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[{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pfizer Announces Positive Top-Line Results from Phase 3 Study of Hemophilia B Gene Therapy Candidate","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Pfizer\u2019s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Health Canada Approves Pfizer Canada's Gene Therapy in Hemophilia B","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Approves Pfizer\u2019s BEQVEZ\u2122 (fidanacogene elaparvovec-dzkt), a One-Time Gene Therapy for Adults with Hemophilia B","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Labcorp","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Labcorp Receives FDA Approval for First Companion Diagnostic for Use with Pfizer's Newly Approved Gene Therapy to Treat Patients with Hemophilia B","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"}]

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            FDA has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer's recently FDA-approved hemophilia B gene therapy.

            Lead Product(s): Fidanacogene elaparvovec

            Therapeutic Area: Genetic Disease Product Name: Beqvez

            Highest Development Status: Approved Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 29, 2024

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            Beqvez (fidanacogene elaparvovec) is an adeno-associated virus (AAV)-based gene therapy designed to introduce in the transduced cells a functional copy of the FIX gene encoding a high-activity FIX variant. It is approved for the treatment of adults with moderate to severe hemophilia B.

            Lead Product(s): Fidanacogene elaparvovec

            Therapeutic Area: Genetic Disease Product Name: Beqvez

            Highest Development Status: Approved Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 26, 2024

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            BEQVEZ (fidanacogene elaparvovec) is an adeno-associated viral (AAV) vector-based gene therapy approved for the treatment of adults with moderately severe to severe hemophilia B.

            Lead Product(s): Fidanacogene elaparvovec

            Therapeutic Area: Genetic Disease Product Name: Beqvez

            Highest Development Status: Approved Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 03, 2024

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            PF-06838435 (fidanacogene elaparvovec) is a novel, investigational gene therapy that contains a bio-engineered AAV capsid and a high-activity variant of human coagulation FIX gene. Currently it is being investigated for Hemophilia B.

            Lead Product(s): Fidanacogene elaparvovec

            Therapeutic Area: Genetic Disease Product Name: PF-06838435

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 27, 2023

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            Details:

            PF-06838435 (fidanacogene elaparvovec), is a novel, investigational vector that contains a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity human coagulation FIX gene.

            Lead Product(s): Fidanacogene elaparvovec

            Therapeutic Area: Genetic Disease Product Name: PF-06838435

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 29, 2022

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