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 its participation in the BTIG Virtual Biotechnology Conference on August 10, 2021, at 3:00 p.m. ET, with a live webcast available on BTIG’s site. The company is targeting a BLA submission for omidubicel, marking a potential first approval for a cell therapy for blood cancer patients needing allogeneic bone marrow transplants in Q4 2021. Additionally, an IND submission is planned for a Phase 1/2 study of GDA-201 in lymphoma patients in the second half of 2021.
Gamida Cell Ltd. (Nasdaq: GMDA) announced the publication of results from a Phase 3 clinical study of omidubicel in Blood. This advanced cell therapy aims to improve outcomes for patients with hematologic malignancies. The study demonstrated faster neutrophil and platelet recovery than standard umbilical cord blood grafts, fewer infections, and reduced hospitalization time. Data indicates that omidubicel may become a new standard of care for bone marrow transplants, with plans for a Biologics License Application submission to the FDA in Q4 2021.
Gamida Cell Ltd. (Nasdaq: GMDA) announced its participation in key investor conferences in June 2021. Management will present a corporate overview at the JMP Securities Life Sciences Conference on June 16, focusing on growth opportunities from omidubicel and GDA-201, both promising therapies for blood cancers. Additionally, they will hold one-on-one meetings at the A.G.P. Summer Healthcare Symposium on June 17. The company aims for a BLA submission for omidubicel in Q4 2021 and an IND submission for GDA-201 in late 2021, enhancing treatment options for patients requiring bone marrow transplants.
Gamida Cell Ltd. (Nasdaq: GMDA) appointed Vladimir Melnikov as the new senior vice president of global operations and manufacturing. Melnikov has over 25 years of experience in the biopharmaceutical sector, particularly in biologics manufacturing. His role will focus on Gamida Cell's advanced cell therapy, omidubicel, aimed at treating blood cancers. The company remains on track to submit its Biologics License Application for omidubicel by Q4 2021. They have made significant progress in ensuring manufacturing readiness, with one facility in Israel and a partnership with Lonza for additional production.
Gamida Cell Ltd. (Nasdaq: GMDA) announced that CEO Julian Adams will participate in a fireside chat at the RBC Capital Markets Global Healthcare Conference on May 19, 2021, at 3:40 p.m. ET. The event will be available via live webcast on the company’s website and accessible for at least 14 days afterwards. Gamida Cell focuses on advanced cell therapies for blood cancers and serious blood diseases, utilizing its cell expansion platform to develop innovative treatment options.
Gamida Cell Ltd. (Nasdaq: GMDA) reported its Q1 2021 financial results, highlighting advancements with omidubicel, a potential treatment for blood cancer patients needing bone marrow transplants. The company aims to submit a Biologics License Application (BLA) to the FDA in Q4 2021, following positive Phase 3 clinical data showing a median neutrophil engraftment time of 12 days for omidubicel patients, compared to 22 days for the control group. Gamida Cell also plans to submit an IND for GDA-201 and initiate a Phase 1/2 clinical study for non-Hodgkin lymphoma.
Gamida Cell Ltd. (Nasdaq: GMDA) will host a conference call and live audio webcast on May 11, 2021, at 8:00 a.m. ET to discuss its first quarter 2021 financial results and company updates. Participants can join the call by dialing 866-930-5560 for domestic calls or 409-216-0605 for international calls, using conference ID 5258448. The event is accessible via the "Investors & Media" section of Gamida Cell's website. A replay will be available two hours post-event for 30 days, allowing stakeholders to review key financial insights and strategic directions.
Gamida Cell Ltd. (Nasdaq: GMDA), a leading cell therapy company, announced that CEO Julian Adams, Ph.D., will present at the 20th Annual Needham Virtual Healthcare Conference on April 14, 2021, at 2:15 p.m. ET. This presentation underscores the company's commitment to developing cures for blood cancers and serious blood diseases.
Investors can access a live webcast of the event on the company's website, which will be available for at least 14 days post-event. For more details, visit www.gamida-cell.com.
Gamida Cell Ltd. (Nasdaq: GMDA) announced results from a Phase 3 study of its cell therapy, omidubicel, presented at the EBMT 2021 meeting. The study demonstrated faster hematopoietic recovery, fewer infections, and reduced hospitalization days compared to standard umbilical cord blood transplants. Results showed a median time to neutrophil engraftment of 12 days for omidubicel versus 22 days for the comparator. Gamida Cell plans to submit a Biologics License Application (BLA) to the FDA in Q4 2021, reinforcing the potential of omidubicel in transforming outcomes for patients without matched donors.
Gamida Cell Ltd. (Nasdaq: GMDA) reported its financial results for Q4 and FY 2020, emphasizing advancements in cell therapies like omidubicel and GDA-201. Omidubicel, achieving primary and secondary endpoints in its Phase 3 trial, is set for BLA submission in Q4 2021. The company raised approximately $75 million in late 2020 and February 2021, enhancing its financial position to support ongoing development. Despite a net loss of $72.7 million in 2020, Gamida anticipates a cash runway into H2 2022, targeting commercial readiness and regulatory submissions in 2021.
FAQ
What is the market cap of Gamida Cell Ltd. (GMDA)?
What does Gamida Cell Ltd. do?
What is Omisirge™?
What is GDA-201?
What recent achievements has Gamida Cell reported?
How does the NAM technology platform work?
What are the safety warnings for Omisirge?
What are Gamida Cell's financial conditions?
What is the status of Gamida Cell's operations in Israel?
How can investors stay updated on Gamida Cell?
What future plans does Gamida Cell have?
