Press Releases

March 30, 2026 :: Fortress Biotech’s Subsidiary Cyprium Therapeutics Closes Sale of Rare Pediatric Disease Priority Review Voucher for $205 Million

February 23, 2026 :: Fortress Biotech’s Subsidiary Cyprium Therapeutics Enters into Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $205 Million

January 13, 2026 :: Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Approval of ZYCUBO® (copper histidinate), the First and Only Approved Treatment for Menkes Disease in the United States

December 15, 2025 :: Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA Resubmission

October 1, 2025 :: Fortress Biotech and Cyprium Therapeutics Announce an Update on the NDA for CUTX-101

January 6, 2025 :: Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease

March 4, 2024 :: Fortress Biotech and Cyprium Therapeutics Announce $4.1 Million Grant from NINDS to Further Development of AAV-ATP7A Gene Therapy for Menkes Disease

December 6, 2023 :: Cyprium Therapeutics, a Fortress Biotech Subsidiary Company, Completes Asset Transfer of CUTX-101 Copper Histidinate Product Candidate for Treatment of Menkes Disease, to Sentynl Therapeutics, a Wholly-owned Subsidiary of Zydus Lifesciences Ltd.

March 21, 2022 :: Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics Announce CUTX-101, Copper Histidinate, Data to be Presented at 2022 American College of Medical Genetics Annual Clinical Genetics Meeting

December 7, 2021: Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics Announce the Initiation of Rolling Submission of a New Drug Application for CUTX-101, Copper Histidinate, for Treatment of Menkes Disease

October 8, 2021: Fortress Biotech and Cyprium Therapeutics Announce Positive Clinical Data for CUTX-101, Copper Histidinate, Presented at 2021 American Academy of Pediatrics National Conference & Exhibition

February 24, 2021: Cyprium Therapeutics, a Fortress Biotech Partner Company, and Sentynl Therapeutics, a Wholly-owned Subsidiary of the Zydus Group, Sign Development and Asset Purchase Agreement for Cyprium Therapeutics’ Copper Histidinate Product Candidate for Treatment of Menkes Disease

December 15, 2020:Fortress Biotech Announces Breakthrough Therapy Designation for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease

August 28, 2020: Fortress Biotech Announces Positive Topline Clinical Efficacy Results for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease

July 31, 2020: Fortress Biotech Announces Positive Opinion on Orphan Drug Designation Received from the European Medicines Agency for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease

July 29, 2020: Fortress Biotech Announces Publication of Study on Targeted Next Generation Sequencing for Newborn Screening of Menkes Disease in Molecular Genetics and Metabolism Reports

June 11, 2020: Fortress Biotech Announces Publication of Study on Estimated Birth Prevalence of Menkes Disease in Molecular Genetics and Metabolism Reports

January 16, 2020: Fortress Biotech Announces Rare Pediatric Disease Designation for CUTX-101 for the Treatment of Menkes Disease

September 12, 2018: Fortress Biotech Announces Publication of Preclinical Data on AAV-ATP7A Gene Therapy Combined with CUTX-101 (Copper Histidinate) for Menkes Disease in Molecular Therapy: Methods & Clinical Development

July 2, 2018: Fortress Biotech Announces Cyprium Therapeutics’ CUTX-101 (Copper Histidinate) Granted FDA Fast Track Designation for Treatment of Classic Menkes Disease

March 14, 2017: Fortress Biotech Forms New Subsidiary, Cyprium Therapeutics, Inc., to Develop Novel Therapies for Menkes Disease and Related Copper Metabolism Disorders