[{"orgOrder":0,"company":"Fortress Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fortress Biotech Announces Publication of Study on Estimated Birth Prevalence of Menkes Disease in\nMolecular Genetics and Metabolism Reports","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Fortress Biotech","sponsor":"Cyprium Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fortress Biotech Gets Positive Opinion on Orphan Drug Designation Received from the EMA for CUTX-101","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Cyprium Therapeutics","sponsor":"Sentynl Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$20.0 million","newsHeadline":"Cyprium Therapeutics and Sentynl Therapeutics Sign Development and Asset Purchase Agreement","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Fortress Biotech","sponsor":"Cyprium Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fortress Biotech and Cyprium Therapeutics Announce Positive Clinical Data for CUTX-101, Copper Histidinate, Presented at 2021 American Academy of Pediatrics National Conference & Exhibition","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Cyprium Therapeutics","sponsor":"Fortress Biotech","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"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","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Cyprium Therapeutics","sponsor":"Sentynl Therapeutics","pharmaFlowCategory":"D","amount":"$133.5 million","upfrontCash":"Undisclosed","newsHeadline":"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","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Cyprium Therapeutics","sponsor":"National Institute of Neurological Disorders and Stroke","pharmaFlowCategory":"D","amount":"$4.1 million","upfrontCash":"Undisclosed","newsHeadline":"Fortress Biotech and Cyprium Therapeutics Announce $4.1 Million Grant from NINDS to Further Development of AAV-ATP7A Gene Therapy for Menkes Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"}]
Find Clinical Drug Pipeline Developments & Deals for Copper Histidine
The funding is intended to aid in the finalization of Cyprium's primary candidate, currently undergoing preclinical trials involving AAV-ATP7A in conjunction with CUTX-101 for addressing Menkes Disease.
Under the agreement, Cyprium completed the transfer of its proprietary rights and assigned its FDA documents pertaining to CUTX-101 (copper histidinate) product candidate for the treatment of Menkes disease, to Sentynl.
CUTX-101, a subcutaneous injectable formulation of Copper Histidinate has potential to be first FDA-approved treatment for Menkes disease; rolling submission of New Drug Application to FDA is ongoing and expected to be completed in mid-year 2022.
In two completed open-label, single-arm, single-site studies, 129 patients with Menkes disease were treated with CUTX-101 administered subcutaneously twice daily until 12 months of age, and once daily thereafter, for a total duration of up to three years.
Sentynl has signed an agreement with Cyprium to contribute research funding for CUTX-101, a Copper Histidinate product candidate for the treatment of Menkes disease, and to purchase Cyprium's proprietary rights to CUTX-101.
Orphan Drug Designation in the European Union (“EU”) is granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products.
Cyprium Therapeutics, a Fortress partner company, is developing CUTX-101 for Menkes disease and is
on track to begin submitting a rolling New Drug Application to the FDA.
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