{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-25-000010","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2025-01-02T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.013383+00:00","generated_at":"2026-05-28T17:36:22.125370+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Capricor submits BLA for deramiocel to FDA for DMD cardiomyopathy; receives $10M milestone","bullets":["BLA for deramiocel (cell therapy) submitted to FDA for DMD cardiomyopathy on Jan 2, 2025.","Submission triggers $10M milestone payment from partner Nippon Shinyaku to Capricor.","If approved, deramiocel would be first approved therapy for DMD cardiomyopathy.","Priority review requested; if granted, review timeline reduced to ~6 months from acceptance.","Deramiocel holds Orphan Drug, RMAT (US), ATMP (EU) designations; potential PRV if approved."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-000010","json":"https://secwatch.observer/filing/0001558370-25-000010.json","markdown":"https://secwatch.observer/filing/0001558370-25-000010.md","text":"https://secwatch.observer/filing/0001558370-25-000010.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000155837025000010/0001558370-25-000010-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000155837025000010/capr-20250102x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-28T17:36:22.125370+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"}