Renejix CDMO Partner for Small Molecule Oral Dosage Forms Renejix CDMO Partner for Small Molecule Oral Dosage Forms

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[{"orgOrder":0,"company":"Agios Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Agios to Present Updated Data from the Phase 1 Study of Vorasidenib in Non-enhancing Glioma at the ASCO Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Agios Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Agios Presents Updated Data from the Phase 1 Dose-escalation Study of Vorasidenib in Patients with IDH-mutant Non-enhancing Glioma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Agios Pharmaceuticals","sponsor":"Servier","pharmaFlowCategory":"D","amount":"$2,000.0 million","upfrontCash":"$1,800.0 million","newsHeadline":"Servier to Acquire Agios Pharmaceuticals\u2019 Oncology Business","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Servier","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Servier Presents Updated Translational Data from Perioperative Study of Vorasidenib and TIBSOVO in Patients with IDH Mutant Low-Grade Glioma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Agios Pharmaceuticals","sponsor":"Royalty Pharma","pharmaFlowCategory":"D","amount":"$905.0 million","upfrontCash":"$905.0 million","newsHeadline":"Agios Announces $905 Million Purchase Agreement for Vorasidenib Royalty","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Servier","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Servier's Pivotal Phase 3 INDIGO Trial Investigating Vorasidenib in IDH-Mutant Low-Grade Glioma Meets Primary Endpoint of Progression-Free Survival (PFS) and Key Secondary Endpoint of Time to Next Intervention (TTNI)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Servier","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Analyses from Pivotal Phase 3 INDIGO Study Reinforce Vorasidenib's Potential to Change the Treatment Paradigm for IDH-Mutant Diffuse Glioma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Servier","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA and EMA Accept Vorasidenib Regulatory Submissions for the Treatment of IDH-Mutant Diffuse Glioma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]

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            Royalty Pharma gain rights for AG-881 (vorasidenib), an oral, selective, highly brain-penetrant dual inhibitor of mutant IDH1/2 enzymes for the treatment of IDH-mutant diffuse glioma.

            Lead Product(s): Vorasidenib

            Therapeutic Area: Oncology Product Name: AG-881

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Royalty Pharma

            Deal Size: $905.0 million Upfront Cash: $905.0 million

            Deal Type: Agreement May 28, 2024

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            AG-881 (vorasidenib) is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes. It is being evaluated for the treatment of IDH-mutant diffuse glioma.

            Lead Product(s): Vorasidenib

            Therapeutic Area: Oncology Product Name: AG-881

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 20, 2024

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            AG-881 (vorasidenib) is an oral, brain-penetrant, dual inhibitor of mutant (m)IDH1/2 enzymes. It is being evaluated for the treatment of IDH-Mutant Diffuse Glioma.

            Lead Product(s): Vorasidenib

            Therapeutic Area: Oncology Product Name: AG-881

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 18, 2023

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            AG-881 (vorasidenib) is a first-in-class, brain-penetrant, dual inhibitor of the mutant IDH1 and mutant IDH2 enzymes. It is beinf developed for the treament of IDH-mutant low-grade glioma.

            Lead Product(s): Vorasidenib

            Therapeutic Area: Oncology Product Name: AG-881

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 14, 2023

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            Data from the ongoing perioperative study found that treatment with vorasidenib 50mg and TIBSOVO 500mg resulted in mean percent reduction in 2-HG (95% CI) of 92.6% (76.1, 97.6) and 91.1% (72, 97) respectively, relative to untreated samples in patients with low-grade glioma.

            Lead Product(s): Vorasidenib

            Therapeutic Area: Oncology Product Name: AG-881

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 07, 2021

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            Details:

            In-line with Servier’s strategy, this acquisition will enable the Group to strengthen its product portfolio and drug development pipeline in oncology. Includes Agios’ marketed medicine TIBSOVO® and a strong oncology pipeline of Phase 3 and early-stage assets.

            Lead Product(s): Vorasidenib

            Therapeutic Area: Oncology Product Name: AG-881

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Servier

            Deal Size: $2,000.0 million Upfront Cash: $1,800.0 million

            Deal Type: Acquisition December 21, 2020

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            Vorasidenib demonstrated prolonged disease control and encouraging preliminary activity with median progression-free survival of 31.4 months.

            Lead Product(s): Vorasidenib

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 29, 2020

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            Vorasidenib and ivosidenib clinical data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.

            Lead Product(s): Vorasidenib

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 13, 2020

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