Gamida Cell to Present Corporate Highlights at the Oppenheimer 33rd Annual Healthcare Conference
Gamida Cell Ltd. (NASDAQ: GMDA) announced that CEO Abbey Jenkins will present at the Oppenheimer 33rd Annual Healthcare Conference on March 14, 2023, at 9:20 a.m. ET. The presentation will cover corporate highlights and updates on the lead product candidate, omidubicel, which has a PDUFA action date set for May 1, 2023, from the FDA. Omidubicel is an advanced cell therapy for allogeneic stem cell transplants, designed to improve outcomes for blood cancer patients. The candidate has shown a significant reduction in engraftment times and fewer complications compared to standard treatments. The webcast will be available on Gamida Cell's website for 14 days.
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The webcast will be available on the “Investors & Media” section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.
About Omidubicel
Omidubicel is an advanced cell therapy candidate for allogeneic hematopoietic stem cell (bone marrow) transplant that, if approved, has the potential to expand access and improve outcomes for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT02730299) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU. Omidubicel has a PDUFA target action date of
Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.
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Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of the FDA’s review of the BLA for omidubicel, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including omidubicel). Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on our business; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Quarterly Report on Form 10-Q, filed with the
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FAQ
What is the purpose of Gamida Cell's presentation at the Oppenheimer Conference on March 14, 2023?
What is the PDUFA action date for omidubicel and what does it signify?
How does omidubicel improve the outcomes for patients undergoing stem cell transplants?
Where can investors access the webcast of Gamida Cell's presentation?