Capricor Therapeutics (CAPR) said Tuesday it has received the US Food and Drug Administration's acceptance for review of its biologics license application for full approval of deramiocel to treat Duchenne muscular dystrophy cardiomyopathy.
The regulator's decision was based on the company's current cardiac data from its phase 2 HOPE-2 and HOPE-2 open label extension studies, Capricor added.
The regulator set Aug. 31 as the Prescription Drug User Fee Act target action date without any potential review issues at the moment, the company said.
Capricor's stock rose nearly 12% in recent Tuesday premarket activity.
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