- The stock price of Gamida Cell (GMDA) fell by over 20% pre-market today. This is why.
The stock price of Gamida Cell (GMDA) fell by over 20% pre-market today. This is why.
Why: Gamida Cell provided an update on recent interactions with the U.S. Food and Drug Administration (FDA) relating to the company’s Biologics License Application (BLA) for omidubicel, the company’s advanced cell therapy candidate for allogeneic hematopoietic stem cell transplant.
Details: As part of its ongoing BLA review, FDA issued an information request and viewed the data in the response as a major amendment, resulting in an extension of the omidubicel Prescription Drug User Fee Act (PDUFA) date from January 30, 2023, to May 1, 2023. And the agency also rescheduled Gamida Cell’s late-cycle meeting to the first quarter of 2023. The data FDA requested were laboratory results for intermediate time points for patients enrolled in the Phase 3 study. These additional data provided by Gamida Cell to FDA are consistent with prior data submissions.
“We appreciate the FDA’s collaboration as they conduct their review of omidubicel. If approved, omidubicel will be the first and only advanced cell therapy for patients with blood cancer in need of an allogeneic stem cell transplant. We are committed to bringing this potentially transformative therapy forward as quickly as possible.”
— Abigail “Abbey” Jenkins, Gamida Cell’s President and Chief Executive Officer