

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Fortress Biotech
Deal Size : Inapplicable
Deal Type : Inapplicable
Sentynl Therapeutics Announces FDA Acceptance of CUTX-101 for Menkes Disease
Details : CUTX-101 is a subcutaneous injectable formulation of copper histidinate, which is being evaluated for the treatment of menkes disease.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
January 06, 2025
Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Fortress Biotech
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : AAV-ATP7A,Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Preclinical
Sponsor : National Institute of Neurological Disorders and Stroke
Deal Size : $4.1 million
Deal Type : Funding
Fortress Biotech and Cyprium Announce Grant from NINDS for AAV-ATP7A Gene Therapy
Details : 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 Menkes Disease.
Product Name : Undisclosed
Product Type : Cell & Gene Therapy
Upfront Cash : Undisclosed
March 04, 2024
Lead Product(s) : AAV-ATP7A,Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Preclinical
Sponsor : National Institute of Neurological Disorders and Stroke
Deal Size : $4.1 million
Deal Type : Funding

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Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Sentynl Therapeutics
Deal Size : $133.5 million
Deal Type : Agreement
Details : 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.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Undisclosed
December 06, 2023
Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Sentynl Therapeutics
Deal Size : $133.5 million
Deal Type : Agreement

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Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Fortress Biotech
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : 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.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
March 21, 2022
Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Fortress Biotech
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Cyprium Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : 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...
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
October 08, 2021
Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Cyprium Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Sentynl Therapeutics
Deal Size : Undisclosed
Deal Type : Acquisition
Cyprium Therapeutics and Sentynl Therapeutics Sign Development and Asset Purchase Agreement
Details : 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.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : $20.0 million
February 24, 2021
Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Sentynl Therapeutics
Deal Size : Undisclosed
Deal Type : Acquisition

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Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Cyprium Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Fortress Biotech Gets Positive Opinion on Orphan Drug Designation Received from the EMA for CUTX-101
Details : 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.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
July 31, 2020
Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Cyprium Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : 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.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
June 11, 2020
Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : If Cyprium’s new drug application is approved, the company may be eligible to receive a priority review voucher.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
January 16, 2020
Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Undisclosed
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Copper Histidinate Treatment for Menkes Disease
Details : Copper Histidinate is a drug candidate, which is currently being evaluated in clinical studies for the treatment of Menkes Kinky Hair Syndrome.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
August 30, 2019
Lead Product(s) : Copper Histidine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Undisclosed
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
