Fortress Biotech (FBIO) and its majority-owned subsidiary, Cyprium Therapeutics announced the acceptance for review of the New Drug Application by the U.S. Food and Drug Administration for CUTX-101 for the treatment of Menkes disease, a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A. The NDA has been granted Priority Review and assigned a Prescription Drug User Fee Act target action date of June 30, 2025.
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