---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-117947"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2025-12-03T23:59:59+00:00"
generated_at: "2026-05-16T15:01:46.014955+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Capricor Therapeutics Announces Positive Phase 3 HOPE-3 Results for Deramiocel in Duchenne Muscular Dystrophy

## Summary
- Primary endpoint PUL v2.0 met with 54% slowing of progression (p=0.029) in 105 evaluable patients.
- Key secondary cardiac endpoint LVEF showed 91% slowing of decline (p=0.041) in 83 evaluable patients.
- Study enrolled 106 participants (average age 15) across 20 U.S. sites; over 75% had diagnosed cardiomyopathy.
- Deramiocel maintained a favorable safety and tolerability profile consistent with prior clinical experience.
- Company plans to submit response to Complete Response Letter incorporating HOPE-3 data following prior FDA alignment.

## SEC filing metadata
- accession: 0001104659-25-117947
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2025-12-03T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000110465925117947/0001104659-25-117947-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000110465925117947/capr-20251203x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-117947
- JSON: https://secwatch.observer/filing/0001104659-25-117947.json
- Plain text: https://secwatch.observer/filing/0001104659-25-117947.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.