Argenx reported an unusual setback in Sjögren’s disease after Vyvgart failed to outperform placebo in a Phase 3 trial, prompting a stock drop and overshadowing a concurrent celiac-disease win. The company said the monitoring board recommended stopping for futility in the late-stage study, removing what had been a major expansion opportunity. The outcome will likely recalibrate expectations for Vyvgart’s broader autoimmune positioning and could affect timelines for label expansion strategies. It also adds to the scrutiny on late-stage endpoint robustness in autoimmune indications where biologic mechanisms may not translate cleanly to clinical benefit across heterogeneous patient populations. Investors and partners will watch for next steps: resubmission prospects, subgroup analyses, and whether additional evidence supports continued development in adjacent disease settings.
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