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Capricor Therapeutics down after responding to FDA's 'complete response letter'

ReutersSep 9, 2025 2:18 PM

** Therapy developer Capricor Therapeutics' shares CAPR.O down 1.2% at $6.28

** CAPR says it was not notified of U.S. FDA's decision to make the "complete response letter" public for its cell therapy for a type of muscle disorder

** Company says letter originally received in July 2025 for its therapy, Deramiocel

** However, the FDA did not release the comprehensive preliminary response that Capricor submitted shortly after receipt of the CRL, company says, which has been made available on the investor section of its website

** "The Capricor team was faced with many questions from the public that could not be addressed due to the lack of communication from the FDA," says CEO Linda Marbán in its response letter

** Company expects data from late-stage study in Q4 2025

** Including session's moves, stock down 54.4% YTD

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