CAPRICOR THERAPEUTICS, INC. 8K

The FDA extended Capricor Therapeutics’ PDUFA target action date for Deramiocel’s BLA to November 22, 2026 following acceptance of a major amendment with additional Phase 3 HOPE‑3 data supporting a refined indication for Duchenne muscular dystrophy.

Capricor Therapeutics announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for the Biologics License Application (BLA) for Deramiocel, its investigational cell therapy for Duchenne muscular dystrophy, from August 22, 2026 to November 22, 2026, after the company submitted a major BLA amendment including 24‑month open‑label extension data from the Phase 3 HOPE‑3 trial and additional robustness analyses to support a refined proposed indication focused on upper limb function, which the FDA’s Center for Biologics Evaluation and Research accepted for review due to the significant unmet medical need in DMD.

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1133869

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8K

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sec

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0001104659-26-100071

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7