Fortress Biotech, Inc. (FBIO) and its majority-owned subsidiary, Cyprian Therapeutics, Inc., on Tuesday said the U.S. Food and Drug Administration has approved ZYCUBO for the treatment of Menkes disease in pediatric patients. Until now, there has been no approved treatment for the rare disorder in the United States.
Menkes disease is a rare X-linked recessive pediatric disorder caused by mutations in the copper transporter ATP7A gene.
In December 2023, Sentynl Therapeutics, a unit of Zydus Lifesciences, secured the rights to develop and commercialize ZYCUBO from Cyprium. Under the agreement with Sentynl, a Rare Pediatric Disease Priority Review Voucher (PRV) issued with FDA approval will be transferred to Cyprium. The company is also eligible for tiered royalties on ZYCUBO sales and up to $129 million in development and sales milestones from Sentynl.
The approval is supported by positive topline clinical results, which showed that early treatment with ZYCUBO significantly improved overall survival in Menkes disease patients compared with an untreated contemporaneous external control cohort, reducing the risk of death by nearly 80%.
Fortress Biotech shares rose more than 5% in pre-market trading, after closing at $4.20 on Monday, down 2.32%.
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