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 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 (p<0.0001). 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.
June 1, 2022 - argenx (ARGX), a company focused on autoimmune disease treatments, will participate in several key investor conferences this month. Events include the Jefferies 2022 Global Healthcare Conference on June 8 at 1:00 p.m. ET in New York, the Goldman Sachs 43rd Annual Global Healthcare Conference on June 15 at 3:20 p.m. PT in California, and the JMP Securities Life Sciences Conference also on June 15 in New York. Further details can be found on argenx's website.
argenx announced that its drug efgartigimod received a positive scientific opinion from the MHRA under the EAMS. This allows eligible patients with generalized myasthenia gravis (gMG) in the UK to access the treatment before official marketing authorization. The Medicine and Healthcare products Regulatory Agency granted efgartigimod a Promising Innovative Medicine (PIM) designation in November 2021. The European Medicines Agency is reviewing the marketing authorization application, with a decision expected in the second half of 2022.
argenx SE (Euronext & Nasdaq: ARGX) announced novel translational data from a Phase 2 study of efgartigimod for pemphigus, highlighting its potential role in autoimmune skin blistering disorders. The publication, presented at the Society for Investigative Dermatology Annual Meeting, reveals that efgartigimod treatment led to sustained reduction of antigen-specific B-cells, correlating with clinical improvement. The findings suggest efgartigimod may not only reduce IgG antibodies but also modulate B-cell activity and keratinocyte adhesion, addressing the unmet needs in pemphigus and bullous pemphigoid.