{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-016149","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2023-09-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.215976+00:00","generated_at":"2026-06-10T06:47:36.395198+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Capricor announces positive FDA Type-B meeting confirming Phase 3 path to BLA for CAP-1002 in DMD","bullets":["FDA aligned on HOPE-3 trial design; key endpoints unchanged; BLA submission targeted for 2025.","HOPE-3 enrollment ~90% complete (52 of ~58 patients dosed); interim analysis expected Q4 2023.","Topline data for HOPE-3 expected Q4 2024; BLA supported by product from Los Angeles site.","San Diego site work continues for potential commercial demand; CAP-1002 holds Orphan Drug and RMAT designations.","Company eligible for Priority Review Voucher if CAP-1002 receives FDA approval for DMD."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-016149","json":"https://secwatch.observer/filing/0001558370-23-016149.json","markdown":"https://secwatch.observer/filing/0001558370-23-016149.md","text":"https://secwatch.observer/filing/0001558370-23-016149.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000155837023016149/0001558370-23-016149-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000155837023016149/capr-20230929x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T06:47:36.395198+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"}