Argenx SE (NASDAQ:ARGX) on Monday disclosed positive topline results from its Phase 3 ALKIVIA study.

The trial evaluated VYVGART Hytrulo, or efgartigimod alfa and hyaluronidase-qvfc, in adults with autoimmune myositis. The study successfully achieved its primary endpoint (p=0.0011).

“For decades, people living with autoimmune myositis have relied on corticosteroids and broad immunosuppression, and those with IMNM have had no approved option at all. These are the first Phase 3 results to show that precision targeting of FcRn with efgartigimod can deliver meaningful benefit in this disease,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. “The patient response to efgartigimod was durable and multidimensional: separation from placebo emerged early and held through a full year of treatment, with a treatment effect of comparable magnitude in IMNM and DM. This confirms that pathogenic IgG autoantibodies are key drivers of autoimmune myositis. We are grateful to the patients, caregivers, and investigators who made this pioneering study possible.”

Argenx shares rose 0.2% to $989.53 in pre-market trading.

These analysts made changes to their price targets on Argenx following the announcement.

  • HC Wainwright & Co. analyst Douglas Tsao maintained the stock with a Buy and raised the price target from $940 to $1202.
  • Wedbush analyst David Nierengarten maintained the stock with an Outperform rating and raised the price target from $1050 to $1150.
  • Citizens analyst Jason N. Butler maintained the stock with a Market Outperform and boosted the price target from $932 to $1200.

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