Why Capricor Therapeutics (CAPR) Is Up 29.3% After FDA Resumes Review of Deramiocel BLA
- Capricor Therapeutics announced that the FDA has lifted its prior Complete Response Letter and resumed review of the Biologics License Application for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy cardiomyopathy, assigning a Class 2 resubmission with a PDUFA target action date of August 22, 2026.
- This renewed review, combined with Deramiocel’s multiple regulatory designations and a commercialization agreement with Nippon Shinyaku for the U.S. and Japan, reshapes how investors may view Capricor’s path toward potential market entry in rare disease cardiomyopathy.
- Against this backdrop, we will examine how the renewed FDA review timeline for Deramiocel influences Capricor Therapeutics’ broader…
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