- The FDA has granted a Fast Track designation to Cadrenal Therapeutics Inc’s CVKD tecarfarin for the prevention of systemic thromboembolism, more commonly referred to as blood clots, of cardiac origin in patients with end-stage renal disease (ESRD) and atrial fibrillation (AFib).
- Fast Track is a process designed to facilitate the development and expediting of the review of drugs to treat serious conditions. Fast Track aims to get important new drugs to the patient earlier.
- The FDA had previously granted an Orphan Drug Designation (ODD) for tecarfarin. The FDA grants orphan status to drugs targeting rare diseases or disorders that affect fewer than 200,000 people in the U.S.
- The ODD program provides certain benefits and incentives, including seven years of U.S. marketing exclusivity, waiver of FDA user fees, and tax credits for clinical research.
- Tecarfarin is a Vitamin K antagonist oral anticoagulant designed to target a different pathway than the most commonly prescribed drugs used to treat thrombosis and AFib. Tecarfarin has been evaluated in eleven human clinical trials and more than 1,000 individuals.
- The stock went up by 44% today and has been volatile and given up gains since.
- Price Action: CVKD shares are up 0.61% at $4.15 on the last check Monday.
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