On August 17, Argenx SE rose 9.45% in regular trading, trading at $933.21/share, with turnover of $33.84 million. The stock surged after the company announced that its drug efgartigimod (marketed as Vyvgart Hytrulo) met the primary endpoint in the Phase 3 ALKIVIA trial evaluating treatment in adults with autoimmune myositis.

Trial data showed patients treated with efgartigimod achieved a statistically significant improvement of 15.4 points in mean total improvement score at week 52 compared with placebo. Treatment benefits emerged as early as week 4 and were sustained through the full 52-week period, including during steroid tapering. Notably, the trial also demonstrated a 14.8-point improvement in the immune-mediated necrotizing myopathy (IMNM) subgroup, marking the first Phase 3 study to show significant improvement in a disease subtype with no currently approved therapies. Autoimmune myositis affects approximately 100,000 people in the US, representing a substantial unmet medical need. The company plans to file for accelerated approval for IMNM and will discuss dermatomyositis submission with the FDA.

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