On Tuesday, the FDA accepted for evaluate Capricor Therapeutics Inc’s CAPR Biologics License Software for deramiocel, an investigational cell remedy, as a therapy for sufferers identified with Duchenne muscular dystrophy (DMD) cardiomyopathy.
DMD cardiomyopathy is a coronary heart situation characterised by cardiac fibrosis, arrhythmias, and coronary heart failure.
Moreover, the FDA granted the BLA Precedence Evaluation with a Prescription Drug Consumer Charge Act (PDUFA) goal motion date of August 31, 2025.
The FDA has not recognized any potential evaluate points.
Additionally Learn: Capricor Therapeutics Says Duchenne Muscular Dystrophy Candidate Reveals Sustained Cardiac, Skeletal Advantages After 3 Years
The BLA submission is supported by Capricor’s current cardiac information from its Part 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials in comparison with pure historical past information.
The FDA additionally knowledgeable the corporate that they haven’t but determined whether or not an Advisory Committee assembly is required concerning this software.
Deramiocel for DMD has obtained Orphan Drug Designation from the FDA and European Medicines Company.
As well as, if Capricor have been to obtain FDA advertising approval for deramiocel concerning the therapy of DMD by September 30, 2026, Capricor can be eligible to obtain a Precedence Evaluation Voucher primarily based on its earlier receipt of a uncommon pediatric illness designation.
Value Motion: CAPR inventory is up 6.33% at $14.54 on the final test Tuesday.
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