{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-24-006020","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2024-04-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:17.410636+00:00","generated_at":"2026-06-03T05:24:08.975820+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Capricor presents CAP-1002 DMD program update: FDA alignment on BLA path; HOPE-3 topline data Q4 2024","bullets":["Enrollment complete in HOPE-3 Phase 3 Cohort A (N=61); topline 12-month data expected Q4 2024.","FDA agreed HOPE-3 Cohort A is sufficient to support BLA; non-clinical comparability shown with two potency assays.","San Diego facility to be used for commercial manufacturing upon potential approval; commercial planning underway with Nippon Shinyaku.","Upcoming Type-C meeting to discuss pre-BLA meeting and rolling BLA submission schedule.","Estimated U.S. DMD annual product revenue opportunity >$1.5B; target addressable patients ~7,500-10,000."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-24-006020","json":"https://secwatch.observer/filing/0001558370-24-006020.json","markdown":"https://secwatch.observer/filing/0001558370-24-006020.md","text":"https://secwatch.observer/filing/0001558370-24-006020.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000155837024006020/0001558370-24-006020-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000155837024006020/capr-20240429x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-03T05:24:08.975820+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"}