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 reported strong financial results for 2024, with global product net sales reaching $737 million in Q4 and $2.2 billion for the full year. The company received positive CHMP recommendation for VYVGART pre-filled syringe for gMG in the EU, with FDA decisions expected by April 10, 2025.
The company surpassed 10,000 patients across three indications with VYVGART and expects to become profitable in 2025. argenx is advancing its Vision 2030 strategy, aiming to treat 50,000 patients globally, secure 10 labeled indications, and advance five pipeline candidates to Phase 3.
Key developments include 20 ongoing clinical studies (10 Phase 3 and 10 Phase 2) across their pipeline in 2025. The company recognized a one-time tax benefit of $725 million related to previously unrecognized deferred tax assets. Full-year 2024 profit was $833 million, compared to a loss of $295 million in 2023.
argenx, a global immunology company focused on improving lives of people with severe autoimmune diseases, has announced that Tim Van Hauwermeiren, Chief Executive Officer, will present at the TD Cowen 45th Annual Healthcare Conference. The presentation is scheduled for Monday, March 3, 2025 at 11:50 a.m. ET.
Investors and interested parties can access a live webcast of the presentation through the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will remain available on the company website for approximately 30 days following the presentation.
argenx is listed on both Euronext and Nasdaq under the ticker symbol ARGX.
argenx (Euronext & Nasdaq: ARGX), a global immunology company focused on severe autoimmune diseases, has announced it will host a conference call and audio webcast on Thursday, February 27, 2025, at 2:30 PM CET (8:30 AM ET) to discuss its full year 2024 financial results and provide a fourth quarter business update.
The webcast will be accessible through the Investors section of the argenx website, with a replay available for approximately one year. The company has provided international dial-in numbers for Belgium, France, Netherlands, United Kingdom, United States, Japan, and Switzerland, with access code 3810049 for participants to join the call.
argenx reported preliminary global product net sales of $2.2 billion for full-year 2024, including $737 million in Q4 sales. The company announced its 2025 strategic priorities, focusing on expanding VYVGART's global reach and launching VYVGART SC as a pre-filled syringe, with FDA PDUFA scheduled for April 2025.
The company plans to execute 10 registrational and 10 proof-of-concept studies across its pipeline products: efgartigimod, empasiprubart, and ARGX-119. Four new pipeline molecules will be advanced in 2025. argenx expects to transition to sustainable profitability in 2025, with projected R&D and SG&A expenses of approximately $2.5 billion.
As of December 31, 2024, argenx had approximately $3.4 billion in cash, cash equivalents, and current financial assets.
argenx (Euronext & Nasdaq: ARGX), a global immunology company focused on severe autoimmune diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Tim Van Hauwermeiren, the company's CEO, will deliver a presentation on Monday, January 13, 2025 at 9:45 a.m. PT.
The presentation will be accessible through a live webcast on the Investors section of the argenx website (argenx.com/investors). A replay option will remain available on the company's website for approximately 30 days after the presentation.
argenx announced that Japan's MHLW has approved VYVDURA for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The treatment is administered as a weekly 30-90 second subcutaneous injection that can be self-administered at home, making it the first FcRn blocker approved for CIDP treatment in Japan.
The approval is based on the ADHERE Study, which showed that 69% of VYVDURA-treated patients demonstrated clinical improvement, with a 61% reduction in relapse risk versus placebo. The study was the largest clinical trial for CIDP to date, with 99% of participants continuing in the extension phase.
This marks VYVDURA's third approved indication in Japan, following its earlier approval for generalized myasthenia gravis (gMG) in January 2024.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, has announced its management team's participation in three major healthcare conferences this December. The schedule includes presentations at Citi's 2024 Global Healthcare Conference in Miami (December 3), the 7th Annual Evercore I&I HealthCONx Conference in Coral Gables (December 4), and Piper Sandler's 35th Annual Healthcare Conference in New York (December 5). All presentations will be fireside chats, with additional information available on the company's investor relations website.
Argenx announced the continuation of efgartigimod SC development in the Phase 2/3 ALKIVIA study for idiopathic inflammatory myopathies (IIM) following successful Phase 2 results. The study met its primary endpoint, showing statistically significant improvement in total improvement score (TIS) at Week 24 compared to placebo. The trial will continue enrolling patients across three myositis subtypes: immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM). The ALKIVIA study aims to enroll 240 patients total, with safety and tolerability profile consistent with previous clinical trials.
VYVGART Hytrulo has received NMPA approval in China for treating adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), becoming the first and only approved therapy for this condition in the country. The treatment, administered as a weekly 30-to-90 second subcutaneous injection, demonstrated significant efficacy in clinical trials, showing a 69% reduction in relapse risk compared to placebo in Chinese participants. The approval was based on the ADHERE study results, where 78% of Chinese participants showed clinical improvement during the open-label period.
Zai Lab and argenx announced NMPA approval of VYVGART Hytrulo for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in China. This marks the first and only approved CIDP treatment in China, administered as a weekly 30-90 second subcutaneous injection. The approval is based on the ADHERE study, where Chinese participants showed a 69% reduction in relapse risk compared to placebo, with 78% demonstrating clinical improvement. The treatment addresses approximately 50,000 diagnosed CIDP patients in China, offering a new option beyond traditional corticosteroids and plasma-derived therapies.
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