FDA pushes back PDUFA date for Capricor's Duchenne therapy to review new data

The U.S. Food and Drug Administration announced it has extended the PDUFA target date for Capricor Therapeutics' investigational Duchenne muscular dystrophy treatment.

The agency said the extension is to allow review of additional data that the company submitted, focusing on a narrower patient population.

Capricor acknowledged the delay and said it will continue to work with regulators while awaiting the outcome.