Tuesday, September 01, 2026
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Phase 3 Design Can Move Forward With Expected Endpoints. Cadrenal announced that it held a Type D meeting with the FDA and has reached agreement on the design of the Phase 3 trial to test CAD-1005 in HIT (heparin-induced thrombocytopenia). This includes the primary endpoint, the protocol, and the statistical analysis plan (SAP). We see this as a significant step for the product and for the company’s plan to pursue collaboration to develop CAD-1005.
Primary and Secondary Endpoints Have Been Defined. The primary endpoint will be worsening HIT, defined as progression of thrombotic events through treatment day 14 or hospital discharge. A composite score composed of several aspects of thrombotic events will be used to measure progression. These include extension of an existing thrombus and the proportion of Serotonin Release Assay-positive (SRA+) patients with worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge.
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