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) provided a business update highlighting productive FDA interactions and preparing for the potential launch of its lead product, omidubicel, ahead of its May 1 PDUFA date. The company reported a net loss of $79.4 million for 2022, improved from $89.8 million in 2021, with cash reserves of $64.7 million. Strategic restructuring will focus on omidubicel and reduce operating expenses, including a 17% workforce reduction. The company aims for commercial partnerships and plans to continue its GDA-201 Phase 1 study while discontinuing its NK cell preclinical candidates. Positive feedback from transplant centers and anticipated payer coverage indicate potential market success.
Gamida Cell Ltd. (NASDAQ: GMDA) announces the appointment of
Gamida Cell Ltd. (Nasdaq: GMDA) will host a conference call on
Gamida Cell Ltd. (NASDAQ: GMDA) announced that CEO Abbey Jenkins will present at the Oppenheimer 33rd Annual Healthcare Conference on March 14, 2023, at 9:20 a.m. ET. The presentation will cover corporate highlights and updates on the lead product candidate, omidubicel, which has a PDUFA action date set for May 1, 2023, from the FDA. Omidubicel is an advanced cell therapy for allogeneic stem cell transplants, designed to improve outcomes for blood cancer patients. The candidate has shown a significant reduction in engraftment times and fewer complications compared to standard treatments. The webcast will be available on Gamida Cell's website for 14 days.
Gamida Cell (NASDAQ: GMDA) has presented new data at the 2023 TCT Meetings, showcasing the efficacy of its leading product candidate, omidubicel, and the NK cell therapy candidate, GDA-201. The data indicates that omidubicel may accelerate immune responses after allogeneic stem cell transplants. Specifically, patients treated with omidubicel showed faster neutrophil and platelet engraftment. For GDA-201, results from an ongoing Phase 1/2 study highlight its potential in treating non-Hodgkin lymphoma, demonstrating significant immune engagement and high cytotoxicity. The PDUFA action date for omidubicel is set for May 1, 2023.
Gamida Cell Ltd. (NASDAQ: GMDA) has successfully closed a $25 million senior secured convertible term loan with Highbridge Capital Management. The loan, maturing on December 12, 2024, will support the commercial readiness and launch preparations for omidubicel, an innovative cell therapy pending FDA approval. The capital will also fund the NK product pipeline and general corporate expenses. Omidubicel may address unmet needs in hematologic malignancies, having shown significant clinical benefits in trials, and has received Breakthrough Therapy Designation from the FDA.
Gamida Cell Ltd. (NASDAQ: GMDA) announced upcoming presentations at two major investor conferences. The 34th Annual Piper Sandler Healthcare Conference will take place on November 29, 2022, with a fireside chat at 1:00 p.m. ET. The Evercore ISI Healthcare Conference is scheduled for December 1, 2022, at 2:15 p.m. ET. A webcast will be available on their website for 14 days post-event. Gamida is advancing omidubicel, a novel cell therapy for blood cancers, with a PDUFA target date of May 1, 2023.
Gamida Cell Ltd. (Nasdaq: GMDA) provided a business update and financial results for Q3 2022, reporting a net loss of $17.8 million, improved from $23.2 million in Q3 2021. The company strengthened its financial position with a $20 million public offering and a $25 million secured loan. Preparations for the commercial launch of omidubicel are underway, with a PDUFA target action date set for January 30, 2023. New data indicates promising long-term survival and quality of life outcomes for patients treated with omidubicel, supporting its anticipated approval for allogeneic stem cell transplants.
Gamida Cell Ltd. (Nasdaq: GMDA) announced that President and CEO Abbey Jenkins will present corporate highlights at the Jefferies London Healthcare Conference on November 17, 2022, at 9:10 a.m. GMT. Key discussion points will include the market opportunity for omidubicel upon potential FDA approval and the accelerated development of GDA-201, targeting hematologic cancers. The presentation will be available via webcast on Gamida Cell's website. Omidubicel has shown promising Phase 3 study results, receiving Breakthrough Therapy Designation and is expected to offer new treatment options to blood cancer patients.
Gamida Cell (NASDAQ: GMDA) will host a conference call and live webcast on November 14, 2022, at 8:00 AM EST to discuss its Q3 2022 financial results and company updates. The call can be accessed via Gamida Cell's website, with a replay available for 30 days post-event. Gamida Cell focuses on developing NAM-enabled cell therapies for hematologic and solid cancers, including the investigational product omidubicel, which is under FDA review as a potential alternative for bone marrow transplants.
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