CVKD News & Events

Cadrenal Therapeutics announced plans to submit a Rare Pediatric Disease Designation, RPDD, request to the U.S. Food and Drug Administration, FDA, for tecarfarin as a treatment for pediatric patients with Kawasaki disease who develop coronary artery aneurysms, CAAs, and require chronic oral anticoagulation. The announcement comes ahead of the BIO International Convention, June 22-25, 2026, in San Diego, California. Cardenal's executive leadership team will highlight this rare pediatric initiative and its Phase 3-ready CAD-1005 platform during one-on-one partnering meetings with global and regional pharmaceutical companies.

Cadrenal Therapeutics announced that it plans to initiate a Phase 2a proof-of-concept clinical trial of its lead drug candidate, CAD-1005, being studied to prevent Acute Kidney Injury in high-risk patients undergoing cardiac surgery. The trial is expected to begin later this year.

Cadrenal Therapeutics announced a regulatory milestone after completing its End-of-Phase 2 meeting with the FDA and receiving guidance on key elements of the Phase 3 pivotal trial for CAD-1005, the company's investigational first-in-class 12-lipoxygenase inhibitor for heparin-induced thrombocytopenia. The meeting with the FDA provided critical guidance on protocol design, study population, dosing, background therapy, exposure, the safety database, and the primary endpoint of new or worsening thrombotic events. After considering FDA feedback on a pivotal registration study, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT.

Cadrenal Therapeutics files to sell 1.18M shares of common stock for holders