Capricor Shares Rise as FDA Sets August 2026 Decision Date for Deramiocel in Duchenne Muscular Dystrophy After Prior Rejection

The FDA lifted a Complete Response Letter issued in July 2025 and resumed review of Capricor Therapeutics' Biologics License Application (BLA) for deramiocel, an investigational cell therapy for DMD cardiomyopathy, setting a PDUFA target action date of August 22, 2026.4 5

This follows positive results from the pivotal Phase 3 HOPE-3 trial, which met its primary endpoint and secondary endpoints, supporting the resubmission.4

Capricor shares surged significantly, with reports of 18.5% gain over the past week, 384% over six months, and trading at $34.24 with $1.58 billion market cap amid the news.6

No potential review issues identified by FDA at this time; company eligible for Priority Review Voucher if approved by September 30, 2026.4 1

Deramiocel previously received FDA acceptance and Priority Review in March 2025 with an August 31, 2025 PDUFA date, but was rejected requiring more data.1 3