$CAPR (CAPRICOR THERAPEUTICS) — 8-K: FDA extends Deramiocel PDUFA date to November 22, 2026 after major amendment

The FDA extended the PDUFA target action date for Capricor’s Deramiocel BLA in Duchenne muscular dystrophy from August 22, 2026 to November 22, 2026. The extension follows Capricor’s submission of 24-month open-label extension data from the Phase 3 HOPE-3 study and additional robustness analyses. The FDA classified the submission as a major amendment and accepted it for review, citing significant unmet medical need in DMD.

The FDA extended the PDUFA target action date for Capricor’s Deramiocel BLA in Duchenne muscular dystrophy from August 22, 2026 to November 22, 2026. The extension follows Capricor’s submission of 24-month open-label extension data from the Phase 3 HOPE-3 study and additional robustness analyses. The FDA classified the submission as a major amendment and accepted it for review, citing significant unmet medical need in DMD.