{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-087891","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2026-07-29T14:05:21+00:00","discovered_at":"2026-07-29T14:06:00.356507+00:00","generated_at":"2026-07-29T14:06:35.067695+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Capricor's HOPE-3 Deramiocel data published in The Lancet; LVEF p-value revised to 0.09; FDA BIMO inspection cited","bullets":["HOPE-3 Phase 3 results published in The Lancet; primary endpoint met: 54% slowing of upper limb decline (PUL 2.0, p=0.03).","LVEF secondary endpoint p-value revised to 0.09 (1.8 ppt difference) from previously reported 0.04 (2.4 ppt) under updated statistical model.","FDA BIMO inspection (July 6-20) resulted in Form 483 observation on SOPs, documentation, vendor oversight; company says data integrity unaffected.","Deramiocel BLA under FDA review with PDUFA target action date of August 22, 2026.","Pre-specified cardiomyopathy subgroup showed nominally significant LVEF benefit (p=0.02, 2.8 ppt difference)."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-087891","json":"https://secwatch.observer/filing/0001104659-26-087891.json","markdown":"https://secwatch.observer/filing/0001104659-26-087891.md","text":"https://secwatch.observer/filing/0001104659-26-087891.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926087891/0001104659-26-087891-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926087891/capr-20260729x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-29T14:06:35.067695+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"}