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Details:
Vyvgart Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, & recombinant human hyaluronidase PH20 (rHuPH20). It is being evaluated for the treatment of chronic inflammatory demyelinating polyneuropathy.
Lead Product(s): Efgartigimod,rHuPH20
Therapeutic Area: Neurology Product Name: Vyvgart Hytrulo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 20, 2024
Details:
Vyvgart (efgartigimod alfa-fcab) is a human IgG1 antibody fragment formulated with recombinant human hyaluronidase PH20 (rHuPH20). It is approved for the treatment of for generalized myasthenia gravis.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2023
Details:
Vyvgart (efgartigimod alfa and hyaluronidase-qvfc) injection is formulated with ENHANZE for subcutaneous (SC) use for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2023
Details:
The net proceeds will be used to accelerate company's commercial investment to propel Vyvgart (efgartigimod alfa fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) as a leading therapy globally.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: J.P. Morgan
Deal Size: $750.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 17, 2023
Details:
VYVGART (efgartigimod alfa and hyaluronidase-qvfc) injection with ENHANZE for subcutaneous (SC) use for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2023
Details:
Vyvgart (efgartigimod alfa-fcab) 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 treating generalized myasthenia gravis.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2023
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2023
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2022
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: USFDA
Deal Size: $102.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition November 29, 2022
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2022
Details:
Under the agreement, FUJIFILM Diosynth Biotechnologies will provide drug substance manufacturing of efgartigimod (Vyvgart) at its large-scale biomanufacturing facility in Hillerod, Denmark.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Argenx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 27, 2022
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2022
Details:
68% of anti-AChR antibody positive gMG patients treated with VYVGART (efgartigimod alfa-fcab) were responders on MG-ADL scale compared with 30% of patients treated with placebo during the first treatment cycle in the Phase 3 ADAPT trial.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2022
Details:
Positive opinion based on Phase 3 ADAPT trial showing Vyvgart (efgartigimod), an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies provided clinically meaningful improvements in strength and quality of life measures.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2022
Details:
Efgartigimod is approved in the United States as VYVGART® for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Medison Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 06, 2022
Details:
Translational data from Phase 2 study of Vyvgart (efgartigimod) in pemphigus further demonstrate argenx’s scientific leadership in FcRn biology, providing new insights into pathophysiology of autoimmune skin blistering diseases and potential role of FcRn blockade.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2022
Details:
Study met primary endpoint, demonstrating a higher proportion of sustained platelet response with VYVGART (efgartigimod alfa-fcab) treatment compared to placebo (p=0.0316); responders observed across patient types regardless of prior therapy or disease severity.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
Interim data suggest long-term treatment with VYVGART (efgartigimod alfa-fcab), provides improvement in generalized myasthenia gravis (gMG) disease scores that remains consistent over multiple treatment cycles.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2022
Details:
ADAPT+ is the global Phase 3 open-label extension study evaluating long-term efficacy, safety and tolerability of VYVGART® (efgartigimod alfa-fcab) in adult patients with generalized myasthenia gravis (gMG).
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
Study met primary endpoint, demonstrating noninferior total IgG reduction at day 29 with subcutaneously administered Vyvgart (efgartigimod alfa-fcab) compared to intravenous (IV) administration.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Halozyme Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Details:
Soleo Health offers differentiated capabilities through its ability to collect real-world data and generate intelligent outcomes from VYVGART patients with its exclusive and proprietary clinical outcomes program, SoleMetrics®.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Argenx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 24, 2022
Details:
The approval of VYVGART (efgartigimod alfa-fcab) for the treatment of gMG is based on results from the global Phase 3 ADAPT trial. The ADAPT trial met its primary endpoint with 68% anti-AChR antibody positive gMG patients responders on the MG-ADL scale.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2021
Details:
Phase 3 ADAPT trial of efgartigimod, an FcRn antagonist, for the treatment of adults living with generalized myasthenia gravis (gMG). Efgartigimod is currently under review with the FDA for the treatment of gMG.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: ARGX-113
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2021
Details:
Under the terms of this collaboration and license agreement, Argenx and Elektrofi will explore new subcutaneous formulations for therapeutic products directed at the human neonatal Fc receptor (FcRn), including efgartigimod, and up to one additional target.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: ARGX-113
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Argenx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 20, 2021
Details:
The preclinical research collaboration is set up to explore the potential of combining imlifidase, Hansa’s IgG antibody-cleaving enzyme, and efgartigimod, argenx’s FcRn antagonist, which are both in development for indications known to be driven by disease-causing IgGs.
Lead Product(s): Imlifidase,Efgartigimod
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Argenx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 29, 2021
Details:
Collaboration to expand and accelerate global development of efgartigimod; expected to allow argenx to more rapidly advance new potential indications into clinical development each year.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: ARGX-113
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Zai Lab
Deal Size: $175.0 million Upfront Cash: $75.0 million
Deal Type: Collaboration January 06, 2021
Details:
Argenx has agreed to acquire a U.S. Food and Drug Administration (FDA) Priority Review Voucher (PRV) from Bayer Healthcare Pharmaceuticals. argenx expects to redeem the PRV for a future marketing application for its FcRn antagonist efgartigimod.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: ARGX-113
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Argenx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 23, 2020
Details:
Under the newly announced expansion, argenx gained the ability to exclusively access Halozyme's ENHANZE® drug delivery technology for three additional targets upon nomination for a total of up to six targets under the existing and newly expanded collaboration.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: ARGX-113
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Argenx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 06, 2020
Details:
ADAPT met its primary endpoint defined as percentage of responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score among acetylcholine receptor-antibody positive (AChR-Ab+) generalized myasthenia gravis (gMG) patients.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2020
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