CVKD · Cadrenal Therapeutics, Inc. Common Stock

Cadrenal Therapeutics achieved a critical regulatory milestone by completing its End-of-Phase 2 meeting with the FDA on April 30, 2026, securing alignment on essential Phase 3 trial elements for CAD-1005, its first-in-class 12-LOX inhibitor targeting heparin-induced thrombocytopenia (HIT). The FDA provided specific guidance on protocol design, study population, dosing regimen, background therapy, exposure duration, safety database requirements, and the primary endpoint measuring new or worsening thrombotic events via central adjudication. This positions the company to proceed directly to a pivotal, randomized, blinded, placebo-controlled Phase 3 study—the first of its kind in HIT—enrolling approximately 120 patients with suspected HIT confirmed by Serotonin Release Assay (SRA) across up to 50 worldwide clinical centers. Patients will receive CAD-1005 or placebo alongside standard-of-care anticoagulant therapy for up to 14 days during hospitalization, with at least one interim analysis planned to support a projected New Drug Application (NDA) submission in 2029. Building on Phase 2 results demonstrating over 25% absolute reduction in thrombotic events when added to standard therapy, CAD-1005 addresses the underlying immune-mediated platelet activation in HIT, a condition affecting patients on heparin with high mortality exceeding 20% in some studies and no new therapies in over two decades. CAD-1005's Orphan Drug Designation, Fast Track status from the FDA, and EMA orphan designation underscore its potential to fill a significant unmet need in this life-threatening disorder.