secwatch.observer — SEC 8-K summary
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Issuer:     CAPRICOR THERAPEUTICS, INC. (CAPR)
CIK:        0001133869
Form:       8-K
Filed at:   2026-08-13T20:07:30+00:00
Accession:  0001104659-26-095908
Event type: earnings
Sentiment:  negative
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Capricor Q2 net loss $40.7M; FDA panel votes 9-3 against Deramiocel cardiomyopathy
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- Net loss $40.7M ($0.70/share) vs $25.9M loss in Q2 2025; no revenue; cash $237.9M at June 30.
- FDA advisory committee voted 9-3 against substantial evidence for cardiomyopathy; vote non-binding, BLA still under review.
- HOPE-3 Phase 3 published in Lancet; primary endpoint upper limb function met (p=0.029); LVEF model revised to p=0.09.
- FDA BIMO inspection issued Form 483 with one observation; responses submitted; awaiting feedback.
- Withdrew preliminary injunction vs NS Pharma; arbitration expected this fall; seeks rescission of distribution agreement.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1133869/000110465926095908/0001104659-26-095908-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1133869/000110465926095908/capr-20260813x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-095908

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