Capricor Therapeutics (CAPR) Tuesday said the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for deramiocel for the treatment of patients with Duchenne muscular dystrophy cardiomyopathy. Following the news, the company's shares were more than 18 percent up in pre-market.
Duchenne muscular dystrophy (DMD) cardiomyopathy refers to a heart muscle disease that develops in people with DMD.
Additionally, FDA granted the BLA priority review with Prescription Drug User Fee Act (PDUFA) date, or a decision expected from the regulator of August 31, 2025.
The BLA submission is supported by results from Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials.
Capricor shares had closed at $13.67, down 11.12 percent on Monday. It has traded in the range of $3.52 - $23.40 in the last 1 year.
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