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Cadrenal Therapeutics to Seek US FDA's Rare Pediatric Disease Designation for Tecarfarin to Treat Children With Kawasaki Disease

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Cadrenal Therapeutics (CVKD) will submit a request to the US Food and Drug Administration to receive rare pediatric disease designation for tecarfarin to treat children with Kawasaki disease who develop coronary artery aneurysms and require chronic oral anticoagulation, the drugmaker said Thursday.

The designation is intended to provide incentives for companies developing drugs for rare pediatric diseases, and Cadrenal may receive a voucher that can be redeemed to secure priority review for a different product if the designation is granted, it said.

Tecarfarin offers potential advantages over warfarin, which is the current standard Vitamin K antagonist in clinical use, as tecarfarin is intended to overcome limitations of warfarin metabolism and could provide more reliable and consistent anticoagulation than warfarin, the company said.

Shares of Cadrenal Therapeutics were up 8.3% in early Thursday trading.

Price: $3.36, Change: $+0.26, Percent Change: +8.32%

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