Gamida Cell Ltd (GMDAQ)

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Gamida Cell Provides Regulatory Update on Omidubicel

https://finance.yahoo.com/news/gamida-cell-provides-regulatory-omidubicel-215200687.html

Recent company submission in response to FDA request extends PDUFA date by three months

BOSTON, November 21, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematological and solid cancers and other serious diseases, today 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.

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. 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," said Abigail "Abbey" Jenkins, Gamida Cell’s President and Chief Executive Officer. "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."