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[{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Clinical Study Data for Gilead\u2019s Investigational HIV-1 Capsid Inhibitor GS-6207 Presented at CROI 2020","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead Sciences Demonstrates Commitment to Scientific Innovation In HIV With New Prevention","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead Sciences Presents Data From HIV Research and Development Programs at HIV Glasgow 2020","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead Announces Positive Results from Phase 2\/3 CAPELLA Trial of Lenacapavir in Heavily Treatment-Experienced People Living with HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead to Present New Data at CROI 2021 Demonstrating the Company's Commitment to Addressing Urgent Global Health Needs","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead\u2019s Investigational Lenacapavir Demonstrates Sustained Long-Acting Efficacy Through Week 26 in Data Presented at CROI","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead Submits New Drug Application to U.S. FDA for Lenacapavir","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EMA Validates Gilead\u2019s Marketing Authorization Application for Lenacapavir","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Merck & Co","sponsor":"Gilead Sciences","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead and Merck Initiate Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Lenacapavir and Investigational Islatravir for HIV-1 Treatment in Virologically Suppressed Adults","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Merck & Co","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead and Merck Announce Temporary Pause in Enrollment for Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Islatravir and Investigational Lenacapavir","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead Announces Clinical Hold on Studies Evaluating Injectable Lenacapavir for HIV Treatment and Prevention Due to Vial Quality Concerns","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Clinical Data Support the Sustained Efficacy of Long-acting Lenacapavir, Gilead\u2019s Investigational HIV-1 Capsid Inhibitor","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase 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Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Investigational Lenacapavir Receives Positive CHMP Opinion for People With Multi-Drug Resistant HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead Announces First Global Regulatory Approval of Sunlenca\u00ae (lenacapavir), the Only Twice-Yearly HIV Treatment Option","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves New HIV Drug for Adults with Limited Treatment Options","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sunlenca\u00ae (lenacapavir) Receives FDA Approval as a First-in-Class, Twice-Yearly Treatment Option for People Living With Multi-Drug Resistant HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead Presents Positive Proof-of-Concept Data for Investigational Combination Regimen of Lenacapavir with Broadly Neutralizing Antibodies as a Potential Twice-Yearly Approach for the Treatment of HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead Sciences Announces New Clinical Trial in Europe to Assess Lenacapavir for HIV Prevention as Part of Landmark Purpose Program","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead\u2019s Innovative HIV Treatment Research Pipeline Aims to Address Unmet Needs and Advance Public Health","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Merck & Co","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"}]

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            Details:

            MK-8591 (islatravir) is a non-nucleoside reverse transcriptase translocation inhibitor, which is being investigated in phase 2 for HIV-1 infection, in combination with lenacapavir.

            Lead Product(s): Islatravir,Lenacapavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Merck & Co

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 06, 2024

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            GS-9883 (bictegravir), an HIV type 1 integrase inhibitor in combination with GS-6207 (lenacapavir), a structural capsid protein inhibitor is being evaluated for the treatment of HIV-1-infection.

            Lead Product(s): Bictegravir,Lenacapavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: GS-9883

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 05, 2024

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            Sunlenca (lenacapavir) is a selective long-acting inhibitor of HIV-1 capsid function which inhibits HIV-1 replication by interfering with multiple essential steps of the viral lifecycle.

            Lead Product(s): Lenacapavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 18, 2023

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            Sunlenca (lenacapavir) is a selective long-acting inhibitor of HIV-1 capsid function which inhibits HIV-1 replication by interfering with multiple essential steps of the viral lifecycle.

            Lead Product(s): Lenacapavir,Teropavimab,Zinlirvimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 22, 2023

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            Sunlenca is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1. Sunlenca works by blocking the HIV-1 virus’ protein shell (the capsid), thereby interfering with multiple essential steps of the viral lifecycle.

            Lead Product(s): Lenacapavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 22, 2022

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            Sunlenca (lenacapavir) is a first-in-class, long-acting HIV capsid inhibitor approved in the United States, the United Kingdom, Canada and the European Union, for the treatment of HIV infection, in combination with other antiretroviral.

            Lead Product(s): Lenacapavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 22, 2022

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            Sunlenca (lenacapavir), is first-in-class capsid inhibitor with multi-stage mechanism of action, offering a new, every six-month treatment option for people with HIV whose virus no longer effectively responds to their current therapy.

            Lead Product(s): Lenacapavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 22, 2022

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            The NDA resubmission contains comprehensive CMC data to support the compatibility of GS-6207 (lenacapavir), first-in-class, investigational long-acting HIV-1 capsid inhibitor with an alternative vial type made from aluminosilicate glass.

            Lead Product(s): Lenacapavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 27, 2022

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            Recommendation is based on week 26 Data from the CAPELLA Trial showing twice-yearly GS-6207 (lenacapavir) achieved high rates of virologic suppression in heavily treatment-experienced people with HIV.

            Lead Product(s): Lenacapavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca

            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 24, 2022

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            Details:

            GS-6207 (Lenacapavir) is Gilead’s potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. Lenacapavir was generally well tolerated in CAPELLA, with no serious adverse events.

            Lead Product(s): Lenacapavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207

            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 16, 2022

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