{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-25-002097","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2025-03-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.013582+00:00","generated_at":"2026-05-25T12:45:59.835889+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA accepts Capricor's BLA for deramiocel for DMD cardiomyopathy with Priority Review, PDUFA Aug 31, 2025","bullets":["FDA accepted BLA for deramiocel (cell therapy) to treat Duchenne muscular dystrophy cardiomyopathy.","Priority Review granted; PDUFA target date August 31, 2025.","FDA has not identified any potential review issues at this time.","If approved, deramiocel would be first approved therapy for DMD cardiomyopathy.","Supports Phase 2 HOPE-2 and OLE trials vs. natural history data from FDA-funded dataset."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-002097","json":"https://secwatch.observer/filing/0001558370-25-002097.json","markdown":"https://secwatch.observer/filing/0001558370-25-002097.md","text":"https://secwatch.observer/filing/0001558370-25-002097.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000155837025002097/0001558370-25-002097-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000155837025002097/capr-20250304x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-25T12:45:59.835889+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"}