{"filing":{"accession_number":"0001213900-26-095394","cik":"0001937993","ticker":"CVKD","company_name":"Cadrenal Therapeutics, Inc.","form":"8-K","filing_date":"2026-08-31","report_date":"2026-08-31","primary_document":"ea0303997-8k_cadrenal.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1937993/000121390026095394/ea0303997-8k_cadrenal.htm"},"events":[{"id":30514,"run_id":27962,"accession_number":"0001213900-26-095394","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"summary":"Cadrenal announced positive feedback from an FDA Type D meeting on July 28, 2026, regarding alignment on the primary endpoint definition and Statistical Analysis Plan for the Phase 3 registrational study of CAD-1005 for heparin-induced thrombocytopenia. FDA agreement on trial design elements represents a material regulatory milestone that advances the company's path to potential commercialization of this first-in-class therapeutic.","company_name":"Cadrenal Therapeutics, Inc.","ticker":"CVKD","filing_date":"2026-08-31","form":"8-K","submitted_at":null,"items":[{"id":33128,"accession_number":"0001213900-26-095394","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Cadrenal announced positive feedback from an FDA Type D meeting on July 28, 2026, regarding alignment on the primary endpoint definition and protocol for the Phase 3 registrational study of CAD-1005 for heparin-induced thrombocytopenia. This is a material regulatory and clinical development milestone—FDA agreement on primary endpoint design and trial structure directly advances the company's path to potential commercialization of a first-in-class therapeutic with an estimated $2 billion peak annual revenue opportunity. While not a specific named event type, this is clearly an operational/strategic milestone in drug development that would affect a reasonable investor's assessment of the registrant's progress and regulatory pathway.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-31T12:30:42.464430+00:00","company_name":"","ticker":null,"filing_date":""},{"id":33129,"accession_number":"0001213900-26-095394","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Cadrenal announced positive feedback from an FDA Type D meeting on July 28, 2026, regarding alignment on the primary endpoint definition and Statistical Analysis Plan for the Phase 3 registrational study of CAD-1005 for heparin-induced thrombocytopenia (HIT). This represents a material regulatory milestone—FDA agreement on trial design elements is a critical step in the clinical development pathway for a late-stage biopharmaceutical company. The disclosure clarifies the regulatory path forward and strengthens confidence in the Phase 3 protocol, which is operationally significant for a company whose value depends on successful clinical advancement.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-31T12:30:42.464430+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":33128,"accession_number":"0001213900-26-095394","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Cadrenal announced positive feedback from an FDA Type D meeting on July 28, 2026, regarding alignment on the primary endpoint definition and protocol for the Phase 3 registrational study of CAD-1005 for heparin-induced thrombocytopenia. This is a material regulatory and clinical development milestone—FDA agreement on primary endpoint design and trial structure directly advances the company's path to potential commercialization of a first-in-class therapeutic with an estimated $2 billion peak annual revenue opportunity. While not a specific named event type, this is clearly an operational/strategic milestone in drug development that would affect a reasonable investor's assessment of the registrant's progress and regulatory pathway.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-31T12:30:42.464430+00:00","company_name":"Cadrenal Therapeutics, Inc.","ticker":"CVKD","filing_date":"2026-08-31"},{"id":33129,"accession_number":"0001213900-26-095394","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Cadrenal announced positive feedback from an FDA Type D meeting on July 28, 2026, regarding alignment on the primary endpoint definition and Statistical Analysis Plan for the Phase 3 registrational study of CAD-1005 for heparin-induced thrombocytopenia (HIT). This represents a material regulatory milestone—FDA agreement on trial design elements is a critical step in the clinical development pathway for a late-stage biopharmaceutical company. The disclosure clarifies the regulatory path forward and strengthens confidence in the Phase 3 protocol, which is operationally significant for a company whose value depends on successful clinical advancement.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-31T12:30:42.464430+00:00","company_name":"Cadrenal Therapeutics, Inc.","ticker":"CVKD","filing_date":"2026-08-31"}]}
