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Details:
AT-007 (govorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI), which is in phase 3 clinical development for the treatment of Classic Galactosemia.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 March 28, 2024
Details:
The Company intends to use the net proceeds to fund the clinical development of AT-007 (govorestat), a novel aldose reductase Inhibitor. It is being evaluated in patients for the treatment of Galactosemia.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Perceptive Advisors
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement February 28, 2024
Details:
AT-007 (govorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI), which is in phase 3 clinical development for the treatment of Classic Galactosemia.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 February 28, 2024
Details:
AT-007 (govorestat) is a cns penetrant aldose reductase inhibitor. It is being evaluated for the treatment of hereditary neuropathy caused by SORD deficiency.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 February 15, 2024
Details:
AT-007 (govorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI), which is in phase 3 clinical development for the treatment of Classic Galactosemia.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 January 03, 2024
Details:
AT-007 (govorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in development for the treatment of several rare neurological diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 06, 2023
Details:
AT-007 (govorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in development for the treatment of several rare neurological diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 July 25, 2023
Details:
AT-007 (govorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in development for the treatment of several rare neurological diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG.
Lead Product(s): Govorestat
Therapeutic Area: Rare Diseases and Disorders Product Name: AT-007
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 May 25, 2023
Details:
AT-007 (govorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in development as a potential first-ever treatment for this rare genetic disease that can be life-threatening for newborns and cause severe lifelong complications.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 April 26, 2023
Details:
The Company intends to use the net proceeds to fund research and development and registration of its pipeline candidates, including AT-007 (gavorestat) an investigational, novel Aldose Reductase Inhibitor (ARI) being developed for the treatment of several rare diseases.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Venrock Healthcare Capital Partners
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement April 24, 2023
Details:
AT-007 (govorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in development for the treatment of several rare neurological diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 April 24, 2023
Details:
AT-007 (gavorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in development for the treatment of several rare neurological diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2023
Details:
AT-007 (gavorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in development for the treatment of several rare neurological diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Advanz Pharma
Deal Size: $138.4 million Upfront Cash: $10.6 million
Deal Type: Partnership January 04, 2023
Details:
AT-007 (gavorestat) is a CNS penetrant Aldose Reductase inhibitor (ARI) in development for the treatment of several rare neurological diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. afety data demonstrated that AT-007 continues to be safe and well tolerated.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 October 06, 2022
Details:
AT-007 (gavorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in development for the treatment of several rare neurological diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 July 28, 2022
Details:
The Company intends to use the net proceeds from offering for general purposes which may include research and development costs, including the conduct of clinical trials and process development and manufacturing of the Company’s product candidate AT-007, having gavorestat .
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Securities
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 23, 2022
Details:
AT-007 (Gavorestat) is a central nervous system (CNS) penetrant Aldose Reductase inhibitor, in clinical trials, AT-007 significantly reduced plasma galactitol levels vs. placebo in adults and children with Galactosemia.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 03, 2022
Details:
Sorbitol elevation results in mitochondrial dysfunction, neuronal loss, and climbing defects in a drosophila model of SORD Deficiency; AT-007 (gavorestat) treatment in drosophila prevents all aspects of the SORD Deficiency phenotype by reducing sorbitol production.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
AT-007 is a central nervous system penetrant aldose reductase inhibitor in development for the treatment of several rare neurological diseases, in an animal model of Galactosemia, AT-007 reduced toxic galactitol levels and prevented disease complications.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2022
Details:
AT-007 is a central nervous system (CNS) penetrant Aldose Reductase inhibitor, In clinical trials, AT-007 significantly reduced plasma galactitol levels vs. placebo in adults and children with Galactosemia.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
FDA indicated that clinical outcome data will likely be required for approval of AT-007 (Gavorestat) on the basis of the discussion company has decided to hold on submitting an NDA for AT-007 for treatment of Galactosemia.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
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 January 03, 2022
Details:
AT-007 is the Company’s central nervous system-penetrant Aldose Reductase inhibitor in development for multiple rare metabolic disorders, including Galactosemia, SORD and PMM2-CDG. AT-007 reduced toxic galactitol levels and prevented disease complications
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2021
Details:
FDA has lifted the hold and the AT-007 ACTION-Galactosemia Kids pediatric clinical study will resume effective immediately. Dose-escalation portion of the study has been operationally modified to ensure continuous drug treatment and participation throughout the study.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2021
Details:
The presentations include animal model efficacy data and adult clinical data on the safety and biomarker efficacy of Applied Therapeutics’ investigational candidate for Galactosemia, AT-007, a Central Nervous System (CNS) penetrant Aldose Reductase Inhibitor (ARI).
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: AT-007
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
Details:
AT-007, a novel CNS penetrant Aldose Reductase inhibitor (recently given the INN scientific name gavorestat) has demonstrated biological activity in a validated model of PMM2-CDG.
Lead Product(s): Govorestat
Therapeutic Area: Rare Diseases and Disorders Product Name: AT-007
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2020
Details:
Applied Therapeutics announced additional supportive biomarker efficacy and safety data for AT-007 in Galactosemia at 40 mg/kg. The company also announced initiation of the AT-007 pediatric trial, ACTION-Galactosemia Kids, in children age 2 to 17.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
AT-007 demonstrated rapid and sustained reduction in toxic galactitol levels with no accompanying increase in galactose.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2020
Details:
AT-007 demonstrated a robust and sustained reduction in galactitol vs placebo; significant plasma galactitol reduction of ~50%.
Lead Product(s): Govorestat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2020
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