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 reports developments as a global immunology company developing and commercializing antibody-based medicines for severe autoimmune diseases. Its updates center on VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), including approved use in adult generalized myasthenia gravis and clinical and regulatory work across myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
Recurring announcements also cover product sales, business updates, presentations of neuromuscular data, and pipeline progress for candidates such as empasiprubart, a monoclonal antibody targeting complement factor C2, and adimanebart. Governance items include annual general meeting results, board appointments, and leadership transitions for the Euronext- and Nasdaq-listed foreign issuer.
argenx SE (Euronext & Nasdaq: ARGX) announced positive topline results from the Phase 3 ADAPT-SC study, showing that subcutaneous efgartigimod achieved noninferior total IgG reduction in generalized myasthenia gravis patients compared to intravenous administration. The study met its primary endpoint with a 66.4% IgG reduction at day 29, versus 62.2% for VYVGART. The company plans to submit a Biologics License Application (BLA) to the FDA by the end of 2022, aiming to enhance treatment options for patients and address the need for individualized care.
argenx reported a transformational year in 2021, highlighted by the FDA approval and U.S. launch of VYVGART, the first FcRn blocker for generalized myasthenia gravis. Full-year revenue soared to $497.3 million, a substantial increase from $41.2 million in 2020, primarily due to collaboration agreements. However, operating losses decreased to $348.7 million from $477.6 million the previous year. The company anticipates utilizing up to half of its cash reserves in 2022 to support the global launch of VYVGART and expand its pipeline with new indications.
February 28, 2022 – argenx (Euronext & Nasdaq: ARGX) announced its participation in the 42nd Annual Cowen Health Care Conference on March 7, 2022, at 2:10 p.m. E.T. Management will engage in a fireside chat during the event. Interested parties can access a live webcast via the Investors section of the argenx website, with a replay available for 90 days after the presentation. argenx specializes in creating innovative therapies for severe autoimmune diseases.
argenx (Euronext & Nasdaq: ARGX) announced a conference call on March 3, 2022, at 2:30 pm CET (8:30 am ET) to discuss its full year 2021 financial results and provide a fourth quarter business update. The call will be accessible via the Investors section on the company's website. A replay will be available for a year after the call. argenx focuses on developing innovative treatments for severe autoimmune diseases and has commercialized the first approved neonatal Fc receptor blocker in the U.S. and Japan.
February 10, 2022 – argenx (Euronext & Nasdaq: ARGX), a global immunology company focused on severe autoimmune diseases, will participate in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 10:40 a.m. ET. A live webcast can be accessed on their Investors section of the argenx website, with a replay available for 90 days. argenx is known for developing the first approved neonatal Fc receptor blocker in the U.S. and Japan and is advancing various treatments for autoimmune diseases.
VYVGART™ (efgartigimod alfa), the first and only FcRn blocker, has received approval from Japan's Ministry of Health, Labour and Welfare for treating adults with generalized myasthenia gravis (gMG) unresponsive to standard therapies. This marks the second regulatory approval following its U.S. authorization on December 17, 2021. The approval supports argenx's global strategy to enhance access to this innovative treatment. VYVGART demonstrated significant efficacy in the Phase 3 ADAPT trial, showcasing superior response rates compared to placebo, reinforcing its potential in managing gMG.
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.