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News
Argenx has halted its late-stage trial of efgartigimod (Vyvgart) in Sjögren's disease after an interim analysis suggested the drug was unlikely to hit its primary endpoint. The news sent shares tumbling 16%, wiping nearly $9.5 billion off the company's market value. Sjögren's remains a condition with no approved treatments, leaving a significant unmet need unaddressed.
Argenx has discontinued its Phase 3 trial of efgartigimod (Vyvgart) in adults with Sjögren's disease — an autoimmune condition that damages tear and saliva glands — after an independent data monitoring committee recommended stopping the study. The committee's decision followed an interim analysis concluding the trial was unlikely to meet its primary endpoint.
The setback is a notable blow for Argenx, which had positioned rheumatology as a key growth frontier for Vyvgart. The drug has already achieved considerable success in Europe through its use in two other autoimmune diseases, and analysts had viewed the Sjögren's trial as a strong opportunity given the condition's high unmet need and complete lack of approved therapies.
By the Numbers:
Why it matters: Sjögren's disease affects millions worldwide with zero approved treatments, making every failed trial a setback for patients and clinicians alike. For Argenx, the discontinuation raises questions about Vyvgart's broader rheumatology ambitions and underscores the ongoing challenges of expanding autoimmune therapies into new indications.
