Capricor reports 24-month data for Duchenne therapy deramiocel

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 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.

Capricor Therapeutics (CAPR) presented positive 24-month data from its HOPE-3 open-label extension study for Deramiocel, showing a 76% reduction in upper limb decline for DMD patients who switched from placebo to treatment. Both treatment groups showed slower decline than natural history predicts. The data is included in Deramiocel's BLA major amendment, with a PDUFA target action date of November 22, 2026. A webinar is scheduled for October 7, 2026, to discuss the results.