{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-26-095394","form_type":"8-K","ticker":"CVKD","cik":"0001937993","company_name":"Cadrenal Therapeutics, Inc.","filed_at":"2026-08-31T12:29:23+00:00","discovered_at":"2026-08-31T12:30:15.638978+00:00","generated_at":"2026-08-31T12:30:40.792968+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Cadrenal gets FDA alignment on Phase 3 endpoint for CAD-1005 in HIT","bullets":["FDA Type D meeting July 28, 2026; agreed on primary endpoint definition for worsening HIT through Day 14 or discharge.","Primary endpoint: proportion of SRA+ participants with adjudicated new or worsening composite thromboembolic events through Day 14 or hospital discharge.","FDA agreed to placebo control with standard anticoagulation for both CAD-1005 and placebo arms.","HIT affects ~50,000 patients annually in U.S.; CAD-1005 projected $2B peak annual revenue.","Phase 3 will assess bleeding as major safety endpoint using ISTH criteria."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-095394","json":"https://secwatch.observer/filing/0001213900-26-095394.json","markdown":"https://secwatch.observer/filing/0001213900-26-095394.md","text":"https://secwatch.observer/filing/0001213900-26-095394.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1937993/000121390026095394/0001213900-26-095394-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1937993/000121390026095394/ea0303997-8k_cadrenal.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-31T12:30:40.792968+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"}