FDA approves ZYCUBO for Menkes disease; Cyprium gets PRV, up to $129M milestones

Fortress Biotech, Inc.

FDA approved ZYCUBO (copper histidinate) as first and only U.S. treatment for Menkes disease in pediatric patients.
Rare Pediatric Disease PRV issued at approval and will be transferred to Cyprium, a majority-owned Fortress subsidiary.
Cyprium eligible for tiered royalties on net sales and up to $129M in aggregate development and sales milestones from Sentynl.
Early ZYCUBO treatment showed median overall survival of 177.1 months vs 17.6 months in external control (≈80% risk reduction).
Fortress notes three FDA approvals in 15 months (Emrosi, UNLOXCYT, ZYCUBO) and recent $28M upfront from Checkpoint sale to Sun Pharma.

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