On August 31, 2026, Cadrenal Therapeutics announced positive feedback from a July 28 FDA Type D meeting regarding the Phase 3 registrational study protocol for CAD-1005. The FDA aligned on an optimized primary endpoint measuring new or worsening composite thromboembolic events through Day 14 or hospital discharge in Serotonin Release Assay-positive participants. The agency also approved a placebo-controlled design with standard anticoagulation for both arms. Cadrenal Therapeutics is a late-stage biopharmaceutical company developing therapies for critical care cardiology and orphan cardiovascular conditions.
