FDA Approves Fortress Biotech’s ZYCUBO for Menkes Disease

Reuters01-13

FDA Approves Fortress Biotech’s ZYCUBO for Menkes Disease

Fortress Biotech Inc. and its majority-owned subsidiary, Cyprium Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has approved ZYCUBO® (copper histidinate) for the treatment of Menkes disease in pediatric patients. This marks the first and only FDA-approved treatment for this rare disease in the United States. In connection with the approval, a Rare Pediatric Disease Priority Review Voucher (PRV) was granted by the FDA and will be transferred from Sentynl Therapeutics to Cyprium. Cyprium is also eligible to receive tiered royalties and up to $129 million in aggregate development and sales milestones from Sentynl Therapeutics, which assumed responsibility for the development and commercialization of ZYCUBO in December 2023. The approval was based on clinical results showing a significant improvement in overall survival for patients who received early treatment with ZYCUBO.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Fortress Biotech Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9624722) on January 13, 2026, and is solely responsible for the information contained therein.

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This marks the first and only FDA-approved treatment for this rare disease in the United States. In connection with the approval, a Rare Pediatric Disease Priority Review Voucher (PRV) was granted by the FDA and will be transferred from Sentynl Therapeutics to Cyprium. Cyprium is also eligible to receive tiered royalties and up to $129 million in aggregate development and sales milestones from Sentynl Therapeutics, which assumed responsibility for the development and commercialization of ZYCUBO in December 2023. The approval was based on clinical results showing a significant improvement in overall survival for patients who received early treatment with ZYCUBO.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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This marks the first and only FDA-approved treatment for this rare disease in the United States. In connection with the approval, a Rare Pediatric Disease Priority Review Voucher (PRV) was granted by the FDA and will be transferred from Sentynl Therapeutics to Cyprium. Cyprium is also eligible to receive tiered royalties and up to $129 million in aggregate development and sales milestones from Sentynl Therapeutics, which assumed responsibility for the development and commercialization of ZYCUBO in December 2023. The approval was based on clinical results showing a significant improvement in overall survival for patients who received early treatment with ZYCUBO.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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