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    [{"orgOrder":0,"company":"Xenikos B.V","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Xenikos Enrolls First Patient in Global Pivotal Phase 3 Study Evaluating T-Guard\u00ae in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Xenikos B.V"},{"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":"Small molecule","graph2":"Pharming"},{"orgOrder":0,"company":"Alloksys Life Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alloksys Reports Interim Results of Its Clinical Phase IIb Trial with Alkaline Phosphatase Therapy RESCAP\u00ae in Critical Care Patients","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Alloksys Life Sciences"},{"orgOrder":0,"company":"Argenx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Argenx Announces Positive Topline Phase 3 ADAPT Trial Results","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"Argenx","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Argenx Enters Into Agreement To Acquire Priority Review Voucher","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"Zai Lab","pharmaFlowCategory":"D","amount":"$175.0 million","upfrontCash":"$75.0 million","newsHeadline":"Argenx and Zai Lab Announce Strategic Collaboration for Efgartigimod in Greater China","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Argenx Reports Positive Data of Efgartigimod in Myasthenia Gravis Trial","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"argenx Announces Positive Phase 3 Data from ADVANCE Trial of VYVGART\u00ae (efgartigimod alfa-fcab) in Adults with Primary Immune Thrombocytopenia","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"argenx Announces Publication of Translational Data of Efgartigimod in Autoimmune Skin Blistering Diseases","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Argenx Submits Biologics License Application to U.S. Food and Drug Administration for Subcutaneous Efgartigimod for Treatment of Generalized Myasthenia Gravis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"USFDA","pharmaFlowCategory":"D","amount":"$102.0 million","upfrontCash":"Undisclosed","newsHeadline":"argenx Enters Into Agreement To Acquire Priority Review Voucher","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"argenx Announces U.S. FDA Acceptance of Biologics License Application for Subcutaneous Efgartigimod in Generalized Myasthenia Gravis with Priority Review","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"argenx to Present Pivotal ADVANCE Trial Data During ASH Plenary Session Highlighting VYVGART\u00ae (efgartigimod alfa-fcab) as Potential New Treatment Modality for Immune Thrombocytopenia","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Argenx Receives Notification of PDUFA Date Extension for SC Efgartigimod","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"argenx Reports Topline Results from ADDRESS Study of Efgartigimod SC in Pemphigus","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"},{"orgOrder":0,"company":"Argenx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"argenx Reports Topline Results from ADVANCE-SC Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Argenx"}]

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              Argenx

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              argenx Reports Topline Results from ADDRESS Study of Efgartigimod SC in Pemphigus

              Details:

              Efgartigimod SC (efgartigimod alfa and hyaluronidase-qvfc) subcutaneous injection is being evaluated in phase 3 clinical trials for the treatment of pemphigus vulgaris (PV) and pemphigus foliaceus (PF).

              Lead Product(s): Efgartigimod Alfa,Hyaluronidase

              Therapeutic Area: Immunology Product Name: Efgartigimod SC

              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 December 19, 2023

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              Argenx

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              argenx Reports Topline Results from ADVANCE-SC Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia

              Details:

              VYVGART Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20, Halozyme’s ENHANZE® drug delivery technolog, is being developed for in adults with primary immune thrombocytopenia (ITP).

              Lead Product(s): Efgartigimod Alfa,Hyaluronidase

              Therapeutic Area: Immunology Product Name: Vyvgart Hytrulo

              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 November 28, 2023

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              Alloksys Life Sciences

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              Alloksys Reports Interim Results of Its Clinical Phase IIb Trial with Alkaline Phosphatase Therapy RESCAP® in Critical Care Patients

              Details:

              Rescap® (RESCuing Alkaline Phosphatase), is a proprietary medication developed by Alloksys, based on the enzyme alkaline phosphatase (AP). RESCAP® is derived from calf intestines and has been demonstrated to be safe and suitable for intravenous administration in humans.

              Lead Product(s): Alkaline Phosphatase

              Therapeutic Area: Immunology Product Name: Rescap

              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 24, 2023

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              Argenx

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              Argenx Receives Notification of PDUFA Date Extension for SC Efgartigimod

              Details:

              Vyvgart (efgartigimod) is an antibody fragment designed to reduce pathogenic IgG antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling process. It is indicated for several autoimmune diseases known to be mediated by disease-causing IgG antibodies.

              Lead Product(s): Efgartigimod

              Therapeutic Area: Immunology Product Name: Vyvgart

              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 January 31, 2023

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              Argenx

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              argenx to Present Pivotal ADVANCE Trial Data During ASH Plenary Session Highlighting VYVGART® (efgartigimod alfa-fcab) as Potential New Treatment Modality for Immune Throm...

              Details:

              VYVGART is used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).

              Lead Product(s): Efgartigimod

              Therapeutic Area: Immunology Product Name: Vyvgart

              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 December 10, 2022

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              Argenx

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              argenx Enters Into Agreement To Acquire Priority Review Voucher

              Details:

              Efgartigimod is an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling process.

              Lead Product(s): Efgartigimod

              Therapeutic Area: Immunology Product Name: Vyvgart

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: USFDA

              Deal Size: $102.0 million Upfront Cash: Undisclosed

              Deal Type: Acquisition November 29, 2022

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              Argenx

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              argenx Announces U.S. FDA Acceptance of Biologics License Application for Subcutaneous Efgartigimod in Generalized Myasthenia Gravis with Priority Review

              Details:

              SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology. ENHANZE facilitates the SC injection delivery of biologics that are typically administered via IV infusion.

              Lead Product(s): Efgartigimod

              Therapeutic Area: Immunology Product Name: Vyvgart

              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 November 22, 2022

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              Pharming

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              Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for Leniolisib Pharming Group N.V. Logo

              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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              Argenx

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              Argenx Submits Biologics License Application to U.S. Food and Drug Administration for Subcutaneous Efgartigimod for Treatment of Generalized Myasthenia Gravis

              Details:

              SC efgartigimod (vyvgart) is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology. ENHANZE facilitates the subcutaneous injection delivery of biologics that are typically administered via intravenous (IV) infusion.

              Lead Product(s): Efgartigimod

              Therapeutic Area: Immunology Product Name: Vyvgart

              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 September 21, 2022

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              Xenikos B.V

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              Xenikos Enrolls First Patient in Global Pivotal Phase 3 Study Evaluating T-Guard® in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease

              Details:

              T-Guard (ricin toxin A conjugated mAB) is designed to safely and swiftly reset the body’s immune system in life-threatening T cell‒mediated conditions, including transplant-related rejection, acute solid-organ rejection, and severe autoimmune disease.

              Lead Product(s): Ricin Toxin A Conjugated Monoclonal Antibodies

              Therapeutic Area: Immunology Product Name: T-Guard

              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 June 27, 2022

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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