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 (ARGX) will host a conference call and audio webcast on October 27, 2022, at 2:30 pm CET to discuss its third quarter 2022 financial results and provide a business update. The event can be accessed via the Investors section of the argenx website. The company is known for its commitment to developing novel antibody-based medicines for severe autoimmune diseases, including its first-and-only approved neonatal Fc receptor (FcRn) blocker.
argenx SE (ARGX) announced the submission of a Biologics License Application (BLA) for subcutaneous (SC) efgartigimod to the U.S. FDA for treating generalized myasthenia gravis (gMG) in adults. This follows positive results from the Phase 3 ADAPT-SC trial, where SC efgartigimod demonstrated noninferiority to intravenously administered VYVGART in reducing total immunoglobulin G (IgG) levels after 29 days. Key data included a 66.4% mean reduction in total IgG levels for SC efgartigimod compared to 62.2% for VYVGART. The safety profile was consistent with prior studies, with injection site reactions being the most common side effects.
argenx SE (NASDAQ: ARGX) presented new data at the AANEM Annual Meeting, highlighting the effectiveness and safety of VYVGART (efgartigimod alfa-fcab) for treating generalized myasthenia gravis (gMG). Findings from the ADAPT+ study indicate consistent improvements in patient function and strength over multiple years. New pooled data reveal significant disease score improvements in seronegative gMG patients. The presentations emphasize argenx's commitment to innovation in treating autoimmune diseases, supported by 17 scientific abstracts accepted at the meetings.
argenx announces the appointment of Mrs. Camilla Sylvest as a non-executive director to its Board during an extraordinary general meeting held on September 8, 2022. With extensive experience in scaling global pharmaceutical organizations, Mrs. Sylvest's leadership is expected to enhance company culture and sustainability initiatives. This strategic move aims to strengthen the company's position in the field of immunology and support its mission to advance treatments for severe autoimmune diseases. Further details from the meeting can be found on the company's website.
argenx (Euronext & Nasdaq: ARGX) will participate in a fireside chat at the Wells Fargo Healthcare Conference on September 7, 2022, at 8:00 a.m. E.T. in Boston, MA. The presentation will be accessible via live webcast on the Investors section of the argenx website, with a replay available for 90 days. argenx focuses on treating severe autoimmune diseases and is known for developing the first approved neonatal Fc receptor blocker in the U.S., EU, and Japan, while also advancing multiple experimental medicines.
VYVGART has received approval from the European Commission for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. The approval is based on the Phase 3 ADAPT trial, which showed a 68% response rate on the Myasthenia Gravis Activities of Daily Living scale compared to 30% for placebo (p0.0001). This therapy is the first neonatal Fc receptor blocker approved in the EU and will provide a targeted treatment option for gMG patients, addressing a significant unmet medical need.
argenx SE, a global immunology company, announced an extraordinary general meeting on September 8, 2022, at 18:30 PM CEST in Amsterdam. The meeting's agenda focuses on the proposed appointment of Mrs. Camilla Sylvest as a non-executive director. Shareholders can attend in person or via proxy voting, with arrangements detailed on the argenx website. The company is recognized for its innovative approach to serious autoimmune diseases, including developing the first approved FcRn blocker in the U.S. and Japan.
argenx SE reported strong second-quarter results with global net product sales of $75 million from its VYVGART® (efgartigimod alfa-fcab) launch in the U.S. and Japan. The company anticipates European approval in Q3 2022 and has filed a Biologics License Application (BLA) in China. Despite positive sales, argenx faces challenges with a net loss of $208.7 million for the quarter. Operating expenses rose to $259.7 million, primarily driven by R&D and SG&A costs. The company forecasts a cash burn of up to $1 billion for 2022 to support ongoing initiatives.
argenx will host a conference call on July 28, 2022, at 2:30 pm CET (8:30 am ET) to discuss its half-year 2022 financial results and provide a second quarter business update. Investors can access the live call via the Investors section of the argenx website. The call will include a webcast replay available for one year. Investors are encouraged to dial in 15 minutes early using access code 3810049 for efficient participation.
argenx announced a positive opinion from the CHMP for its drug efgartigimod, designed for adults with generalized myasthenia gravis (gMG) who are anti-AChR antibody positive. This recommendation indicates that the European Commission (EC) will decide on marketing authorization within approximately 60 days. If approved, efgartigimod will be the first FcRn blocker for gMG in Europe. The Phase 3 ADAPT trial demonstrated significant improvements in patients' strength and quality of life, reporting 68% responder rates on the MG-ADL scale compared to 30% for placebo. Efgartigimod has shown a favorable safety profile.