Athena Athena

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[{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Reports Encouraging Results from Use of RUCONEST\u00ae in COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Announces Enrolment of First Patient in Multinational Clinical Trial for the Treatment of COVID-19 with RUCONEST\u00ae","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"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":"Immunology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Pharming","sponsor":"Orchard Therapeutics","pharmaFlowCategory":"D","amount":"$211.5 million","upfrontCash":"$17.5 million","newsHeadline":"Orchard Therapeutics and Pharming Group Collaborate to Develop and Commercialize Ex Vivo Autologous HSC Gene Therapy for Genetic Angioedema","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"NETHERLANDS","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"},{"orgOrder":0,"company":"Pharming","sponsor":"NewBridge Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Pharming Signs Agreement with NewBridge for the Commercialization of RUCONEST","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"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":"Immunology","graph2":"Phase II\/ Phase III"},{"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":"Immunology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Group Receives Accelerated Assessment in Europe for leniolisib for the Treatment of Rare Immunodeficiency, APDS","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for Leniolisib \nPharming Group N.V. Logo","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Group Announces Presentation Of New Leniolisib Data At 2022 ASH Annual Meeting","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Announces Publication Of Data From Phase 3 Study Of Leniolisib In Patients With APDS in ASH's Blood","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Announces Positive Interim Analysis Data from Open-Label Extension Study of Leniolisib in Presentation at The 64th American Society of Hematology (ASH) Annual Meeting and Exposition English","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Provides Update on EMA Regulatory Review of Leniolisib For APDS in Europe","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Announces First Patient Enrolled in Pediatric Clinical Trial of Leniolisib","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Announces US FDA Approval of Joenja\u00ae (leniolisib) as The First and Only Treatment Indicated for APDS","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"NETHERLANDS","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Pharming","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"D","amount":"$21.1 million","upfrontCash":"Undisclosed","newsHeadline":"Pharming Announces Sale of Priority Review Voucher","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"NETHERLANDS","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Announces First Patient Enrolled in Phase III Clinical Trial of Leniolisib for the Treatment of APDS in Japan","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Pharming","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharming Group Provides Updates on EMA Regulatory Review of Leniolisib MAA and Plans to File For UK Regulatory Approval","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"}]

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            Details:

            Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with APDS.

            Lead Product(s): Leniolisib

            Therapeutic Area: Rare Diseases and Disorders Product Name: Joenja

            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 10, 2023

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            Details:

            Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with APDS.

            Lead Product(s): Leniolisib

            Therapeutic Area: Rare Diseases and Disorders Product Name: Joenja

            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 August 09, 2023

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            Under the agreement, Pharming will sell its Rare Pediatric Disease Priority Review Voucher, in connection with the approval of Joenja® (leniolisib), an oral, selective PI3Kδ inhibitor, for activated PI3Kδ syndrome, a rare and progressive primary immunodeficiency, to Novartis.

            Lead Product(s): Leniolisib

            Therapeutic Area: Rare Diseases and Disorders Product Name: Joenja

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

            Deal Size: $21.1 million Upfront Cash: Undisclosed

            Deal Type: Divestment June 01, 2023

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            Details:

            Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with APDS.

            Lead Product(s): Leniolisib

            Therapeutic Area: Rare Diseases and Disorders Product Name: Joenja

            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 March 24, 2023

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            Leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor. It is being investigated in children with activated phosphoinositide 3-kinase delta syndrome (APDS).

            Lead Product(s): Leniolisib

            Therapeutic Area: Genetic Disease 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 February 21, 2023

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            Details:

            Leniolisib is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K. PI3K delta is a valid and potentially effective therapeutic target for immune diseases such as APDS.

            Lead Product(s): Leniolisib

            Therapeutic Area: Rare Diseases and Disorders Product Name: CDZ173

            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 16, 2023

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            CDZ173 (leniolisib), an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, to treat adult and adolescent patients with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency.

            Lead Product(s): Leniolisib

            Therapeutic Area: Rare Diseases and Disorders Product Name: CDZ173

            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 December 15, 2022

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            Details:

            Leniolisib is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K. To date, leniolisib has been well tolerated during both the Phase 1 trial in healthy subjects and Phase II/III registration-enabling study in patients with APDS.

            Lead Product(s): Leniolisib

            Therapeutic Area: Rare Diseases and Disorders Product Name: CDZ173

            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 December 06, 2022

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            Details:

            Leniolisib is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K. PI3Kδ is expressed predominately in hematopoietic cells and is essential to normal immune system function.

            Lead Product(s): Leniolisib

            Therapeutic Area: Rare Diseases and Disorders Product Name: CDZ173

            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 23, 2022

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            Details:

            CDZ173 (leniolisib) is small-molecule inhibitor of delta isoform of the 110 kDa catalytic subunit of class IA PI3K. PI3Kδ is expressed predominately in hematopoietic cells and is essential to normal immune system function through conversion of PIP2 to PIP3.

            Lead Product(s): Leniolisib

            Therapeutic Area: Immunology Product Name: CDZ173

            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 October 28, 2022

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