FDA grants Capricor three-month extension to review DMD cell therapy data

The U.S. Food and Drug Administration has given Capricor Therapeutics an additional three months to evaluate its Duchenne muscular dystrophy cell therapy after the agency asked for more information.

An advisory committee previously voted 9‑3 against the therapy’s efficacy on a cardiomyopathy endpoint, prompting Capricor to submit new data and shift its focus to upper‑limb function. The FDA agreed to consider the supplemental data, extending the review deadline to November 22.

Investors remain cautious, with the negative advisory vote lowering the company’s valuation and casting doubt on the likelihood of approval despite the extended timeline.