The FDA lifted its Complete Response Letter for Capricor Therapeutics ($CAPR) and resumed the review of their application for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy. They originally received the letter back in July 2025. After Capricor submitted new Phase 3 data, the FDA assigned a new PDUFA target action date of August 22, 2026. The company said the FDA hasn't flagged any potential review issues at this point. They also expect to be eligible for a Priority Review Voucher if the therapy gets approved.