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) has initiated the rolling submission process for its Biologics License Application (BLA) for omidubicel with the FDA. The company is on track to complete the BLA submission in the second quarter of 2022. Omidubicel aims to serve patients with blood cancers who require stem cell transplants, potentially addressing needs for those lacking suitable donors. The Phase 3 study demonstrated significant improvements in engraftment times and reduced hospitalization risks. Omidubicel is positioned to be the first FDA-approved advanced cell therapy for allogeneic transplants.
Gamida Cell Ltd. (Nasdaq: GMDA) announced the appointment of Anat Cohen-Dayag, Ph.D., and Naama Halevi-Davidov, Ph.D., to its Board of Directors as Class II Directors. This move aims to enhance the company's scientific and financial capabilities in advancing its cell therapy pipeline. Dr. Cohen-Dayag brings over 25 years of biotech experience, while Dr. Halevi-Davidov has extensive financial expertise, previously serving as CFO of Kaltura, Inc. These additions are expected to strengthen Gamida Cell's mission to develop innovative cures for serious diseases.
Gamida Cell (NASDAQ: GMDA) has announced the initiation of a rolling BLA submission for its cell therapy omidubicel, expected to be fully submitted by mid-2022. The company is also exploring commercialization partnerships for omidubicel while implementing a 10% workforce reduction to extend its cash runway into mid-2023. The company ended 2021 with approximately $96.1 million in cash, anticipating operational cash use between $60 million and $70 million in 2022. Gamida Cell plans to report its 2021 financial results on March 16, 2022.
Gamida Cell Ltd. (Nasdaq: GMDA) announced plans to initiate a rolling Biologics License Application (BLA) submission for omidubicel after receiving positive feedback from the FDA. The full BLA submission is expected in the first half of 2022. This follows the establishment of analytical comparability between its commercial manufacturing and prior clinical sites. Omidubicel, which has Breakthrough Therapy Designation, represents a potential advancement in stem cell transplantation for blood cancer patients.
Gamida Cell Ltd. (NASDAQ: GMDA) announced eight presentations at the 2022 TCT Meetings from February 2-6, 2022, in Salt Lake City, UT, showcasing new data on its cell therapy, omidubicel. Key highlights include one-year data from a phase 3 study emphasizing lower non-relapse mortality rates (73% vs. 60% vs. standard umbilical cord blood transplantation). Other studies detail omidubicel's potential to enhance health-related quality of life and reduce racial health disparities among patients. Omidubicel is FDA-designated as a breakthrough therapy for blood cancers.
Gamida Cell Ltd. (NASDAQ: GMDA) announced promising two-year follow-up data for GDA-201, a cell therapy for relapsed or refractory non-Hodgkin lymphoma (NHL), showing a median duration of response of 16 months and a two-year overall survival rate of 78%. Additionally, the company revealed that omidubicel treatment significantly reduces hospitalization and healthcare resource utilization compared to standard cord blood transplants. These findings will be presented at the 63rd American Society of Hematology Annual Meeting in Atlanta on December 13, 2021.
Gamida Cell Ltd. (NASDAQ: GMDA) presented significant clinical data on omidubicel at the ASH Annual Meeting in Atlanta (December 11-14, 2021). An oral presentation highlighted rapid recovery of T and B cells in patients, supporting reduced severe infections compared to standard treatments. A poster presentation showed encouraging long-term outcomes from a single-center study with a 10-year follow-up, indicating sustained safety and effectiveness, with an overall survival rate of 48.5%. These findings reinforce omidubicel's potential as a transformative therapy for blood cancer patients.
Gamida Cell Ltd. (Nasdaq: GMDA) announced its participation in several upcoming virtual investor conferences. They will present at the Evercore ISI HealthCONx Conference on November 30, 2021, followed by the Piper Sandler Virtual Healthcare Conference on December 2, 2021, and the JMP Securities Hematology and Oncology Summit on December 6, 2021. A webcast of these events will be accessible through the company’s website for 14 days post-event. Gamida Cell focuses on innovative cell therapies for blood cancers and serious blood diseases.
Gamida Cell Ltd. (Nasdaq: GMDA) reported a net loss of $19.6 million for Q3 2021, up from $14.8 million in Q3 2020. The company has $121 million in cash, and is revisiting financial guidance due to a delayed Biologics License Application (BLA) submission for omidubicel, now expected in the first half of 2022. Data presented at the ASH Annual Meeting demonstrated a 78% overall survival rate at two years for GDA-201 and showed long-term benefits of omidubicel.
Gamida Cell (NASDAQ: GMDA) has completed a Pre-Biologics License Application (BLA) meeting with the FDA for omidubicel, a treatment for blood cancers. The FDA has requested a revised analysis of manufacturing data from Gamida Cell’s facility to ensure comparability with clinical trial products. Despite this delay, the company is optimistic about the feedback and aims to submit the BLA in the first half of 2022, pushing back from the end of 2021. Omidubicel is a breakthrough therapy intended to improve outcomes for patients needing stem cell transplants.
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?
