{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-24-031371","form_type":"8-K","ticker":"CVKD","cik":"0001937993","company_name":"Cadrenal Therapeutics, Inc.","filed_at":"2024-04-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:21.259234+00:00","generated_at":"2026-06-04T01:10:05.114469+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Cadrenal Therapeutics receives FDA Orphan Drug Designation for tecarfarin in VAD patients","bullets":["FDA granted ODD for tecarfarin to prevent thromboembolism/thrombosis in patients with LVADs, RVADs, biventricular assist devices, and total artificial hearts.","ODD provides up to 7 years of U.S. market exclusivity after approval, tax credits for clinical research, and NDA user fee waiver.","This is tecarfarin's second ODD; first was for prevention of systemic thromboembolism in ESKD/AFib patients.","Warfarin achieves target anticoagulation only 56% of the time in VAD patients; DOACs like Eliquis are not indicated for VADs.","Cadrenal CEO states company is dedicated to advancing tecarfarin through clinical development options as swiftly as possible."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-24-031371","json":"https://secwatch.observer/filing/0001213900-24-031371.json","markdown":"https://secwatch.observer/filing/0001213900-24-031371.md","text":"https://secwatch.observer/filing/0001213900-24-031371.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1937993/000121390024031371/0001213900-24-031371-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1937993/000121390024031371/ea0203558-8k_cadrenal.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T01:10:05.114469+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"}