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Sentnyl’s NDA for CUTX-101 Accepted by FDA for Filing and Priority Review

Has potential to be the first FDA-approved treatment for Menkes disease, a rare and fatal pediatric disease.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has accepted Sentynl Therapeutics Inc.’s New Drug Application (NDA) for CUTX-101 for filing and Priority review. CUTX-101 is a product candidate for the treatment of Menkes disease, a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A. Recent estimates suggest a prevalence of 1 in 34,810 to as high as 1 in 8,664 live male births. Sentynl’s NDA is supported by positive topline clinical ef...

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