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.
argenx reported a remarkable 90% growth in sales, reaching $4.2 billion for 2025, alongside a $1.1 billion operating income, marking its first year of profitability. The positive phase 3 results for VYVGART bolster its label expansion efforts ahead of the upcoming PDUFA date in May 2026, indicating robust growth potential. The company's ambitious goals for 2030 aim to reach 50,000 patients and secure 10 indications.
The Phase 3 ADAPT OCULUS study for VYVGART achieved its primary endpoint, showcasing significant improvements in ocular symptoms of myasthenia gravis (oMG) with a p-value of 0.012. This sets the stage for a Supplemental Biologics License Application (sBLA) to the FDA, potentially expanding the treatment's label and enhancing revenue prospects for argenx.
