenous leukemia and multiple myeloma cell lines. This research highlights Gamida Cell's advancements in NK cell immunotherapy.
Gamida Cell Ltd. (NASDAQ: GMDA) has filed an IND application for its lead therapy GDA-201, which is now on Clinical Hold by the FDA due to required modifications. The company aims to resolve these issues promptly. In a recent virtual R&D Day, Gamida showcased its NAM-enabled NK cell therapy programs, including a collaboration with Dana-Farber Cancer Institute on GDA-601 for multiple myeloma. The updates highlighted the company's advancements in NK cell therapies, targeting hematological cancers and solid tumors, showcasing promising initial clinical results.
Gamida Cell (NASDAQ: GMDA) announced that data on its NAM-enabled NK cell platform will be presented at the Society for Immunotherapy of Cancer's 36th Annual Meeting (SITC 2021) from November 10-14, 2021, in Washington, DC, and virtually. Key presentations include findings on GDA-201's cytotoxicity and tumor-killing capabilities of nicotinamide-enhanced NK cells. GDA-201 is an investigational NK cell immunotherapy targeting hematologic and solid tumors, showing promising initial clinical trial results.
Gamida Cell Ltd. (Nasdaq: GMDA) announced a virtual event on October 26, 2021, at 8:00 a.m. ET, focusing on its NAM-enabled NK cell therapy pipeline. The company will present updates on GDA-201, its leading cell therapy candidate for blood cancers, and new genetically modified NK cell therapies targeting solid tumors and hematological cancers. Featured speakers include Dr. Jeff Miller and Dr. Veronika Bachanova from the University of Minnesota. A link to the event and a subsequent recording will be available on Gamida Cell's website.
Gamida Cell Ltd. (NASDAQ: GMDA) announced upcoming presentations at two virtual investor conferences in September 2021. The presentations include participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15 and the Baird’s 2021 Global Healthcare Conference on September 14. Additionally, Gamida Cell targets a BLA submission for omidubicel by year-end 2021, potentially the first cell therapy approved for blood cancer patients needing allogeneic bone marrow transplants. An IND submission for GDA-201 is also planned for Q3 2021.
Gamida Cell Ltd. (Nasdaq: GMDA) reported a net loss of $21.3 million for Q2 2021, up from $15.1 million in Q2 2020. The company has $150.2 million in cash as of June 30, 2021, which is expected to fund operations into H2 2022. Key advancements include plans for a Biologic License Application (BLA) submission for omidubicel by year-end and the initiation of a Phase 1/2 trial for GDA-201 in non-Hodgkin lymphoma. Gamida is also expanding its NK cell pipeline targeting various cancers. Overall, the company is advancing its commercial readiness and development efforts.
Gamida Cell Ltd. (Nasdaq: GMDA) announced its conference call and live audio webcast on August 11, 2021, to review Q2 2021 financial results and company updates. Key topics include progress on omidubicel, a promising cell therapy aimed at blood cancer patients, with a projected Biologics License Application (BLA) submission in Q4 2021. Additionally, an IND submission for GDA-201 in lymphoma clinical studies is planned. These developments highlight Gamida Cell's commitment to innovative treatments in blood cancers.
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