FBIO Fortress Biotech

Fortress Biotech, Inc. · FDA approves Zycubo (copper histidinate)

FDA lists Zycubo (copper histidinate) as novel drug approval #1 of 2026 on 2026-01-12: To treat Menkes disease Drug Trials Snapshot

Fortress Biotech: FDA sets Jan 14 2026 PDUFA for CUTX-101 NDA

FDA accepted the Class 1 resubmission of the CUTX-101 NDA and assigned a new PDUFA target action date of January 14, 2026. The CRL issued on September 30, 2025 was limited to manufacturing-site cGMP observations; no efficacy or safety deficiencies were cited.

Fortress Biotech: Sentynl resubmits NDA for CUTX-101 (Menkes disease)

Sentynl resubmitted the NDA for CUTX-101 to the FDA on November 14, 2025. Fortress/Cyprium retains ownership of any Priority Review Voucher and remains eligible for up to $129 million in milestones plus royalties. The resubmission follows the October 2025 Complete Response Letter.

Fortress Biotech: FDA issues CRL for CUTX-101 NDA

FDA issued a Complete Response Letter for the CUTX-101 NDA citing cGMP deficiencies at the manufacturing facility. The CRL did not identify any deficiencies in efficacy or safety data. Sentynl, the partner now responsible for development, plans to address the issues and resubmit the NDA.