Argenx's Vyvgart fails to beat placebo in Phase 3 Sjögren's study

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  • STAT reports that argenx said its blockbuster drug Vyvgart did not outperform placebo in a Phase 3 trial in patients with Sjögren's disease, a chronic autoimmune disorder.
  • STAT frames it as an unusual setback for a franchise that has mostly succeeded in label expansion; detailed data were not visible in the public lede.
💡 Points

Sjögren's was pitched as one of the larger expansion opportunities, so this trims the long-term sales ceiling without touching the core neuromuscular franchise. It also muddies the read-across for other Sjögren's programs: if FcRn blockade alone is not enough, bets on mechanisms that hit the disease upstream, such as Amgen's dazodalibep, look relatively better.

STAT+: Argenx sees unusual setback with failure of late-stage study of drug for autoimmune disease ↗

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