Capricor Deramiocel Phase 3 Published in The Lancet; FDA Date Set for August 22

CAPR Capricor Therapeutics Inc

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1. 1Capricor Therapeutics' (CAPR) Phase 3 HOPE-3 results for Duchenne muscular dystrophy treatment Deramiocel were published in The Lancet.
2. 2In a trial of 106 patients, the drug reduced upper-limb function decline by 54% versus placebo, meeting the primary endpoint, and also reported cardiac function benefits.
3. 3With the August 22 PDUFA date and advisory committee meeting approaching, the FDA had previously raised concerns over the original primary and secondary endpoints not being met and changes to the analysis plan.

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