FDA extends deadline to decide on Gamida Cell's stem cell transplant therapy by three months

With commercial preparations already underway, Gamida Cell was keenly eyeing the late January deadline for U.S. regulators to decide on the approval application of its stem cell transplant therapy.

But the company will have to contain its restlessness a bit longer, after the FDA extended the review deadline by roughly three months to May 1, 2023. Gamida Cell said new information recently provided to regulators regarding its approval application for omidubicel was considered a “major amendment,” prompting an extension of the application’s deadline, according to a release Tuesday

The FDA requested lab data for intermediate time points for patients enrolled in the phase 3 study, according to Gamida. The data provided were “consistent” with prior data submissions, noted Gamida, which added that its late-cycle meeting with the agency had also been pushed back into the first quarter of 2023. 

The latest move by the FDA likely moves any decision on omidubicel past the one-year mark from when the company began its rolling submission. The back-and-forth with regulators has an even longer history, with the company asked for additional information on its manufacturing facilities before it had even initiated the submission.

Although the January 2022 initiation of its approval application was a milestone in the company’s clinical development, Gamida was forced to cut staff and seek additional financing to afford its commercial plans. The company ultimately cut 10% of its staff and froze new hirings to extend its cash runway to mid-2023. 

Since then, Gamida’s top leadership has changed hands with Abigail Jenkins taking over as CEO in September. Her hiring is a clear nod to the market aspirations of the company, given Jenkins was previously the chief commercial and business officer at Lyndra Therapeutics. Gamida also fortified its financial position last quarter, raising $20 million from a public offering and tacking on a $25 million loan. 

The additional funds have not changed the company’s cash runway, however, meaning Gamida will likely need to raise more money now or cut costs in the future to afford its delayed commercial plans for omidubicel.