Market reaction and headline results
Shares of Cadrenal Therapeutics Inc (NASDAQ:CVKD) rose 11% on Tuesday after the company disclosed topline data from a Phase 2 study of CAD-1005 in patients with heparin-induced thrombocytopenia, or HIT. Management highlighted a lower incidence of thrombotic events among patients treated with CAD-1005 compared with those receiving placebo, even though all participants received standard anticoagulant therapy.
Trial design and outcomes
The study was a randomized, blinded, placebo-controlled Phase 2 trial enrolling 24 patients with presumptive HIT. CAD-1005, described by the company as a selective inhibitor of 12-lipoxygenase, was evaluated against placebo on top of routine anticoagulation. According to the report, the placebo arm experienced a thrombotic event rate in excess of 75%, while the CAD-1005 arm had a 50% event rate. The company noted the trial was not powered to provide statistical significance for that observation.
Cadrenal also reported that the study did not meet its primary endpoint. Platelet count recovery rates were similar between the CAD-1005 and placebo groups. The company observed that thrombotic events continued to occur after platelet count recovery in patients from both arms.
Regulatory and program status
Cadrenal has scheduled an End-of-Phase 2 meeting with the U.S. Food and Drug Administration for March 2026 to discuss a potential Phase 3 registration strategy. The company acquired the CAD-1005 program from Veralox Therapeutics, and the study concluded in December 2025 following the ownership transfer. CAD-1005 has received Orphan Drug Designation and Fast Track designation from the FDA, as well as orphan designation from the European Medicines Agency.
Clinical context provided by the company
The company reiterated that HIT is a potentially life-threatening immune-mediated complication occurring in patients who receive heparin. The filing referenced that more than 12 million patients receive heparin each year in the United States, and that mortality rates for HIT exceed 20% in some studies. Cadrenal positions CAD-1005 as targeting the underlying immune mechanisms driving HIT, in contrast with currently available therapies that the company says address thrombotic complications rather than the underlying immune drivers.
Study enrollment and history
The trial was originally planned to enroll 60 patients but was stopped in December 2025 after the program transfer, resulting in the 24-patient dataset reported. Cadrenal characterized the results as encouraging with respect to observed thrombotic event rates, while also acknowledging the primary endpoint was not met and the study size limited statistical conclusions.
Readers should note that the company has communicated plans to discuss a Phase 3 pathway with regulators in March 2026. The data reported include both efficacy signals and limitations tied to trial size and endpoints.