Capricor Therapeutics (CAPR) surged 383.18% intraday on Wednesday after announcing positive topline results from its pivotal Phase 3 HOPE-3 trial for Deramiocel, its cell therapy targeting Duchenne muscular dystrophy (DMD).

The study met both its primary endpoint (54% slowing of skeletal muscle disease progression) and key secondary cardiac endpoint (91% treatment effect on heart function), with statistically significant results (p=0.03 and p=0.04 respectively). The therapy maintained a favorable safety profile, consistent with prior clinical data.

These results address clinical issues raised in the FDA's Complete Response Letter earlier this year, positioning Deramiocel for potential regulatory approval. Capricor plans to submit its response to the FDA, with analysts noting the data could support a near-term approval for this rare disease treatment.