{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-100071","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2026-08-24T13:25:30+00:00","discovered_at":"2026-08-24T13:26:00.350210+00:00","generated_at":"2026-08-24T13:26:14.195443+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA extends Capricor's Deramiocel PDUFA target date to Nov 22, 2026","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-100071","json":"https://secwatch.observer/filing/0001104659-26-100071.json","markdown":"https://secwatch.observer/filing/0001104659-26-100071.md","text":"https://secwatch.observer/filing/0001104659-26-100071.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/0001104659-26-100071-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-24T13:26:14.195443+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}