FDA extends PDUFA date for Fortress subsidiary's NDA for CUTX-101 to Sep 30, 2025

Fortress Biotech, Inc.

FDA extended target action date for CUTX-101 (Copper Histidinate) NDA to September 30, 2025.
Sentynl assumed full responsibility for CUTX-101 development and commercialization in Dec 2023.
Cyprium retains ownership of any Priority Review Voucher; eligible for up to $129M milestones plus royalties.
Fortress owns approximately 76% of Cyprium Therapeutics.

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