Capricor issued a press release on May 5, 2025, announcing that after "the completion of a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for the Company's Biologics License Application (BLA) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy", the FDA had "confirmed its intent to hold an advisory committee meeting" in connection with the BLA.
Following this news, Capricor's stock price fell over 29% on May 6, 2025.
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