On August 17, Argenx SE rose 5% in pre-market trading, trading at $918.18/share, with turnover of $49,500.
The move was driven by the company announcing that its drug Vyvgart Hytrulo (efgartigimod) met the primary endpoint in a Phase 3 clinical trial evaluating its efficacy in adults with autoimmune myositis. Patients treated with the drug showed a statistically significant improvement in mean total improvement score at week 52 compared with placebo, with a 15.4-point advantage. Treatment benefits emerged as early as week 4 and were sustained through the 52-week treatment period, including during steroid tapering. Notably, the trial also demonstrated significant improvement in immune-mediated necrotizing myopathy (IMNM), a disease subtype with no currently approved therapies, marking the first Phase 3 trial to show meaningful efficacy in this indication. The data reinforces the expanding clinical utility of Argenx's FcRn platform beyond its approved indications in generalized myasthenia gravis and CIDP.
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