Capricor Therapeutics (CAPR) said Friday the US Food and Drug Administration scheduled an advisory committee meeting for July 29 to review its biologics license application for deramiocel as a treatment for Duchenne muscular dystrophy.
The regulatory submission remains on track for a target action date of Aug. 22, the company said.
The application is supported by phase 2 and extension-trial data, as well as phase 3 results showing the experimental cell therapy met its primary and secondary endpoints, Capricor said.
Shares of the company were up 1% in Monday premarket trading.
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