Capricor Therapeutics said the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee is scheduled to meet on July 29, 2026, to review the company’s biologics license application for deramiocel in Duchenne muscular dystrophy.
The application remains on track for the FDA’s PDUFA target action date of Aug. 22, 2026.
Capricor said the filing is supported by Phase 2 HOPE-2 data, long-term follow-up from HOPE-2-OLE, and Phase 3 HOPE-3 results. In HOPE-3, deramiocel met its primary endpoint, pulmonary function measured by PUL v2.0, along with the key secondary cardiac endpoint, left ventricular ejection fraction, and all other type I error-controlled secondary endpoints.
The company did not announce financial results in the release. It said deramiocel has been studied in more than 250 peer-reviewed publications and administered to more than 250 human subjects across multiple trials.
Capricor also noted that Duchenne muscular dystrophy affects about 15,000 people in the U.S. and that heart failure is the leading cause of death in the disease. As a result of these announcements, the company's shares have moved -13.03% on the market, and are now trading at a price of $26.44. For more information, read the company's full 8-K submission here.
