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 (NASDAQ:ARGX) announced the FDA accepted a supplemental BLA for VYVGART in AChR‑Ab seronegative generalized myasthenia gravis with Priority Review and a PDUFA target action date of May 10, 2026. The sBLA is supported by Phase 3 ADAPT SERON (n=119), which met its primary endpoint (p=0.0068) with a mean MG‑ADL improvement of 3.35 points at week 4 versus placebo. Efficacy signals and MG‑ADL/QMG improvements were seen across MuSK+, LRP4+, and triple seronegative subgroups. VYVGART safety was consistent with its established profile and no new safety concerns were identified.
argenx (ARGX) reported preliminary full-year 2025 global product net sales of $4.15 billion (approximately +90% YoY) and fourth-quarter sales of $1.29 billion. The company says ~19,000 patients are on VYVGART treatment and expects multiple registrational readouts in 2026, including the first for empasiprubart and topline ocular MG results in Q1 2026. argenx plans to have 10 clinical-stage molecules by end-2026 and to advance FcRn franchise candidates (ARGX-213, ARGX-124). A potential label expansion for seronegative gMG via an sBLA could lead to a launch by end-2026 if approved. Management succession and other corporate changes are subject to shareholder approval in May 2026.
argenx (Euronext & Nasdaq: ARGX) announced that CEO Tim Van Hauwermeiren will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 8:15 a.m. PT.
A live webcast will be available on the company's Investors website at argenx.com/investors, and a replay will be accessible on the site for approximately 30 days after the presentation.
argenx (NASDAQ:ARGX) announced a leadership transition effective January 5, 2026: Chief Operating Officer Karen Massey will become Chief Executive Officer and Executive Director, and current CEO Tim Van Hauwermeiren will move to Non‑Executive Director and Chairman of the Board.
The Board said Tim will succeed Peter Verhaeghe, who is retiring after serving since 2008. The changes are subject to shareholder approval at the Annual General Meeting on May 6, 2026, providing a comprehensive transition period.
argenx (NASDAQ: ARGX) announced on December 15, 2025 that the Phase 3 UplighTED studies of efgartigimod SC in adults with moderate-to-severe thyroid eye disease (TED) will be discontinued after an Independent Data Monitoring Committee recommended stopping for futility following a pre-specified interim analysis.
The IDMC reviewed unblinded data from patients completing 24 weeks. Efgartigimod showed a favorable safety and tolerability profile with no new safety signals. Argenx will close out the studies, lock the databases, and perform a comprehensive analysis; data will be shared at a future medical meeting.
argenx (Euronext & Nasdaq: ARGX) announced the results of its Extraordinary General Meeting held on November 18, 2025 in Amsterdam.
The sole agenda item, the company’s remuneration policy, was approved by the required majority with 95.67% of votes in favor and 91.1% of share capital represented at the meeting. Voting results and all related meeting documents are available on the company’s investor website at www.argenx.com/investors/shareholder-meetings.
argenx (NASDAQ:ARGX) reported $1.13 billion in third-quarter 2025 global product net sales and total operating income of $1.15 billion for the quarter.
Q3 operating profit was $346 million and profit for the period was $344 million. Cash and current financial assets totaled $4.3 billion as of September 30, 2025. Management reaffirmed combined R&D and SG&A guidance of ~$2.5 billion and outlined near-term development milestones including an sBLA filing for seronegative gMG by year-end 2025 and topline ADAPT-OCULUS results in 1H26. The company expects five registrational readouts in 2026 and expanded a FUJIFILM manufacturing partnership with a new North Carolina site.
argenx (NASDAQ:ARGX) reported new VYVGART data at AANEM and MGFA (Oct 29–Nov 1, 2025) showing efficacy across generalized myasthenia gravis (gMG) populations.
Key findings: Phase 3 ADAPT SERON met its primary endpoint (p=0.0068) with a mean MG-ADL improvement of 3.35 at Week 4 in AChR‑Ab seronegative patients; ADAPT‑SC+ long‑term data showed 59.2% achieved minimal symptom expression (MSE) and 88.1% of responders sustained MSE ≥4 weeks; real‑world analysis reported 72.5% of patients tapered steroids and mean daily glucocorticoid dose fell from 16.6 to 7.5 mg at 18 months. No new safety signals were identified.
argenx (Euronext & Nasdaq: ARGX) will report third quarter 2025 financial results and provide a business update via a conference call and audio webcast on Thursday, October 30, 2025 at 1:30 PM CET (8:30 AM ET).
Investors can access the live webcast and a replay (available for ~one year) on the company's Investors website at argenx.com/investors. Dial‑in access is available across multiple countries using access code 3810049; participants are asked to dial in 15 minutes before the call.
argenx (NASDAQ:ARGX) will present more than 40 abstracts at the 2025 AANEM Annual Meeting and MGFA Scientific Session (Oct 29–Nov 1, 2025) covering VYVGART (IV and SC/Hytrulo) and pipeline candidate empasiprubart.
Key highlights include pivotal ADAPT SERON results showing clinically meaningful improvements with VYVGART in anti-AChR antibody–negative generalized myasthenia gravis across triple negative, MuSK, and LRP4 subtypes; interim ADAPT Jr data in juvenile gMG; long-term and real-world evidence for sustained benefit; and Phase 2/3 programs for empasiprubart in CIDP and MMN (EMVIGORATE, EMNERGIZE, EMPASSION).