Cadrenal Therapeutics (CVKD) – Tecarfarin Receives Orphan Drug Designation For Second Indication

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Friday, April 12, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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Orphan Designation Received For Circulatory Assist Devices. Cadrenal Therapeutics has received Orphan Drug designation for tecarfarin as an anticoagulant in patients with circulatory-assist devices, including ventricular assist devices (VADs) and total artificial hearts. This is the second Orphan designation for tecarfarin. The first indication, atrial fibrillation associated with end stage renal disease (AFib with ESRD), is expected to begin a Phase 3 trial in 2Q24.

Circulatory Assist Device Patients Do Not Have Effective Anticoagulants. Mechanical devices to assist blood circulation can activate the clotting cascade, putting patients who receive them at risk of clots or thromboembolisms. Commonly used anticoagulants in the direct oral anticoagulant (DOAC) category have not shown efficacy in these patients and have been contraindicated. This leaves the patients at high risk for thromboembolic events and hospitalizations.

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