secwatch.observer — SEC 8-K summary
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Issuer:     CAPRICOR THERAPEUTICS, INC. (CAPR)
CIK:        0001133869
Form:       8-K
Filed at:   2025-12-03T23:59:59+00:00
Accession:  0001104659-25-117947
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1133869/000110465925117947/0001104659-25-117947-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1133869/000110465925117947/capr-20251203x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-117947

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer