Capricor says FDA extends Deramiocel DMD BLA decision date to Nov. 22, 2026 after HOPE-3 data filing

Capricor disclosed additional Phase 3 HOPE-3 follow-up data supporting deramiocel in Duchenne muscular dystrophy; results were already generated.

The new evidence reinforced a benefit in preserving upper limb function, aligning with the trial’s main outcome without detailing performance metrics.

FDA accepted the submission as a major BLA amendment, extending the PDUFA target action date to Nov. 22, 2026.

The extended review keeps regulatory timing as the key near-term catalyst for deramiocel’s potential U.S. market entry.