GMDA - Gamida stock rises 13% as FDA grants priority review to stem cell therapy omidubicel

• The U.S. Food and Drug Administration (FDA) granted priority review to Gamida Cell's ( NASDAQ: GMDA ) application seeking approval of stem cell therapy omidubicel to treat patients with blood cancers in need of an allogenic hematopoietic stem cell transplant.
• The FDA accepted the company's Biologics License Application (BLA) and is expected to make a decision by Jan. 30, 2023. Under priority review, the FDA's goal is to take action within six months, compared to 10 months under standard review.
• Gamida said the FDA is not planning to hold an Advisory Committee meeting as part of the BLA review.
• The company noted that the BLA was backed by data from a phase 3 trial.
• Upon FDA approval, omidubicel will be manufactured at the Gamida's manufacturing facility in Israel, the company added.
• GMDA +12.57% to 1.88 premarket Aug. 1

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