News & Events zu Cadrenal Therapeutics Inc (CVKD)CVKDCadrenal Therapeutics Inc

Cadrenal Therapeutics Aligns on CAD-1005 Trial Protocol with FDA

Cadrenal Therapeutics announced feedback from a Type D Meeting with the FDA held on July 28. During the meeting, Cadrenal and the FDA aligned on aspects of the protocol and Statistical Analysis Plan for the Phase 3 registrational study of CAD-1005, the company's 12-lipoxygenase inhibitor in development to treat heparin-induced thrombocytopenia. During the Type D meeting, the FDA agreed on an optimized definition of worsening HIT for the primary endpoint, based on progression of thrombotic events through Day 14 of treatment or hospital discharge. The updated composite primary endpoint will measure the proportion of Serotonin Release Assay-positive participants with adjudicated new or worsening composite thromboembolic events through Day 14 or hospital discharge. Additionally, the FDA agreed to use placebo control in the Phase 3 trial, with standard anticoagulation therapeutics for both the CAD-1005 and placebo control arms.

Cadrenal Therapeutics Files to Sell 2.94M Shares of Common Stock

Cadrenal Therapeutics files to sell 2.94M shares of common stock for holders

Cadrenal Therapeutics CAD-1005 Clinical Data Significantly Improves Thrombotic Events

Cadrenal Therapeutics announced that late-breaking clinical data from the Phase 2 study of the 12-lipoxygenase inhibitor CAD-1005 were featured in a highly anticipated late-breaking oral presentation at the International Society on Thrombosis and Haemostasis 2026 Congress in Paris. Unlike standard-of-care anticoagulants that only reduce thrombin generation, CAD-1005 is designed to directly block the underlying 12-LOX immune signaling loop that drives antibody-mediated platelet activation. Patients treated with CAD-1005 experienced a reduction of more than 25% in new or worsening thrombotic events compared with the placebo arm, despite the study not being sufficiently powered for statistical significance. No serious adverse events attributable to CAD-1005, no major bleeding in SRA+ patients, and no deaths. Treatment with CAD-1005 was associated with fewer thromboembolic events without an increase in major bleeding. The trial established that the traditional platelet count recovery rate is an inadequate surrogate for clinical efficacy, as thrombotic events continued to occur after recovery.