Capricor Therapeutics (CAPR) shares were down more than 11% in recent trading on Monday after the company said the US Food and Drug Administration plans to hold an advisory committee meeting to review its biologics license application for deramiocel, an investigational cell therapy for treating cardiomyopathy in Duchenne muscular dystrophy patients.

Capricor said no significant deficiencies were identified in the application during a recent mid-cycle review meeting with the FDA. The agency is expected to decide by the Aug. 31 Prescription Drug User Fee Act target action date.

An official date for the advisory committee meeting has not yet been set, according to Capricor.

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