On October 8, 2026, argenx said it would discontinue UNITY, its Phase 3 study of subcutaneous efgartigimod (Vyvgart Hytrulo) in adults with moderate-to-severe Sjögren’s disease.
An independent data monitoring committee recommended stopping after an interim review found the study was unlikely to meet its primary endpoint:
change in disease activity on the clinESSDAI scale at Week 48.
The company reported no new safety signals; the setback concerns the treatment’s effectiveness in this indication, not a newly identified safety issue.
argenx plans a full analysis after the study closes and the database is locked. The outcome ends a potential Sjögren’s label expansion for now.
The news weighed on argenx shares, with reports describing a sharp decline. Analysts also noted the challenge of high placebo responses in Sjögren’s trials.
Sources:
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