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Gamida Cell Ltd. - GMDA STOCK NEWS

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.

Rhea-AI Summary
Gamida Cell announces a restructuring process with Highbridge Capital Management, converting $75 million of debt into equity and receiving $30 million in new capital. The company will become private, cancel outstanding shares, and issue contingent value rights. Omisirge® commercialization progresses with 17 transplant centers onboarded in 2023 and confirmed payer coverage exceeding 90%. Revenue for six units of Omisirge delivered in 2023. Positive data from Expanded Access Program and Phase 1 study of GDA-201 presented at conferences.
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Gamida Cell (Nasdaq: GMDA) is set to receive significant new capital from Highbridge to enhance the commercialization of allogeneic stem cell transplant Omisirge®. The company will become private under Highbridge ownership post Israeli court approval. The restructuring agreement with Highbridge will provide Gamida Cell with a long-term financial runway, including a $30 million capital infusion and conversion of $75 million of Highbridge's existing note into equity. Gamida Cell will issue contingent value rights worth up to $27.5 million to ordinary shareholders. The transaction aims to support the ongoing efforts to make Omisirge available to more transplant centers and patients in need.
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Gamida Cell (Nasdaq: GMDA) will release its financial results for Q4 and full year 2023 on March 27, 2024. The company will host a conference call and webcast to discuss the results and provide a business update.
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Gamida Cell Ltd. presents promising data on omidubicel and GDA-201 cell therapies at the 2024 Tandem Meetings, showcasing positive outcomes in hematopoietic recovery and anti-tumor activity. Omidubicel's expanded access program aligns with Phase 3 results, demonstrating rapid recovery and low infection rates post-transplant. GDA-201 Phase 1 data reveal encouraging anti-tumor responses in non-Hodgkin lymphoma patients, with no severe adverse events reported.
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Gamida Cell Ltd. (Nasdaq: GMDA) is pursuing strategic alternatives to maximize value for stakeholders, focusing on an asset sale, merger, or other strategic transaction. The company also continues to prioritize the commercialization of Omisirge® (omidubicel-onlv), the first and only FDA-approved nicotinamide modified cell therapy donor source for allogeneic stem cell transplant.
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Gamida Cell Ltd. (Nasdaq: GMDA) to present new data on FDA approved Omisirge® and allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings. The meetings will take place virtually and in person at the Henry B. González Convention Center in San Antonio, Texas, February 21-24.
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Gamida Cell Ltd. (GMDA) to host virtual fireside chat with thought leader Dr. Gary Schiller, discussing allogeneic stem cell transplant and Omisirge®. Event details and replay information provided.
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Gamida Cell Ltd. (Nasdaq: GMDA) to Present Corporate Highlights at Piper Sandler 35th Annual Healthcare Conference in New York, NY. The company's management team will participate in a fireside chat and be available for one-on-one meetings. Interested investors can contact their Piper Sandler representative for more information.
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Gamida Cell Ltd. (Nasdaq: GMDA) reports initial revenue from Omisirge® (omidubicel-onlv) following FDA approval, with 17 transplant centers onboarded, exceeding 2023 targets. Market access efforts have achieved coverage with more than 90% of commercial lives and all top U.S. commercial payers. Revenue from 4-6 units projected for full year 2023. Lean launch effort to continue in 2024 due to resource constraints.
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Gamida Cell Ltd. shared new data on the impact of their proprietary nicotinamide (NAM) technology on their allogeneic stem cell therapy omidubicel and investigational natural killer (NK) cell therapy candidate GDA-201. Omidubicel was approved by the U.S. FDA for allogeneic stem cell transplant. The data presented at the Society for Immunotherapy of Cancer’s Annual Meeting demonstrate the unique cellular composition of omidubicel and the active phenotype of GDA-201 NK cells expanded in the presence of NAM.
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FAQ

What does Gamida Cell Ltd. do?

Gamida Cell Ltd. is a leader in cellular and immune therapeutics, developing advanced cell therapies for cancer and rare genetic diseases using its proprietary NAM technology platform.

What is Omisirge™?

Omisirge™ (omidubicel-onlv) is an FDA-approved, nicotinamide-modified allogeneic hematopoietic progenitor cell therapy designed to expedite engraftment and reduce infection rates in patients undergoing umbilical cord blood transplantation.

What is GDA-201?

GDA-201 is an investigational natural killer (NK) cell therapy in Phase 1 trials for treating non-Hodgkin lymphoma. It utilizes NAM technology to enhance NK cell function and anti-tumor activity.

What recent achievements has Gamida Cell reported?

Gamida Cell has reported FDA approval and initial revenue from Omisirge, surpassing transplant center onboarding targets, and presenting promising clinical data at major conferences.

How does the NAM technology platform work?

Gamida Cell's NAM technology enhances and expands cells, creating potent cell therapies that can potentially cure hematologic malignancies by improving cell function and survival.

What are the safety warnings for Omisirge?

Omisirge has a boxed warning for infusion reactions, graft-versus-host disease (GvHD), engraftment syndrome, and graft failure. It is contraindicated in patients with allergies to its components.

What are Gamida Cell's financial conditions?

Gamida Cell has faced financial challenges but is undergoing restructuring with support from Highbridge Capital Management to continue operations and the commercialization of Omisirge.

What is the status of Gamida Cell's operations in Israel?

Despite the Israel-Hamas conflict, Gamida Cell's manufacturing facility in Kiryat Gat remains operational, demonstrating the workforce's dedication to ensuring treatment availability.

How can investors stay updated on Gamida Cell?

Investors can stay updated by visiting Gamida Cell's official website or following the company on LinkedIn, Twitter, Facebook, and Instagram for the latest news and developments.

What future plans does Gamida Cell have?

Gamida Cell plans to expand its clinical pipeline, onboard more transplant centers, and secure additional funding to support the widespread commercialization of Omisirge and development of GDA-201.

Gamida Cell Ltd.

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