FDA Lifts CRL for Capricor's Deramiocel, Sets August 2026 PDUFA Date for DMD Therapy
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Capricor Therapeutics announced that the FDA has lifted the previously issued Complete Response Letter (CRL) for its Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy. The FDA has resumed review of the application, classifying it as a Class 2 resubmission, and set a new Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026. This is a significant positive development for Capricor, as it removes a major regulatory overhang and provides a clear timeline for a potential approval decision for its lead product candidate. The resumption of review after a CRL, with no identified potential review issues at this time, de-risks the regulatory pathway. Potential approval would be transformative for the company, addressing a rare disease with limited treatment options, and could also qualify Capricor for a valuable Priority Review Voucher. Investors will now focus on the August 22, 2026 PDUFA date for the final approval decision.
At the time of this announcement, CAPR was trading at $31.60 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.7B. The 52-week trading range was $4.30 to $40.37. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.