FDA AdComm Plans to Review Investigational Cell Therapy Deramiocel for DMD Cardiomyopathy

FDA set to decide in August on deramiocel for DMD cardiomyopathy

The U.S. Food and Drug Administration (FDA) is on track to make a decision about deramiocel, an experimental cell therapy designed to treat heart disease in Duchenne muscular dystrophy (DMD), by the end of August. The FDA agreed this year to review an application to approve deramiocel for DMD cardiomyopathy, or disease of the heart muscle. The agency granted the application priority review, shortening the review time to six months down from the …

FDA AdComm Plans to Review Investigational Cell Therapy Deramiocel for DMD Cardiomyopathy

Capricor Therapeutics reported that it remains on track for PDUFA target action date of August 31, 2025 and noted that advisory committee meeting is to be held in advance.