Capricor Therapeutics Presents Positive HOPE-3 Open-Label Extension Data on Upper Limb Function in Duchenne Muscular Dystrophy at 2026 World Muscle Society Congress

Capricor Therapeutics (CAPR) shares rose 5% after presenting additional heart data for Deramiocel ahead of an FDA decision on November 22. The company submitted 24-month clinical data analyses, focusing on preserving upper-limb function. The FDA initially rejected the therapy in July 2025, citing insufficient evidence, and an advisory committee recently voted 9-3 against its effectiveness for cardiomyopathy. CAPR stock is down 72% year-to-date.

Capricor presented two-year data on deramiocel, showing a 1.56-point difference in upper-limb decline for the delayed-start group. Patients treated for two years had a 3.4-point decline in PUL 2.0. Cardiac MRI data showed a 2.8% treatment effect on LVEF. The company plans to explore regulatory pathways outside the U.S. and monitor safety in combination therapies.

Capricor Therapeutics shares fell 10% Monday despite positive deramiocel trial data, as investors doubt FDA approval for the Duchenne muscular dystrophy treatment.

Capricor Therapeutics (CAPR) reported that Deramiocel slowed upper limb decline in DMD patients in a 24-month HOPE-3 study. Patients switching to Deramiocel saw a 76% reduction in decline rate. The FDA has a PDUFA date of November 22, 2026, for Deramiocel's BLA. CAPR stock is currently at $8.19.

Capricor Therapeutics (CAPR) presented 24-month data for deramiocel, a Duchenne muscular dystrophy treatment, at the World Muscle Society Congress. Patients switching from placebo to deramiocel showed a 76% reduction in upper limb decline. The FDA is reviewing the data, with a PDUFA target date of November 22, 2026. The study included 106 patients, with 98 entering the open-label extension.

Capricor Therapeutics reported that Deramiocel slowed upper limb decline by 76% in HOPE-3 OLE data. The company included this data in a BLA amendment, with an FDA target action date of Nov. 22, 2026.