FDA Extends Deramiocel Review to November 22 After Major Amendment

Company: Capricor Therapeutics · Asset: Deramiocel · Indication: Duchenne Muscular Dystrophy · Event Type: PDUFA Date Extension · Date: August 24, 2026 Summary FDA extended the PDUFA target action date for Capricor’s deramiocel BLA from August 22 to November 22, 2026, after the company submitted…

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