Cyprium Therapeutics, Inc.

Recent Press Releases

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

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

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

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

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

January 2020 :: Fortress Biotech Announces Rare Pediatric Disease Designation For CUTX-101 For The Treatment of Menkes Disease