Capricor Therapeutics moved to preserve its Duchenne muscular dystrophy (DMD) regulatory path after an adverse FDA advisory committee outcome, saying it will seek FDA review of additional data and analyses. The company framed the next step as an attempt to narrow its approval approach and strengthen the evidence package. Market reaction followed with a reported stock surge tied to the prospect of an FDA willingness-to-review update, according to coverage of the company’s strategy and CEO comments. The update keeps Capricor’s allogeneic cell therapy deramiocel in focus as an example of how DMD programs are navigating an approval bar shaped by committee feedback and evidence refinements.
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