{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-25-009186","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2025-07-11T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.419208+00:00","generated_at":"2026-05-18T06:52:13.179214+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Capricor receives FDA Complete Response Letter for Deramiocel BLA; plans Q3 2025 resubmission with HOPE-3 data","bullets":["FDA issued CRL stating BLA lacks substantial evidence of effectiveness; additional clinical data needed.","Capricor plans to resubmit BLA in Q3 2025 with data from ongoing Phase 3 HOPE-3 trial (104 patients, topline Q3 2025).","FDA confirmed review clock restarts upon resubmission; Type A meeting offered to discuss path forward.","CRL referenced outstanding CMC items, but Capricor believes most were addressed; not reviewed due to CRL timing.","Prior to CRL, BLA had Priority Review, successful pre-licensure inspection, and mid-cycle review completion."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-009186","json":"https://secwatch.observer/filing/0001558370-25-009186.json","markdown":"https://secwatch.observer/filing/0001558370-25-009186.md","text":"https://secwatch.observer/filing/0001558370-25-009186.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000155837025009186/0001558370-25-009186-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000155837025009186/capr-20250711x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T06:52:13.179214+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"}