Sentynl Therapeutics Reports US FDA Approval of Zycubo to Treat Pediatric Menkes Disease

Shots: The US FDA has approved Zycubo (copper histidinate) for the treatment of pediatric patients with Menkes disease Approval was supported by clinical data showing improved OS with early Zycubo treatment vs an untreated external control, reflecting ~80% reduction in the risk of death & a mOS of 177.1 vs 17.6mos. Zycubo is a bioavailable…

ByRidhi RastogiJanuary 14, 2026

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Fortress Biotech and Cyprium Therapeutics Report the US FDA’s NDA Acceptance with Priority Review of CUTX-101 to Treat Menkes Disease

Shots: Fortress and its subsidiary, Cyprium, have reported the US FDA’s NDA acceptance & priority review of CUTX-101 (copper histidinate) to treat Menkes disease, with the decision expected on Jun 30, 2025 Submission was based on a trial of CUTX-101 vs untreated historical control that depicted significantly improved OS & an 80% reduction in…

BySenior EditorJanuary 7, 2025

Sentynl Therapeutics Reports US FDA Approval of Zycubo to Treat Pediatric Menkes Disease

Fortress Biotech and Cyprium Therapeutics Report the US FDA’s NDA Acceptance with Priority Review of CUTX-101 to Treat Menkes Disease

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