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 (NASDAQ:ARGX) announced U.S. FDA approval expanding VYVGART and VYVGART Hytrulo to treat all adult gMG serotypes (anti-AChR, anti-MuSK, anti-LRP4 and triple seronegative) based on Phase 3 ADAPT SERON data, including a statistically significant primary endpoint (p=0.0068) and a 3.35‑point mean MG‑ADL improvement at week 4. The approval cites rapid, sustained symptom improvements and a tolerability profile consistent with prior data, and broadens prescribing to adults regardless of serotype. Access support is available via the My VYVGART Path program.
argenx (NASDAQ:ARGX) reported Q1 2026 results and a business update: $1.3B product net sales (+63% YoY), operating profit of $394M, profit for the period of $366M (+116% YoY), and cash and current financial assets of $4.9B as of March 31, 2026.
Key near-term catalysts include a PDUFA date for seronegative gMG on May 10, 2026, multiple upcoming topline readouts in 2026–2027, and pipeline progression toward 10 clinical candidates by end of 2026.
argenx (Euronext & Nasdaq: ARGX) announced that CEO Karen Massey will present at the BofA Securities 2026 Health Care Conference on Tuesday, May 12, 2026 at 10:40 a.m. PT.
A live webcast will be available at argenx.com/investors, with a replay accessible on the company website for approximately 30 days after the presentation.
argenx (Euronext & Nasdaq: ARGX) announced board changes following its Annual General Meeting on May 6, 2026. Karen Massey was appointed Chief Executive Officer and executive director for a four-year term, while co-founder Tim Van Hauwermeiren becomes Chairperson and non-executive director.
Shareholder turnout was 90.9% and all agenda items passed, including a shareholder authorization to issue shares or subscription rights up to 10% of outstanding capital for 18 months.
argenx (Euronext & Nasdaq: ARGX) will report its first quarter 2026 financial results and host a business update on May 7, 2026 at 2:30 PM CET / 8:30 AM ET. The company will hold a conference call and audio webcast for investors and analysts.
A live webcast is available at the Investors section of argenx.com/investors and a replay will remain accessible for approximately one year. Dial-in access numbers and access code 3810049 are provided; participants are asked to dial in 15 minutes early.
argenx (Nasdaq: ARGX) presented new VYVGART data at AAN 2026 showing expanded efficacy across myasthenia gravis (MG) subtypes and CIDP. ADAPT OCULUS met its primary endpoint (p=0.012) in ocular MG; sBLAs for oMG and broader gMG populations have regulatory submissions in progress, including a priority review target action date of May 10, 2026.
ADHERE post hoc and real-world data support early benefit and IVIg-to-Hytrulo switching in CIDP, and pediatric/adolescent ADAPT Jr results show durable symptom gains.
argenx (Euronext & Nasdaq: ARGX) announced its Annual General Meeting of shareholders will be held at 13:00 CET on Wednesday, May 6, 2026 at the Hilton Amsterdam Schiphol.
Agenda items include adoption of the 2025 annual accounts, advisory vote on the 2025 remuneration report, discharge of directors, share issuance authorization and several board appointments and reappointments. Documents and e-voting information are available on the argenx website and via ABN AMRO e-voting; shareholders are encouraged to vote by proxy. For copies contact legal@argenx.com.
argenx (NASDAQ: ARGX) will present clinical and real-world data for VYVGART and pipeline candidates at the 2026 AAN Annual Meeting (April 18–22, 2026) in Chicago.
Highlights include positive Phase 3 ADAPT OCULUS results in ocular myasthenia gravis, ADAPT SERON data showing efficacy in AChR‑Ab–negative gMG subtypes, CIDP biomarker and ADHERE analyses, and ARGX‑119 Phase 1b safety and functional improvements.
argenx (NASDAQ:ARGX) reported strong 2025 results: $4.2 billion in full‑year product net sales (≈+90% YoY) and ~$1.1 billion operating income, its first profitable year on an operating basis. The company announced positive ADAPT OCULUS oMG data and a PDUFA target date of May 10, 2026 for seronegative gMG.
argenx reiterated Vision 2030 goals, growth plans for the VYVGART franchise, multiple upcoming registrational readouts through 2026–2027, and expansion of its FcRn and broader immunology pipeline.
argenx (NASDAQ:ARGX) reported positive topline results from the Phase 3 ADAPT OCULUS trial of VYVGART in ocular myasthenia gravis (oMG) on February 26, 2026. The study met its primary endpoint (p=0.012) with a mean MGII PRO ocular score improvement of 4.04 for VYVGART vs 1.99 for placebo at Week 4.
Patients showed marked reductions in diplopia and ptosis; safety was consistent with prior studies and no new concerns were identified. Results support a planned sBLA submission to the FDA to expand the VYVGART label into oMG.