Cadrenal gets FDA alignment on Phase 3 endpoint for CAD-1005 in HIT

Cadrenal Therapeutics, Inc.

• FDA Type D meeting July 28, 2026; agreed on primary endpoint definition for worsening HIT through Day 14 or discharge.
• Primary endpoint: proportion of SRA+ participants with adjudicated new or worsening composite thromboembolic events through Day 14 or hospital discharge.
• FDA agreed to placebo control with standard anticoagulation for both CAD-1005 and placebo arms.
• HIT affects ~50,000 patients annually in U.S.; CAD-1005 projected $2B peak annual revenue.
• Phase 3 will assess bleeding as major safety endpoint using ISTH criteria.