Capricor submits BLA for deramiocel to FDA for DMD cardiomyopathy; receives $10M milestone

CAPRICOR THERAPEUTICS, INC.

BLA for deramiocel (cell therapy) submitted to FDA for DMD cardiomyopathy on Jan 2, 2025.
Submission triggers $10M milestone payment from partner Nippon Shinyaku to Capricor.
If approved, deramiocel would be first approved therapy for DMD cardiomyopathy.
Priority review requested; if granted, review timeline reduced to ~6 months from acceptance.
Deramiocel holds Orphan Drug, RMAT (US), ATMP (EU) designations; potential PRV if approved.

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