Capricor Therapeutics Shares Plunge 40% on Release of FDA Briefing Documents

CAPR Capricor Therapeutics Inc

$5.93 -3.26%

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REPL -4.42% BMY -2.41%

1. 1Capricor Therapeutics (CAPR) shares plunged 40% on Monday.
2. 2The decline followed the FDA's release of briefing documents related to the BLA resubmission for deramiocel, a treatment for Duchenne muscular dystrophy cardiomyopathy, ahead of the July 29 meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee.
3. 3The FDA reiterated that at least two adequate and well-controlled clinical trials independently demonstrating convincingly positive efficacy results are required, having previously issued a Complete Response Letter citing insufficient evidence.

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