{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-025657","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2026-03-10T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.602066+00:00","generated_at":"2026-05-15T15:29:47.854558+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA lifts CRL for Deramiocel BLA; new PDUFA date August 22, 2026","bullets":["FDA resumed review of Deramiocel BLA for Duchenne muscular dystrophy cardiomyopathy after lifting CRL.","Submission classified as Class 2 resubmission; PDUFA target action date set for August 22, 2026.","BLA supported by positive HOPE-3 Phase 3 trial meeting primary and all secondary endpoints.","Company expects to be eligible for a Priority Review Voucher upon potential approval.","FDA has not identified any review issues in its response to Capricor at this time."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-025657","json":"https://secwatch.observer/filing/0001104659-26-025657.json","markdown":"https://secwatch.observer/filing/0001104659-26-025657.md","text":"https://secwatch.observer/filing/0001104659-26-025657.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926025657/0001104659-26-025657-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926025657/capr-20260310x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T15:29:47.854558+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"}