Recent Updates — ARGX
argenx SE reported third quarter 2026 financial results showing global product net sales of $1.7 billion, a 54% increase from the prior year and 13% growth quarter-over-quarter. Operating profit reached $486 million, driven by strong VYVGART performance in generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. The company also announced positive Phase 3 ALKIVIA results for VYVGART Hytrulo in immune-mediated necrotizing myopathy and dermatomyositis, with a supplemental biologics license application on track for submission by year-end. Additionally, argenx advanced FB102 to Phase 3 in celiac disease based on positive Phase 2 data. Full-year combined R&D and SG&A expenses are now expected to be approximately $4 billion, including acquisition-related costs from the Forte Biosciences Inc. transaction. The company operates as an immunology innovation firm focused on developing treatments for autoimmune diseases.
The global Phase 3 ALKIVIA study evaluating VYVGART Hytrulo (efgartigimod) in patients with autoimmune myositis, specifically immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM), met its primary endpoint. The treatment achieved a statistically significant 15.4-point greater improvement in mean Total Improvement Score (TIS) versus placebo at Week 52 in the combined population (47.95 vs. 32.56; p=0.0011). Improvements were observed as early as Week 4 and sustained through 52 weeks, even with corticosteroid tapering. A greater proportion of patients achieved a TIS of 40 or more, indicating noticeable clinical benefit. The drug demonstrated a well-tolerated safety profile consistent with prior studies. These results will be presented as a late-breaking oral presentation at the American College of Rheumatology (ACR) Convergence 2026 on November 11. argenx is an immunology innovation company focused on developing treatments for underserved diseases through novel biology and antibody fragment technologies.
Argenx announced positive topline results from a Phase 2 study of FB102, a first-in-class CD122 inhibitor, in adults with celiac disease. The trial met its primary endpoint of change from baseline in the ratio of villus height-to-crypt depth (Vh:Cd) at day 78 versus placebo (p=0.0176). Based on these findings and a consistent safety profile, the company plans to advance FB102 into Phase 3 development. In a separate announcement, argenx will discontinue the Phase 3 UNITY study of efgartigimod subcutaneous in Sjögren's disease after an Independent Data Monitoring Committee recommended stopping for futility following an interim analysis. The company operates as a global immunology innovation company developing antibody-based medicines for severe autoimmune diseases.
On August 27, 2026, argenx SE completed its acquisition of Forte Biosciences Inc. for $77.00 per share in cash. The transaction involved a tender offer and subsequent merger, resulting in argenx owning approximately 87.13% of Forte's outstanding shares immediately following the expiration on August 26, 2026. This acquisition adds FB102, a first-in-class anti-CD122 antibody with clinical proof-of-concept in vitiligo and celiac disease, to argenx’s immunology pipeline. The company operates as a global immunology innovation company developing novel antibody-based medicines for severe autoimmune diseases.
On August 17, 2026, argenx SE announced positive topline results from the Phase 3 ALKIVIA trial of efgartigimod (VYVGART Hytrulo) for autoimmune myositis. The study met its primary endpoint in the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) population, showing a statistically significant 15.4-point greater improvement in mean Total Improvement Score at Week 52 versus placebo (p=0.0011). Efgartigimod also demonstrated a clinically meaningful benefit in the IMNM subtype with no approved therapy, achieving statistical significance (p=0.0048) and a 14.8-point improvement over placebo. The treatment effect was rapid, sustained through one year, and consistent across muscle and skin measures. argenx is a global immunology innovation company developing antibody-based medicines for severe autoimmune diseases.