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Details:
Nulibry (fosdenopterin) is a first-in-class cPMP substrate replacement therapy that was approved by the U.S. Food and Drug Administration (FDA) in 2021 to reduce the risk of mortality in patients with MoCD Type A.
Lead Product(s): Fosdenopterin
Therapeutic Area: Rare Diseases and Disorders Product Name: Nulibry
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sentynl Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2022
Details:
NULIBRY (fosdenopterin) is first and only approved therapy in U.S. and in Israel to treat patients with MoCD Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants with a median overall survival age of about four years.
Lead Product(s): Fosdenopterin
Therapeutic Area: Genetic Disease Product Name: Nulibry
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sentynl Therapeutic
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2022
Details:
CHMP recommendation for approval of NULIBRY (fosdenopterin) in European Union (EU) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A is based on the efficacy and safety data collected to date compared to data from a natural history study.
Lead Product(s): Fosdenopterin
Therapeutic Area: Rare Diseases and Disorders Product Name: Nulibry
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sentynl Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2022
Details:
Under the Agreement, Sentynl will acquire global rights to NULIBRY and will be responsible for the ongoing development and commercialization of NULIBRY in the United States and developing, manufacturing and commercializing Fosdenopterin globally.
Lead Product(s): Fosdenopterin
Therapeutic Area: Rare Diseases and Disorders Product Name: Nulibry
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sentynl Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 08, 2022
Details:
The efficacy of NULIBRY for the treatment of patients with MoCD Type A was established based on data from three clinical trials compared to data from a natural history study in which it showed a meaningful increase in overall survival compared to a natural history study.
Lead Product(s): Fosdenopterin
Therapeutic Area: Genetic Disease Product Name: Nulibry
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 28, 2021
Details:
FDA has accepted its New Drug Application (NDA) for fosdenopterin, a cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy, for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.
Lead Product(s): Fosdenopterin
Therapeutic Area: Genetic Disease Product Name: ORGN001
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 September 29, 2020
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