FDA extends Capricor's Deramiocel PDUFA target date to Nov 22, 2026

CAPRICOR THERAPEUTICS, INC.

FDA extended PDUFA target date for Deramiocel BLA from Aug 22, 2026 to Nov 22, 2026.
Amendment includes 24-month open-label extension data from pivotal Phase 3 HOPE-3 study.
Capricor requests refined indication focused on upper limb function, HOPE-3's primary endpoint.
HOPE-3 met primary endpoint with statistically significant benefit in upper limb function.
FDA accepted amendment citing significant unmet medical need in Duchenne muscular dystrophy.

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