Fortress Biotech Inc. and its majority-owned subsidiary, Cyprium Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for CUTX-101, a treatment for Menkes disease in pediatric patients. The NDA resubmission has been classified as a Class 1 resubmission, setting a new Prescription Drug User Fee Act (PDUFA) target action date of January 14, 2026. Sentynl Therapeutics, which assumed full responsibility for the development and commercialization of CUTX-101 in December 2023, resubmitted the NDA following a complete response letter from the FDA regarding manufacturing site compliance. No deficiencies were cited in the therapy's efficacy or safety data.