Capricor Therapeutics IncFDA advisory panel declined to endorse Deramiocel, and STAT report raises concerns about potential rejection.

Capricor Therapeutics shares declined on Thursday after a STAT News report renewed concerns about a potential U.S. rejection of its lead candidate, Deramiocel. An FDA advisory panel declined to endorse the cell therapy last month, and the drug is under regulatory review for cardiomyopathy in Duchenne muscular dystrophy with a target action date of August 22. STAT senior writer Adam Feuerstein called the company's plan to submit open-label extension data from its Phase 3 HOPE-3 trial a stall tactic, adding that it is not clear why the company publicly maintains confidence in the drug. Capricor did not immediately respond to a request for comment.
Capricor Therapeutics IncFDA advisory panel declined to endorse Deramiocel, and STAT report raises concerns about potential rejection.