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Capricor Therapeutics said that its cell therapy for Duchenne muscular dystrophy met both a primary and key secondary endpoint in a Phase 3 trial, boosting the company’s odds for approval as it returns to the FDA following the rejection of its therapy in July.
Capricor is one of several rare disease drug developers that have been entangled in FDA drama. Earlier this year, the agency scheduled and then canceled an advisory committee meeting for the treatment, called deramiocel. It then turned down the application, saying deramiocel didn’t show “substantial evidence of effectiveness.”
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