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 the pricing of a public offering of 17,500,000 ordinary shares along with warrants for gross proceeds of approximately $22.8 million at a price of $1.30 per share. The warrants, with an exercise price of $1.35, are immediately exercisable and will expire in five years. The offering closing is expected on April 21, 2023, pending customary conditions. The company plans to utilize the net proceeds for the commercialization of Omisirge®, continued development of GDA-201, and general corporate purposes. An additional 2,625,000 shares may be purchased by underwriters within 30 days of the offering. A registration statement has been filed and became effective on April 1, 2022.
Gamida Cell Ltd. (Nasdaq: GMDA) announced a follow-on public offering of its ordinary shares and accompanying warrants, with the potential for underwriters to purchase an additional 15%. The offering is contingent on market conditions, and no completion guarantee is provided. Proceeds will support commercial activities for Omisirge®, continued clinical development of GDA-201, and general corporate purposes. The registration statement for the shares was previously filed and became effective on April 1, 2022. The offering is managed by Piper Sandler & Co..
Gamida Cell Ltd. announces FDA approval of Omisirge (omidubicel-onlv), an allogeneic cell therapy for adult and pediatric patients 12 years and older with hematologic malignancies. This approval is based on a global randomized Phase 3 clinical trial demonstrating significant benefits, including a median time to neutrophil recovery of 12 days versus 22 days for standard cord blood (p<0.001). Furthermore, Omisirge showed a reduced incidence of severe infections (39% vs. 60%). With breakthrough therapy designation and orphan drug designation, Omisirge potentially increases access to transplants, particularly for racially diverse patients. The company is actively onboarding transplant centers and pursuing strategic partnerships for commercialization. A conference call is scheduled for April 18 at 8 am ET.
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