GMDA - Gamida Cell completes rolling submission to the FDA for omidubicel

Gamida Cell (NASDAQ:GMDA +6.5%) said on Thursday it had completed the rolling submission of a Biologics License Application for omidubicel, a treatment for patients with blood cancers in need of stem cell transplant. The FDA has 60 days to determine whether the BLA for omidubicel is acceptable for filing, the company said. A late-stage trial of omidubicel showed statistical significant results.

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Gamida Cell completes rolling submission to the FDA for omidubicel