Fortress Biotech Receives FDA Approval for ZYCUBO to Treat Pediatric Menkes Disease

Tuesday, Jan 13, 2026 9:13 am ET1min read
FBIO--

Fortress Biotech and its subsidiary Cyprium Therapeutics announced FDA approval of ZYCUBO for pediatric Menkes disease, a rare disorder caused by mutations in the copper transporter ATP7A gene. The approval is supported by positive topline clinical results that showed early treatment with ZYCUBO improved overall survival in patients by nearly 80%. The FDA approval marks the first approved treatment for Menkes disease in the US.

Fortress Biotech Receives FDA Approval for ZYCUBO to Treat Pediatric Menkes Disease

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