Capricor Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

March 13, 2026 - 04:55

Capricor Therapeutics has announced its financial results for the fourth quarter and full year 2025, alongside significant progress in its lead clinical program. The company's Biologics License Application (BLA) for deramiocel (CAP-1002) as a treatment for Duchenne muscular dystrophy (DMD) is now under formal review by the U.S. Food and Drug Administration. The agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026, marking a critical regulatory milestone.

This filing is supported by robust data from the pivotal HOPE-3 Phase 3 trial, which successfully achieved its primary endpoint using the Performance of the Upper Limb version 2.0 (PUL v2.0) scale and a key secondary cardiac endpoint measuring left ventricular ejection fraction (LVEF). Additional late-breaking data from HOPE-3, presented at the Muscular Dystrophy Association Clinical Conference in 2026, demonstrated further cardiac and functional benefits for patients.

In preparation for a potential commercial launch following regulatory approval, Capricor has confirmed that its Good Manufacturing Practice (GMP) facility in San Diego is fully operational. This in-house capability is designed to ensure supply and control for deramiocel.

Further strengthening its corporate profile, Capricor completed an uplisting to the Nasdaq Global Select Market. The company reported a strong financial position to advance its objectives, with a year-end cash balance of approximately $318 million. These funds are expected to support ongoing operations and the commercial readiness activities leading up to the FDA's decision on deramiocel next year.