{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-078327","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2026-06-26T21:15:16+00:00","discovered_at":"2026-06-26T21:16:00.244367+00:00","generated_at":"2026-06-26T21:16:13.660571+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA Advisory Committee set for July 29 to review Capricor's Deramiocel BLA; PDUFA date Aug 22","bullets":["FDA CTGTAC Advisory Committee meeting scheduled for July 29, 2026, to discuss Capricor's Deramiocel BLA for Duchenne muscular dystrophy.","PDUFA target action date remains August 22, 2026; BLA on track.","BLA supported by Phase 2 HOPE-2, HOPE-2 OLE, and Phase 3 HOPE-3 trials showing statistical significance on primary and secondary endpoints.","CEO Linda Marbán expressed confidence in the totality of evidence and commitment to urgent needs of DMD community."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-078327","json":"https://secwatch.observer/filing/0001104659-26-078327.json","markdown":"https://secwatch.observer/filing/0001104659-26-078327.md","text":"https://secwatch.observer/filing/0001104659-26-078327.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926078327/0001104659-26-078327-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926078327/capr-20260626x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-26T21:16:13.660571+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"}