NasdaqGS:CAPRBiotechs
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...