Capricor reports positive HOPE-3 trial results for Duchenne therapy

Capricor Therapeutics (NASDAQ: CAPR) announced additional data from its Phase 3 HOPE-3 clinical trial of Deramiocel for Duchenne muscular dystrophy at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference in Orlando, Florida.

The trial results showed reduced progression of myocardial fibrosis measured by late gadolinium enhancement on cardiac MRI (p=0.022). In patients with baseline cardiomyopathy, Deramiocel demonstrated a 3.3 percentage-point improvement in left ventricular ejection fraction versus placebo (p=0.017).

A Global Statistical Test composite endpoint, which included Performance of Upper Limb, left ventricular ejection fraction, and Patient Global Impression of Severity, showed statistically significant overall treatment benefit favoring Deramiocel (p=0.017).

The Duchenne Video Assessment measuring hand-to-mouth activity showed approximately 83% slowing of disease progression compared with placebo (p=0.018). These findings aligned with results from the mid-level Performance of Upper Limb v2.0 assessment (p=0.008).

Deramiocel consists of allogeneic cardiosphere-derived cells and has received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency. The company's Biologics License Application is currently under FDA review with a PDUFA target action date of August 22, 2026.

The information is based on a company press release statement. Capricor has submitted the full HOPE-3 study results for publication in a peer-reviewed scientific journal.

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