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) announced a follow-on public offering of its ordinary shares, including a potential 30-day underwriter option to purchase an additional 15% of the shares. The offering is contingent on market conditions, and all shares will be sold by the company. Proceeds from the offering will support the commercial launch of omidubicel, ongoing clinical development of GDA-201, and enhance manufacturing capabilities. The offering's registration has been filed with the SEC and a prospectus will be available through the joint book-running managers.
Gamida Cell Ltd. (Nasdaq: GMDA) announced that it held a Type B Meeting with the FDA regarding its drug omidubicel on December 11, 2020. The FDA provided positive feedback on the Phase 3 study's endpoints but requested additional manufacturing data before a pre-BLA meeting. Gamida Cell plans to submit a full BLA in H2 2021, aiming for a possible omidubicel launch in the U.S. by mid-2022. The drug has already received Breakthrough Therapy and Orphan Drug designations. Positive Phase 1 data for GDA-201 is also expected to lead to an IND submission in 2021.
Gamida Cell Ltd. (Nasdaq: GMDA) provided a significant update on its Phase 3 clinical study of omidubicel during a virtual Pipeline Deep Dive event. The study aims to enhance bone marrow transplantation for blood cancer patients lacking suitable donors. Notable outcomes include a median neutrophil engraftment time of 12 days with omidubicel compared to 22 days for the comparator group, with statistically significant improvements in secondary endpoints such as accelerated platelet engraftment and reduced infection rates. Gamida Cell plans to file a Biologics License Application (BLA) by year-end 2020.
Gamida Cell Ltd. (Nasdaq: GMDA) announced positive updates from a Phase 1 clinical study of GDA-201, an NK cell-based immunotherapy for non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). Presenting at the 62nd ASH Annual Meeting, the study showed no dose-limiting toxicities in 35 patients, with a notable overall response rate of 74% in NHL patients. The therapy demonstrated significant efficacy with 68% achieving complete responses. Gamida plans to advance to a Phase 2 clinical study, aiming for an IND submission in 2021.
Gamida Cell Ltd. (Nasdaq: GMDA) announced a virtual event on December 9, 2020, at 8:00 a.m. ET, focusing on its pipeline, including the Phase 3 clinical trial of omidubicel for bone marrow transplants and GDA-201, a natural killer cell-based cancer immunotherapy. The event will be accessible online, with a replay available for 14 days after. Gamida Cell is dedicated to developing advanced cell therapies to treat blood cancers and serious blood diseases.
Gamida Cell Ltd. (Nasdaq: GMDA), focused on advanced cell therapy for blood cancers, announced CEO Julian Adams will present at two virtual conferences in December 2020. The events are the Evercore ISI 3rd Annual HealthCONx Conference on December 3 at 12:10 p.m. ET, and the Piper Sandler 32nd Annual Healthcare Conference from December 1-3, where the fireside chat will be on-demand. Webcasts will be accessible in the Investors & Media section of their website for at least 14 days following each event.
Gamida Cell Ltd. (Nasdaq: GMDA) reported its Q3 2020 financial results, highlighting significant advances in its therapies. The Phase 3 clinical study of omidubicel met all secondary endpoints, showing promise for bone marrow transplant patients. The company anticipates submitting a biologics license application (BLA) to the FDA in Q4 2020. Additionally, GDA-201 continues in Phase 1 trials with positive outcomes in non-Hodgkin lymphoma patients. Gamida Cell's net loss for Q3 2020 was $14.8 million on expenses of $10.5 million for R&D. The company retains $73.3 million in cash, supporting operations into H2 2021.
Gamida Cell Ltd. (Nasdaq: GMDA) provided updates on its clinical studies at the ASH 62nd Annual Meeting, scheduled from December 5-8, 2020. Key highlights include an oral presentation of data from the Phase 1 trial of GDA-201, targeting non-Hodgkin lymphoma, and a poster presentation of omidubicel’s study in severe aplastic anemia. Previously, a Phase 3 study of omidubicel met its primary endpoint, showing significant improvement in neutrophil engraftment time. Omidubicel is also being evaluated in a Phase 1/2 study for severe aplastic anemia and is filed with the FDA under the brand name CordIn.
Gamida Cell Ltd. (Nasdaq: GMDA) has announced that CEO Julian Adams, Ph.D., will present at the H.C. Wainwright 6th Annual Israel Conference on November 12, 2020, at 11:00 a.m. ET. Investors can access a live webcast of the presentation on Gamida Cell's website, which will remain available for at least 14 days post-event. Gamida Cell focuses on advanced cell therapies targeting blood cancers and serious blood diseases, utilizing a cell expansion platform aimed at redefining care standards in medical need.
Gamida Cell Ltd. (Nasdaq: GMDA) has scheduled a conference call and live audio webcast on November 10, 2020, at 8:30 a.m. ET. This event will review the third quarter 2020 financial results and provide updates on the company's activities. Interested parties can access the webcast via the Investors & Media section of Gamida Cell's website. Participants can join the live call by dialing 866-930-5560 domestically or 409-216-0605 internationally, using conference ID 9998754. A replay will be available for 30 days post-event.
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