FDA Advisory Committee set for July 29 to review Capricor's Deramiocel BLA; PDUFA date Aug 22

CAPRICOR THERAPEUTICS, INC.

FDA CTGTAC Advisory Committee meeting scheduled for July 29, 2026, to discuss Capricor's Deramiocel BLA for Duchenne muscular dystrophy.
PDUFA target action date remains August 22, 2026; BLA on track.
BLA supported by Phase 2 HOPE-2, HOPE-2 OLE, and Phase 3 HOPE-3 trials showing statistical significance on primary and secondary endpoints.
CEO Linda Marbán expressed confidence in the totality of evidence and commitment to urgent needs of DMD community.

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