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[{"orgOrder":0,"company":"Pharming","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Receives Orphan Drug Designation from EC for Leniolisib for the Treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Pharming"},{"orgOrder":0,"company":"Pharming","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Announces Positive Data from Phase II\/III Leniolisib Trial Presented at Clinical Immunology Society 2022 Annual Meeting","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Pharming"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Receives Agreement of Paediatric Investigation Plan and Promising Innovative Medicine Designation for leniolisib from UK MHRA","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Pharming"}]

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            An agreed paediatric investigation plan is regulatory pathway to market authorization for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor as a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) in children.

            Lead Product(s): Leniolisib

            Therapeutic Area: Immunology Product Name: CDZ173

            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 April 26, 2022

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            In index lymphadenopathy lesions, a statistically significant adjusted mean change in log10 transformed sum of product of diameters (SPD) of -0.30 among patients who received leniolisib, inhibit the production of PIP3, compared with -0.06 among patients who received placebo.

            Lead Product(s): Leniolisib

            Therapeutic Area: Immunology Product Name: CDZ173

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

            Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 01, 2022

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            Leniolisib is a small molecule phosphoinositide 3-kinase delta (PI3Kẟ) inhibitor with immunomodulating and potentially anti-neoplastic activities. Leniolisib inhibits the production of phosphatidylinositol-3-4-5-trisphosphate (PIP3).

            Lead Product(s): Leniolisib

            Therapeutic Area: Immunology Product Name: CDZ173

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

            Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 21, 2020

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