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 (ARGX) signed a definitive agreement to acquire Unnatural Products, adding peptide discovery capabilities to its immunology research platform. Already a minority shareholder, argenx will acquire all remaining shares. The terms include $550 million upfront from cash on hand and up to $595 million contingent on specified development and regulatory milestones, for total potential consideration of up to approximately $1.15 billion.
Both boards approved the transaction, which argenx expects to close by year-end, subject to customary closing conditions. The company sees potential to develop oral or long-acting medicines by pairing UNP’s macrocyclic peptides—ring-shaped molecules—with its antibody engineering. After closing, UNP’s current team and leadership will remain in Santa Cruz, California, and lead discovery within an agreed framework; argenx will provide clinical development and commercialization capabilities.
argenx (ARGX) reported that Phase 3 ALKIVIA met its primary and key secondary endpoints for efgartigimod in combined autoimmune myositis populations.
In patients with immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM), the mean Total Improvement Score, a measure of treatment response, was 48.0 versus 32.6 on placebo at Week 52, a 15.4-point difference (p=0.0011). Key secondary endpoints covered response rate, time to response, muscle strength and disease activity. IMNM patients had a 14.8-point greater improvement versus placebo (p=0.0048). The DM cohort showed a 14.5-point greater improvement, but did not reach statistical significance (p=0.1093). Efgartigimod was generally well tolerated, with safety consistent with prior studies. argenx plans an FDA supplemental approval application for IMNM by the end of 2026, supported by Breakthrough Therapy Designation.
argenx (ARGX) announced that management will participate in two investor conferences in November, with fireside chats in Boston and London.
The Guggenheim 3rd Annual Healthcare Innovation Conference chat is November 10 at 2:00 p.m. ET; the Jefferies London Global Healthcare Conference chat is November 17 at 8:30 a.m. GMT. Live webcasts will be accessible through the company’s investor website, with replays available for approximately 30 days.
argenx (ARGX) reported third-quarter 2026 global product net sales of $1.7 billion, up 54% from a year earlier. Sales rose 13% quarter over quarter. Net profit reached $506 million, versus $344 million, and diluted profit per share rose to $7.80 from $5.18.
Cash, cash equivalents and current financial assets totaled $3.7 billion after approximately $2.1 billion paid for Forte Biosciences, net of acquired cash. argenx expects approximately $4 billion in combined research and development and selling, general and administrative expenses for 2026, including Forte transaction-related costs.
Positive Phase 3 ALKIVIA results support a planned year-end 2026 application for VYVGART Hytrulo in immune-mediated necrotizing myopathy; an additional registrational study is planned in dermatomyositis. argenx expects Phase 3 empasiprubart results in multifocal motor neuropathy in December 2026 and is advancing FB102 to Phase 3 in celiac disease.
argenx (ARGX) announced that its Phase 3 ALKIVIA trial of efgartigimod in autoimmune myositis met its primary endpoint versus placebo. At Week 52, the combined population with immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) achieved a mean Total Improvement Score (TIS), a measure of disease improvement, of 47.95 versus 32.56. The improvement was 15.4 points greater with efgartigimod (p=0.0011).
Disease activity improvements appeared as early as Week 4 and persisted through 52 weeks, even with steroid tapering. In both subtypes, a greater proportion of patients receiving efgartigimod reached TIS ≥ 40, and the median time to that threshold was shorter than with placebo. The results will be presented in a late-breaking oral session at ACR Convergence 2026 in Orlando on November 11, from 9:15–9:30 a.m. ET.
argenx (ARGX) will discuss its third-quarter 2026 financial results and provide a business update on October 22, 2026. The conference call and audio webcast will begin at 2:30 PM CET (8:30 AM ET). The webcast will be accessible through the Investors section of argenx.com, with a replay available for approximately one year following the presentation.
argenx (ARGX) announced that its Phase 2 study of FB102 in adults with celiac disease met its primary endpoint. FB102 showed a statistically significant effect versus placebo on the change from baseline in villus height-to-crypt depth ratio, a measure of intestinal tissue structure, at day 78 (p=0.0176) during a gluten challenge. Measures of intestinal immune-cell density, a composite tissue score and symptoms were consistent with the primary endpoint. The safety profile was consistent with prior studies, with no new safety signals identified.
argenx plans to advance FB102 into Phase 3 development and share detailed Phase 2 results at an upcoming medical meeting. This was the first FB102 clinical readout following its acquisition of Forte Biosciences in August 2026. FB102 has FDA Fast Track designation for celiac disease and remains under evaluation for vitiligo and alopecia areata.
argenx (ARGX) will discontinue its Phase 3 UNITY study of subcutaneous efgartigimod in adults with moderate-to-severe Sjögren's disease.
An Independent Data Monitoring Committee recommended stopping for futility following an interim analysis, concluding that the study could not meet its primary endpoint. That endpoint measured change from baseline in systemic disease activity at Week 48 using clinESSDAI, a clinical disease-activity index. Safety was consistent with efgartigimod's established profile, with no new safety signals identified.
UNITY was randomized, double-blind and placebo-controlled, with an open-label extension. Patients were assigned equally to weekly efgartigimod SC or placebo. After study close and database lock, argenx plans an in-depth data analysis to understand the outcome and generate insights that may inform future Sjögren's research.
argenx (ARGX) reported new VYVGART results in myasthenia gravis (MG) and CIDP alongside neuromuscular pipeline data.
Phase 3 ocular MG scores improved further after two additional treatment cycles in antibody-positive and triple-seronegative patients. In anti-AChR antibody-negative generalized MG, mean daily-activity score improvements of approximately 5 points were maintained through Week 52. A U.S. analysis of more than 1,100 patients associated earlier VYVGART treatment with greater improvement.
In CIDP, an interim analysis followed patients beyond five years. A Phase 4 study found 87% remained on VYVGART Hytrulo through 12 weeks after starting it one week after their last IVIg dose. Phase 2 empasiprubart data in multifocal motor neuropathy and Phase 1b adimanebart walking measures in congenital myasthenic syndrome also showed improvements.
argenx (ARGX) reports the results of its Extraordinary General Meeting of Shareholders and the appointment of Thomas M. Brakel and Khurem Farooq as non-executive directors to the Board.
Chairperson Tim Van Hauwermeiren said the new directors bring leadership and expertise that support argenx’s long-term “Vision 2030,” focused on scientific innovation, shareholder value and patient impact. Detailed voting results and related meeting documents are made available on the company’s investor website.