Fortress Biotech (FBIO) and its majority-owned subsidiary, Cyprium Therapeutics, announced that the U.S. Food and Drug Administration has approved ZYCUBO for the treatment of Menkes disease in pediatric patients. In December 2023, Sentynl Therapeutics assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. A Rare Pediatric Disease Priority Review Voucher was issued in connection with FDA approval and, pursuant to the transaction with Sentynl, will be transferred to Cyprium. Cyprium is also eligible to receive tiered royalties on net sales of ZYCUBO and up to $129M in aggregate development and sales milestones from Sentynl.
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