argenx announced it will discontinue the Phase 3 UNITY study of efgartigimod subcutaneous in Sjögren’s disease after an IDMC recommendation to stop for futility at interim analysis. The decision triggered an ~8.7% pre-market decline to $847.72, underscoring near-term downside risk to ARGX’s valuation and potential delays to its growth narrative.
argenx announced positive Phase 2 results for FB102, a first-in-class CD122 inhibitor, in adults with celiac disease. The primary endpoint—change in villus height-to-crypt depth at day 78—was met (p=0.0176), with supporting histologic, inflammatory, and symptomatic signals and no new safety concerns. The data, obtained after acquiring Forte Biosciences in Aug 2026, support Phase 3 development and potential broader autoimmune applications.
argenx announced positive topline Phase 3 ALKIVIA results for VYVGART Hytrulo in autoimmune myositis (IMNM+DM), meeting the primary endpoint with a 15.4-point mean TIS improvement at Week 52 (p=0.0011). Improvements appeared early (Week 4) and were sustained over a year, with the IMNM subgroup achieving significance (p=0.0048). A conference call is planned Aug 17; potential read-through could support near-term upside for ARGX and its FcRn strategy.
argenx is acquiring Forte Biosciences for $77 per share in cash, valuing Forte at about $2.2 billion. Forte's FB102 anti-CD122 antibody has Phase 1b signals in vitiligo and celiac disease, supporting a potential pipeline-in-a-product across autoimmune diseases. The deal is expected to close in Q3 2026, funded entirely from argenx's cash, subject to standard regulatory approvals.
Argenx updated its Phase 3 myositis plan, separating IMNM and DM analyses and dropping PM. HC Wainwright remains bullish on Vyvgart, citing IMNM's potential to exceed $1B in sales and meaningful DM upside. The stock rose about 4.7% following the meeting, reflecting investor appetite for clearer readouts and pipeline potential.
The FDA has approved a significant label expansion for Argenx's VYVGART, allowing its use in all serotype adult patients with generalized myasthenia gravis. This comes after positive Phase 3 trial results and could expand the addressable market significantly, potentially boosting revenue for ARGX substantially.