FDA Extends Deramiocel Review for Duchenne Muscular Dystrophy

The FDA extended the PDUFA review deadline for Capricor Therapeutics' cell therapy deramiocel for Duchenne muscular dystrophy from August 22 to November 22, 2026, following acceptance of additional phase 3 HOPE-3 trial data as a major amendment. The HOPE-3 trial showed statistically significant slowing of functional decline, but an FDA advisory committee previously voted against approval, citing concerns about trial data changes and surrogate endpoints.

This Wire brief sits within Fusion42's coverage of Biotech, and 5 sources have reported it between 14 Aug 2026 and 24 Aug 2026.