{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-095908","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2026-08-13T20:07:30+00:00","discovered_at":"2026-08-13T20:10:02.663337+00:00","generated_at":"2026-08-13T20:10:34.225392+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Capricor Q2 net loss $40.7M; FDA panel votes 9-3 against Deramiocel cardiomyopathy","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-095908","json":"https://secwatch.observer/filing/0001104659-26-095908.json","markdown":"https://secwatch.observer/filing/0001104659-26-095908.md","text":"https://secwatch.observer/filing/0001104659-26-095908.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926095908/0001104659-26-095908-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926095908/capr-20260813x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-13T20:10:34.225392+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"}