Shares of Gamida Cell (NASDAQ: GMDA) plunged in morning trading on Tuesday after the company developing NAM-enabled cell therapies for cancer patients gave a regulatory update. The company stated that the U.S. FDA extended the review period for its application for its advanced cell therapy candidate, lead candidate omidubicel.
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GMDA stated that as a part of the review of its Biologics License Application (BLA) for omidubicel, the U.S. FDA had extended the Prescription Drug User Fee Act (PDUFA) date from January 30 next year to May 1, 2023. The company added that the FDA had “also rescheduled Gamida Cell’s late-cycle meeting to the first quarter of 2023.”
Shares of GMDA have already lost more than 40% in value in the past year. But Wall Street analysts are bullish about GMDA stock with a Strong Buy consensus rating based on five unanimous Buys.
