Welcome to our dedicated page for Argenx Se news (Ticker: ARGX), a resource for investors and traders seeking the latest updates and insights on Argenx Se stock.
argenx SE (ARGX) is a global immunology company listed on Euronext and Nasdaq that focuses on severe autoimmune diseases through antibody-based medicines. Its news flow centers on clinical data, regulatory milestones, commercial performance and strategic updates related to its FcRn-targeting medicine VYVGART and a broader pipeline of experimental antibodies.
Investors and healthcare observers following ARGX news can read about regulatory interactions such as the U.S. Food and Drug Administration’s acceptance for priority review of a supplemental Biologics License Application (sBLA) for VYVGART in acetylcholine receptor antibody seronegative generalized myasthenia gravis (gMG). Company announcements also cover Phase 3 trial readouts, including the ADAPT SERON study in seronegative gMG and other registrational programs across neuromuscular and autoimmune indications.
argenx regularly reports preliminary and quarterly financial results, highlighting global product net sales from the VYVGART franchise and outlining strategic priorities tied to its long-term "Vision 2030". News items describe the expansion of VYVGART and VYVGART Hytrulo across gMG, chronic inflammatory demyelinating polyneuropathy (CIDP) and immune thrombocytopenia (ITP) in certain regions, as well as progress with pipeline candidates such as empasiprubart and ARGX-119.
Corporate news includes leadership transitions, conference presentations at major medical and investor meetings, and updates from the company’s Immunology Innovation Program (IIP). For readers interested in ARGX stock and the evolution of its immunology franchise, this news feed provides a consolidated view of clinical, regulatory, commercial and corporate developments as disclosed in argenx press releases and related filings.
argenx has announced the global commercial launch of VYVGART™ for the treatment of generalized myasthenia gravis. The company expects to report data from five registrational trials of efgartigimod by Q1 2023 and plans to initiate trials in four new indications, including lupus nephritis and Sjogren’s syndrome, in 2022. With approximately $2.3 billion in cash as of December 31, 2021, argenx anticipates a busy 2022, focusing on expanding its efgartigimod portfolio and maintaining its leadership in FcRn blockade.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, announced that CEO Tim Van Hauwermeiren will present at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 7:30 a.m. ET. A live webcast will be available in the Investors section of the argenx website. The company is focused on severe autoimmune diseases and is commercializing VYVGART (efgartigimod alfa-fcab), the first FDA-approved neonatal Fc receptor blocker for generalized myasthenia gravis in adult patients. For more details, visit argenx.com.
argenx SE (Euronext & Nasdaq: ARGX) announced FDA approval for VYVGART™ (efgartigimod alfa-fcab) as the first and only FDA-approved neonatal Fc receptor blocker, targeting generalized myasthenia gravis (gMG) in anti-acetylcholine receptor (AChR) antibody-positive adult patients. In the Phase 3 ADAPT trial, 68% of treated patients were responders on the MG-ADL scale, compared to 30% for placebo (p0.0001). The company has also secured value-based agreements with several payers and plans to support patient access through its My VYVGART Path program.
On November 10, 2021, argenx announced its participation in several key healthcare conferences aimed at discussing advancements in immunology. The events include:
- Guggenheim Healthcare Talks on November 15, 2021
- Evercore ISI HealthCONx Conference on November 30, 2021
- Piper Sandler Healthcare Conference, with a pre-recorded chat available on November 22, 2021
Details about these conferences can be found on the Investors section of the argenx website.
argenx (ARGX) announced its third-quarter 2021 financial results, highlighting the build-up of its commercial teams in the U.S. and Japan in preparation for the potential launch of efgartigimod for generalized myasthenia gravis (gMG). The company signed a partnership with Medison for the distribution of efgartigimod in Israel and is pursuing innovative collaborations in key markets. Financially, total operating income rose to $494.6 million due to significant collaboration revenue, while operating losses amounted to $117.8 million. Cash resources increased to $2.53 billion, attributed to a recent global offering.
argenx (ARGX), a global immunology company, will hold a conference call on October 28, 2021, at 2:30 PM CET to discuss its Q3 2021 financial results and offer a business update. The call will be accessible via the Investors section of their website, and a replay will be available for a year. argenx is focused on developing innovative antibody-based therapies for severe autoimmune diseases and cancer, actively evaluating its lead product efgartigimod.
argenx (ARGX) announced additional data from the Phase 3 ADAPT trial of efgartigimod for generalized myasthenia gravis (gMG). Key highlights include consistent depth of response and improvements in disease scores across patient subgroups. Notably, efgartigimod treatment does not impact vaccine immune responses. Initial findings from the MyRealWorld® MG research study shed light on the disease's severity and treatment burden on patients. The data will be showcased at upcoming neuromuscular conferences, enhancing the understanding of efgartigimod's potential benefits.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, has announced its participation in several upcoming conferences focused on healthcare and biotechnology. Key events include the KBC Life Sciences & Biotech Virtual Conference on September 7, the Morgan Stanley Global Healthcare Conference on September 10, the BofA Global Healthcare Conference on September 16, and the SVB Leerink CybeRx Series event on September 22. Further details can be found on the Investors section of argenx's website.
argenx announced the validation of its marketing authorization application (MAA) for efgartigimod as a treatment for generalized myasthenia gravis (gMG) by the European Medicines Agency (EMA). This marks a significant step in the regulatory process, which began on August 19, 2021, with a decision expected by mid-2022. If approved, efgartigimod will be the first FcRn antagonist in Europe. The application is supported by positive results from the Phase 3 ADAPT trial involving 167 patients across North America, Europe, and Japan. The FDA and Japanese authorities are also reviewing the drug.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, announced its participation in a fireside chat at the 2021 Wedbush PacGrow Virtual Healthcare Conference on August 11, 2021, at 11:30 a.m. ET. A live webcast will be available on the argenx website, with a replay accessible for 90 days post-event. The company is dedicated to developing novel antibody-based treatments for serious autoimmune diseases and cancer.