GMDA - Gamida Cell targets 2021 for Omidubicel launch against blood cancers

Giving a pipeline update, Gamida Cell (NASDAQ:GMDA) reaffirms the clinical success of its cell therapy candidate, omidubicel in a Phase 3 study evaluating the safety and efficacy in patients with hematologic malignancies (blood cancers).Under development as an allogeneic hematopoietic stem cell (bone marrow) transplant solution, omidubicel, has met all three of the prespecified secondary endpoints of the study, analyzed in all randomized patients (intent-to-treat).The previously-reported data in May showed the experimental therapy meeting its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient’s recovery from a bone marrow transplant.Targeting a Biologics License Application submission by the end of this year, and publication of the data set in a peer-reviewed setting early next year, Gamida expects to launch the therapy in Q4 2021 subject to FDA approval.Omidubicel, filed for an investigational new drug application under the brand name CordIn®, is also undergoing a Phase

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Gamida Cell targets 2021 for Omidubicel launch against blood cancers