Sentynl Therapeutics, a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences and Fortress Biotech (FBIO), announced that the U.S. Food and Drug Administration has accepted for filing and Priority review Sentynl’s New Drug Application for CUTX-101, the product candidate for the treatment of Menkes disease. Menkes disease is 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.
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