GMDA - Gamida Cell sinks after delayed plan for omidubicel filing

Gamida Cell (GMDA) fell 19% in premarket trading after saying FDA feedback means that the company won’t begin a rolling marketing submission by year’s end.The company now intends to submit a full marketing application for omidubicel in 2H of 2021, with potential U.S. commercial launch as soon as mid-2022.Regulators recommended the company generate additional manufacturing- related data prior to requesting a pre-BLA meetingThough during its “Type B” meeting with the FDA, the agency provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints.Omidubicel is first bone marrow transplant cell therapy product to receive FDA Breakthrough Therapy Designation.GMDA shares had climbed 131% this year through last week.

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Gamida Cell sinks after delayed plan for omidubicel filing