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 announces the initiation of a Phase 1/2 study for GDA-201, a novel NK cell therapy targeting follicular and diffuse large B-cell lymphomas. This investigational therapy uses a cryopreserved formulation, aiming to improve treatment options for relapsed or refractory lymphoma patients. The Phase 1 segment will assess safety, while Phase 2 will evaluate efficacy in 63 patients. Previous studies showed promising results with a 74% overall response rate. With approximately 40,000 eligible patients in the US and EU, GDA-201 may offer new hope for cancer treatment.
Gamida Cell Ltd. (NASDAQ: GMDA) will host a conference call on August 15, 2022, at 8:00 a.m. ET to discuss its second quarter 2022 financial results. The call will provide updates on the company's ongoing developments, including its innovative cell therapy pipeline targeting hematologic and solid cancers. Gamida Cell continues to advance its proprietary NAM-enabled therapies, including omidubicel, which aims to improve outcomes for patients needing bone marrow transplants. A live audio webcast will be available, with a replay accessible for 30 days.
Gamida Cell announced the acceptance of its Biologics License Application (BLA) for omidubicel, an advanced stem cell therapy, by the FDA. If approved, this will be the first allogeneic stem cell donor source for patients with blood cancers, targeting a PDUFA action date of
Gamida Cell Ltd. (NASDAQ: GMDA) will present corporate highlights at the JMP Securities Life Sciences Conference on June 16, 2022, at 2:00 p.m. ET in New York, NY. The company plans to discuss 2022 catalysts including the U.S. market potential for omidubicel, its advanced cell therapy candidate with Breakthrough Therapy Designation. Additionally, the presentation will cover GDA-201, an NK cell therapy candidate for blood cancers, and the expansion of its cell therapy pipeline. A webcast of the event will be available on their website for 14 days post-presentation.
Gamida Cell Ltd. (NASDAQ: GMDA) announced the appointment of Dr. Ivan M. Borrello to its Board of Directors, effective June 9, 2022. Dr. Borrello, an Associate Professor of Oncology at Johns Hopkins, is recognized for his work in immunotherapies and hematologic malignancies. He replaces Ofer Gonen, who resigns to become CEO of MediWound Ltd. CEO Julian Adams praised Dr. Borrello's expertise, stating it will bolster Gamida's efforts to progress its NAM-enabled cell therapy pipeline, which includes investigational products like omidubicel for blood cancers.
Gamida Cell Ltd. (Nasdaq: GMDA) announced the completion of its rolling Biologics License Application (BLA) submission for omidubicel, an advanced stem cell therapy for patients with blood cancers needing transplants. This milestone is significant as omidubicel aims to be the first approved advanced cell therapy product for allogeneic stem cell transplantation. The BLA is supported by a pivotal Phase 3 study showing omidubicel significantly reduces the time to neutrophil and platelet engraftment compared to standard umbilical cord blood.
Gamida Cell Ltd. (NASDAQ: GMDA) will present corporate highlights at the Jefferies Healthcare Conference on June 8, 2022, at 11:00 a.m. ET in New York. Key discussion points include potential U.S. FDA approval for omidubicel, a life-saving allogeneic stem cell transplant therapy candidate. Management will also cover the development of GDA-201, a novel NK cell therapy for blood cancers. Omidubicel has achieved significant efficacy milestones in clinical trials and aims to improve patient access to transplants. A webcast will be available on the company's website for 14 days post-event.
Gamida Cell (Nasdaq: GMDA) has initiated the clinical trial for GDA-201, a novel cryopreserved cell therapy targeting follicular and diffuse large B cell lymphomas. Following FDA clearance of its IND application, the Phase 1/2 trial aims to enroll patients with relapsed or refractory lymphoma after at least two treatments. Initial trials of GDA-201's fresh formulation yielded a 74% overall response rate. The study is currently active at Henry Ford Health and the University of Minnesota, with plans for additional sites.
Gamida Cell Ltd. (NASDAQ: GMDA) will present at the H.C. Wainwright Global Life Sciences Conference on May 24, 2022, at 7:00 a.m. ET. Management will discuss 2022 catalysts, including the potential U.S. launch of omidubicel upon FDA approval and advancements in GDA-201, a novel NK cell therapy. Omidubicel aims to enhance stem cell transplants for blood cancer patients and has shown significant efficacy in Phase 3 trials. The company’s NAM-enabled technology is designed for better cell function and therapy outcomes. A webcast will be available post-conference.
Gamida Cell Ltd. (Nasdaq: GMDA) announced key updates and Q1 2022 results. The company is set to submit a full Biologics License Application (BLA) for omidubicel in Q2 2022 and plans to commence a Phase 1/2 study for GDA-201 targeting lymphomas. As of March 31, 2022, it reported $69.7 million in cash, sufficient to support operations into mid-2023. The net loss for the quarter was $20.2 million, a slight increase from $19.2 million year-on-year. Gamida Cell also presented promising data on its NK cell therapy candidates at recent conferences.
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