secwatch.observer — SEC 8-K summary
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Issuer:     CAPRICOR THERAPEUTICS, INC. (CAPR)
CIK:        0001133869
Form:       8-K
Filed at:   2026-08-24T13:25:30+00:00
Accession:  0001104659-26-100071
Event type: regulatory
Sentiment:  neutral
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA extends Capricor's Deramiocel PDUFA target date to Nov 22, 2026
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- FDA extended PDUFA target date for Deramiocel BLA from Aug 22, 2026 to Nov 22, 2026.
- Amendment includes 24-month open-label extension data from pivotal Phase 3 HOPE-3 study.
- Capricor requests refined indication focused on upper limb function, HOPE-3's primary endpoint.
- HOPE-3 met primary endpoint with statistically significant benefit in upper limb function.
- FDA accepted amendment citing significant unmet medical need in Duchenne muscular dystrophy.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/0001104659-26-100071-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-100071

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