The update comes as the therapy’s regulatory application awaits a decision from the U.S. Food and Drug Administration later this year.
Capricor Therapeutics (CAPR) was in focus on Thursday after the biotech firm said new data from its Phase 3 HOPE-3 trial showed that its therapy, Deramiocel, improved key heart function measures in patients with Duchenne muscular dystrophy (DMD).
The findings were presented at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference in Orlando.
CAPR stock fell around 2% higher after the opening bell.
Endpoint Indicates Overall Treatment Benefit
Cardiac MRI showed a significant reduction in fibrosis in patients treated with Deramiocel after 12 months compared with placebo. The MRI results also highlighted that patients with baseline cardiomyopathy saw a 3.3 percentage-point improvement in left ventricular ejection fraction.
Researchers reported a statistically significant overall treatment benefit using a composite measure of patient function and heart health.
FDA Decision Expected In August
Capricor has already submitted a Biologics License Application (BLA) for Deramiocel to the U.S. Food and Drug Administration (US FDA).
The application is currently under review, and the regulator has set Aug. 22, 2026, as the decision date.
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