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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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Gamida Cell Ltd. (Nasdaq: GMDA) announced participation in two investor conferences in March 2021. The first is the H.C. Wainwright Global Life Sciences Conference on March 10, with an on-demand presentation available on March 9 at 7:00 a.m. ET. The second is the Oppenheimer 31st Annual Healthcare Conference from March 16-18, where Gamida Cell will present on March 18 at 8:40 a.m. ET. Webcasts of the presentations will be accessible on Gamida Cell’s website for at least 14 days post-event.

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Gamida Cell Ltd. (Nasdaq: GMDA) will host a conference call on March 9, 2021, at 8:30 a.m. ET to discuss its full year 2020 financial results and company updates. Interested parties can access the live audio webcast through the 'Investors & Media' section of Gamida Cell's website. Participants can join the call by dialing 866-930-5560 (domestic) or 409-216-0605 (international), referencing conference ID 1996281. A replay will be available approximately two hours post-event for 30 days.

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Gamida Cell Ltd. (Nasdaq: GMDA) announced the presentation of results from its Phase 3 clinical trial of omidubicel at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2021). The presentation is scheduled for March 15, 2021, at 3:24 p.m. CET. Omidubicel, an advanced cell therapy for blood cancers, has shown significant results in prior studies and plans to submit a Biologics License Application (BLA) to the FDA in H2 2021. The company aims to redefine standards of care in hematologic malignancies.

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Gamida Cell Ltd. (Nasdaq: GMDA) has announced the sale of $75 million in 5.875% exchangeable senior notes due in 2026 to funds managed by Highbridge Capital Management. The proceeds, along with previous funding, will support operational liquidity into H2 2022, focusing on manufacturing and regulatory activities for omidubicel and GDA-201. CEO Julian Adams emphasized that this financing strengthens the company's financial position, allowing for advancement in clinical development and regulatory submissions for omidubicel, which has shown promising Phase 3 results.

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Gamida Cell Ltd. (Nasdaq: GMDA) announced Phase 3 clinical study results of omidubicel for high-risk hematologic malignancies, presented at the TCT Meetings. The study showed that omidubicel led to faster hematopoietic recovery, fewer infections, and reduced hospitalization days compared to standard umbilical cord blood transplants. The median time to neutrophil engraftment was 12 days versus 22 days for the comparator (p<0.001). Gamida Cell plans to submit a Biologics License Application to the FDA in H2 2021, potentially establishing omidubicel as a new standard of care.

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Gamida Cell Ltd. (Nasdaq: GMDA) announced the presentation of full Phase 3 trial results for omidubicel at the upcoming TCT Meetings, scheduled from February 8–12, 2021. This randomized, international study assessed omidubicel's efficacy and safety compared to standard umbilical cord blood transplants in patients with blood cancers undergoing transplant. Previous data indicated successful primary and secondary endpoints, notably improved engraftment timelines. The presentation is led by Dr. Mitchell E. Horwitz on February 9, 2021, and the company plans to file a biologics license application with the FDA later in 2021.

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Gamida Cell Ltd. (Nasdaq: GMDA), a leading cell therapy company, will participate in two investor conferences in January 2021. The H.C. Wainwright Bioconnect 2021 Conference is scheduled for January 11-14, with its presentation available for on-demand viewing starting January 11 at 6:00 a.m. ET. Additionally, at the 15th Annual Stern IR Corporate Access Event, the company will provide its presentation on January 11 at 7:00 a.m. ET, alongside one-on-one meetings from January 11-14. Webcasts will be accessible on Gamida Cell's website for 14 days post-event.

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Gamida Cell Ltd. (Nasdaq: GMDA) has completed its public offering, closing on December 21, 2020. The offering included 9,343,750 ordinary shares at $8.00 per share, yielding gross proceeds of approximately $74.75 million before expenses. This total reflects the full exercise of underwriters' options, allowing for an additional 1,218,750 shares. Piper Sandler & Co., Evercore Group, and JMP Securities managed the offering. The securities were registered under Form F-3, declared effective on November 27, 2019.

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Gamida Cell Ltd. (Nasdaq: GMDA) has been selected for inclusion in the NASDAQ Biotechnology Index, effective December 21, 2020. This index tracks the performance of biotechnology and pharmaceutical securities listed on NASDAQ, which must meet minimum market value and share volume criteria. Inclusion in the index may enhance GMDA's visibility and attract more investment as it forms the basis for various Exchange-Traded Funds (ETFs). Gamida Cell focuses on advanced cell therapies aimed at treating blood cancers and serious hematologic diseases.

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Gamida Cell Ltd. (Nasdaq: GMDA) announced a public offering of 8,125,000 ordinary shares priced at $8.00 each, raising $65.0 million in gross proceeds. The offering includes an option for underwriters to purchase an additional 1,218,750 shares. Proceeds will fund the commercial launch of omidubicel, continue clinical development of candidates like GDA-201, and expand manufacturing capabilities. The closing is expected on or about December 21, 2020, pending customary conditions.

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FAQ

What is the market cap of Gamida Cell Ltd. (GMDA)?

The market cap of Gamida Cell Ltd. (GMDA) is approximately 4.3M.

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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