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Details:
Under the terms of the agreements, Kyowa Kirin has an exclusive license to develop and commercialize BGJ398 (infigratinib) for the treatment of achondroplasia, hypochondroplasia, and other skeletal dysplasias in Japan.
Lead Product(s): Infigratinib
Therapeutic Area: Genetic Disease Product Name: BGJ398
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Undisclosed Upfront Cash: $100.0 million
Deal Type: Licensing Agreement February 07, 2024
Details:
BGJ398 (infigratinib) is an oral small molecule, ATP-competitive, FGFR1-3 tyrosine kinase inhibitor in development for the treatment of FGFR-driven gastric cancer or gastroesophageal junction adenocarcinoma and to target achondroplasia at its source.
Lead Product(s): Infigratinib
Therapeutic Area: Genetic Disease Product Name: BGJ398
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 December 13, 2023
Details:
BGJ398 (infigratinib) is an oral small molecule, ATP-competitive, FGFR1-3 tyrosine kinase inhibitor in development for the treatment of FGFR-driven gastric cancer or gastroesophageal junction adenocarcinoma and to target achondroplasia at its source.
Lead Product(s): Infigratinib
Therapeutic Area: Genetic Disease Product Name: BGJ398
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 September 06, 2023
Details:
Truseltiq (infigratinib) is an oral small molecule, ATP-competitive, FGFR1-3 tyrosine kinase inhibitor in development for the treatment of FGFR-driven gastric cancer or gastroesophageal junction adenocarcinoma and to target achondroplasia at its source.
Lead Product(s): Infigratinib
Therapeutic Area: Oncology Product Name: BGJ398
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: QED Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2023
Details:
Truseltiq (infigratinib) is an oral small molecule, ATP-competitive, FGFR1-3 tyrosine kinase inhibitor in development for the treatment of FGFR-driven cancers and to target achondroplasia at its source.
Lead Product(s): Infigratinib
Therapeutic Area: Genetic Disease Product Name: Truseltiq
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 March 06, 2023
Details:
Truseltiq (infigratinib) was well-tolerated with no SAE and no discontinuations due to AE including in Cohort 5 participants dosed to date, with a median duration of follow-up of 48.1 weeks; only limited number of AEs were assessed as related to study drug and were Grade 1.
Lead Product(s): Infigratinib
Therapeutic Area: Genetic Disease Product Name: Truseltiq
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 July 26, 2022
Details:
Infigratinib (BGJ398), was well-tolerated with no serious adverse events (SAE) and no discontinuations due to adverse events (AE) including in Cohort 5 (dose: 0.25 mg/kg once daily) participants dosed to date, with a median duration of follow-up of 48.1 weeks.
Lead Product(s): Infigratinib
Therapeutic Area: Genetic Disease Product Name: Truseltiq
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 July 26, 2022
Details:
Truseltiq (Infigratinib) is a potent orally administered, selective, ATP‐competitive, kinase inhibitor of FGFRs, with highest affinity for FGFR 1, 2, and 3, is indicated for treatment of adults with previously treated metastatic cholangiocarcinoma with FGFR2 fusion.
Lead Product(s): Infigratinib
Therapeutic Area: Oncology Product Name: Truseltiq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2022
Details:
Helsinn’s renewed focus on developing highly innovative oncology assets to address unmet needs, and this license agreement with Juniper, will ensure that Truseltiq (infigratinib), is accessible to patients in Australia, Southeast Asia and certain markets in Middle East and Africa.
Lead Product(s): Infigratinib
Therapeutic Area: Oncology Product Name: Truseltiq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Juniper Biologics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 04, 2022
Details:
Under the terms of the amended and restated agreement, Helsinn will gain an exclusive license to commercialize infigratinib in the U.S. and will be responsible for developing, manufacturing and commercializing infigratinib in oncology indications worldwide.
Lead Product(s): Infigratinib
Therapeutic Area: Oncology Product Name: Truseltiq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: BridgeBio Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 03, 2022
Details:
Under the terms of the license and distribution agreement, Helsinn Healthcare SA grants Xediton an exclusive license to distribute, promote, market, and sell TRUSELTIQ in Canada and Helsinn will supply TRUSELTIQ for commercialization in Canada.
Lead Product(s): Infigratinib
Therapeutic Area: Oncology Product Name: Truseltiq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Xediton Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 20, 2021
Details:
BridgeBio will retain all rights to infigratinib in skeletal dysplasia, including achondroplasia. Subject to U.S. FDA approval, QED and Helsinn will co-commercialize infigratinib in oncology indications in the U.S. and will share profits and losses on a 50:50 basis.
Lead Product(s): Infigratinib
Therapeutic Area: Oncology Product Name: BGJ398
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: QED Therapeutics
Deal Size: $2,000.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration March 31, 2021
Details:
The U.S. FDA has accepted New Drug Application (NDA) for infigratinib, an oral FGFR1-3 selective inhibitor, for individuals with cholangiocarcinoma, or cancer of the bile ducts. Application accepted under Priority Review designation.
Lead Product(s): Infigratinib
Therapeutic Area: Oncology Product Name: BGJ398
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: QED Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2020
Details:
Precision medicine study designed to confirm infigratinib's ability to cross blood-brain barrier and hit molecular targets in high-grade glioma patients with FGFR genetic alterations.
Lead Product(s): Infigratinib
Therapeutic Area: Oncology Product Name: BBP-831
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ivy Brain Tumor Center
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2020
Details:
First child with achondroplasia has been dosed with the investigational medicine infigratinib, an orally available small molecule, that targets the overactivity of fibroblast growth factor receptor 3 (FGFR3) in the PROPEL 2 Phase 2 clinical trial.
Lead Product(s): Infigratinib
Therapeutic Area: Genetic Disease Product Name: BBP-831
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 July 15, 2020
Details:
Data will be presented reports consistent treatment response in both first-line and later-line treatment settings after Infigratinib (BGJ398) treatment in advanced/unresectable or metastatic urothelial carcinoma.
Lead Product(s): Infigratinib
Therapeutic Area: Oncology 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 May 29, 2020
Details:
The PROOF 302 trial is studying infigratinib for adjuvant treatment of invasive urothelial carcinoma. Second, investigator-initiated trial, is studying infigratinib for the treatment of solid tumors.
Lead Product(s): Infigratinib
Therapeutic Area: Oncology 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 March 12, 2020
Details:
Infigratinib received Fast Track Designation for first-line treatment of adult patients with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or translocations.
Lead Product(s): Infigratinib
Therapeutic Area: Oncology 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 January 06, 2020
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