{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-24-012983","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2024-09-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:12.258855+00:00","generated_at":"2026-05-31T01:59:47.756551+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Capricor Therapeutics to file BLA for deramiocel in DMD cardiomyopathy; rolling submission in Oct 2024","bullets":["Plans to file BLA for deramiocel to treat DMD cardiomyopathy based on existing cardiac and natural history data; rolling submission begins Oct 2024 with full submission by year-end 2024.","BLA supported by Phase 2 HOPE-2 and HOPE-2 OLE data vs natural history from Vanderbilt and Cincinnati Children's.","Will combine Cohorts A and B of Phase 3 HOPE-3 as a post-approval study; no unblinding of Cohort A as previously planned for Q4 2024.","Deramiocel has FDA Orphan Drug, RMAT, and Rare Pediatric Disease designations (PRV eligible upon approval).","No approved therapies for DMD cardiomyopathy; deramiocel targets leading cause of death in Duchenne."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-24-012983","json":"https://secwatch.observer/filing/0001558370-24-012983.json","markdown":"https://secwatch.observer/filing/0001558370-24-012983.md","text":"https://secwatch.observer/filing/0001558370-24-012983.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000155837024012983/0001558370-24-012983-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000155837024012983/capr-20240924x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T01:59:47.756551+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"}