CSBio CSBio

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[{"orgOrder":0,"company":"CSL","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CSL Announces Positive Top-Line Phase 3 Results for Garadacimab as Preventive Treatment in Patients with Hereditary Angioedema (HAE)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"CSL"},{"orgOrder":0,"company":"CSL","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CSL\u2019s Novel Gene Therapy HEMGENIX\u00ae (etranacogene dezaparvovec-drlb) Demonstrates Durable Protection and Sustained Factor IX Activity Levels for People Living with Hemophilia B at 24-Months Post-Treatment","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"CSL"},{"orgOrder":0,"company":"CSL","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CSL's Phase 3 Study Shows First-In-Class Garadacimab Provides Patients with Significant HAE Attack Prevention with Monthly Dosing","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"CSL"}]

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            CSL

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            • Development Update

            Details:

            CSL312 (garadacimab) is a novel Factor XIIa-inhibitory mAb (FXIIa), which uniquely inhibits the plasma protein, FXIIa, by which inhibits the hereditary angioedema (HAE).

            Lead Product(s): Garadacimab

            Therapeutic Area: Genetic Disease Product Name: CSL312

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 26, 2023

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            CSL

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            • Development Update

            Details:

            HEMGENIX (Etranacogene Dezaparvovec-drlb), is the first and only one-time gene therapy approved for the treatment of adults living with hemophilia B. HEMGENIX is approved for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy.

            Lead Product(s): Etranacogene Dezaparvovec-drlb

            Therapeutic Area: Genetic Disease Product Name: Hemgenix

            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 10, 2022

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            CSL

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            • Development Update

            Details:

            CSL312 (garadacimab) is novel Factor XIIa-inhibitory monoclonal antibody (FXIIa mAb) currently in Phase 3 clinical development as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema.

            Lead Product(s): Garadacimab

            Therapeutic Area: Genetic Disease Product Name: CSL312

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 17, 2022

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