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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 addressing Menkes Disease.
Lead Product(s): AAV-ATP7A,Copper Histidine
Therapeutic Area: Genetic Disease Product Name: AAV-ATP7A
Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: National Institute of Neurological Disorders and Stroke
Deal Size: $4.1 million Upfront Cash: Undisclosed
Deal Type: Funding March 04, 2024
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.
Lead Product(s): Copper Histidine
Therapeutic Area: Genetic Disease Product Name: CUTX-101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sentynl Therapeutics
Deal Size: $133.5 million Upfront Cash: Undisclosed
Deal Type: Agreement December 06, 2023
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.
Lead Product(s): Copper Histidine
Therapeutic Area: Genetic Disease Product Name: CUTX-101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Fortress Biotech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
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.
Lead Product(s): Copper Histidine
Therapeutic Area: Genetic Disease Product Name: CUTX-101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cyprium Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2021
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.
Lead Product(s): Copper Histidine
Therapeutic Area: Genetic Disease Product Name: CUTX-101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sentynl Therapeutics
Deal Size: Undisclosed Upfront Cash: $20.0 million
Deal Type: Acquisition February 24, 2021
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.
Lead Product(s): Copper Histidine
Therapeutic Area: Genetic Disease Product Name: CUTX-101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cyprium Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 31, 2020
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.
Lead Product(s): Copper Histidine
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
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