Fortress, Cyprium announce FDA acceptance, priority review of NDA for CUTX-101

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.