Cadrenal Therapeutics says FDA agreed on Phase 3 endpoint and placebo control for CAD-1005
Cadrenal Therapeutics said that at a Type D meeting with the U.S. Food and Drug Administration held July 28, 2026, the company and the FDA aligned on key aspects of the protocol and Statistical Analysis Plan for a Phase 3 registrational study of CAD-1005 in heparin-induced thrombocytopenia (HIT). The filing says the agreement sets the primary endpoint definition and the use of a placebo control, which the company says clarifies the regulatory path, but it does not disclose financial results, costs, or a trial start date.
Key points
- Type D meeting with the FDA held July 28, 2026; the company announced the feedback on August 31, 2026.
- Primary endpoint measures the proportion of Serotonin Release Assay-positive participants with adjudicated new or worsening composite thromboembolic events through Day 14 or hospital discharge.
- The FDA agreed to a placebo control, with standard anticoagulation therapeutics in both the CAD-1005 and placebo arms.
- The company states that approximately 50,000 patients in the U.S. have acute HIT each year.
The filing
Written by AI on Nov 9, 2026, 11:44 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on August 31, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.