Friday, May 01, 2026
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Phase 3 Design Announced. Cadrenal held an end-of-Phase-2 meeting with the FDA to discuss the results of the CAD-1005 trial and receive guidance for the design of Phase 3. Following the receipt of the Meeting Minutes, the preliminary design for Phase 3 in HIT (Heparin-Induced Thrombocytopenia) has been announced. The trial is expected to begin in late FY2026 to early FY2027, with an NDA possible in FY2019.
HIT Is A Serious Condition. HIT is a potentially life-threatening immune reaction to heparin, an anticoagulant currently used in an estimated 12 million cardiac surgeries. HIT affects up to 5% of these patients, forming immune complexes that can activate platelets and cause excessive clotting. About 50% experience thrombosis, as well as embolisms, skin necrosis, and other cardiac events that can be fatal. CAD-1005 is a selective inhibitor of the 12-LOX immune pathway that causes HIT. This contrasts with other drugs that control symptoms and secondary morbidities following the immune response.
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