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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.

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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.

Nasdaq:GMDA

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