FDA accepts Cyprium's NDA for CUTX-101 for priority review; action date June 30, 2025

Fortress Biotech, Inc.

FDA granted priority review to CUTX-101 (Copper Histidinate) NDA for treating Menkes disease.
Target PDUFA action date is June 30, 2025; Sentynl (Zydus Group) will commercialize upon approval.
Cyprium retains any Priority Review Voucher and is eligible for up to $129M in milestones plus royalties.
Fortress Biotech owns ~76% of Cyprium, founded in 2017.

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