Capricor Therapeutics announced plans to amend its Duchenne muscular dystrophy (DMD) therapy filing after an FDA advisory committee setback. The company said it will ask the FDA to review additional data and analyses, targeting a narrower indication in hopes of improving the probability of approval. The response follows investor attention after the FDA was described as “willing to review” updated information. Capricor’s therapy, deramiocel, has been supported by an open-label extension route for DMD cardiomyopathy, which previously helped drive renewed interest around the program. The next regulatory step for Capricor centers on how additional datasets are packaged—particularly around patient subset differentiation, safety, and efficacy signals—to address the FDA committee’s concerns and potentially refine labeling scope.