argenx SE Discontinues Phase 3 UNITY Study for Sjögren's Disease

argenx SE announced the discontinuation of the Phase 3 UNITY study for efgartigimod subcutaneous in adults with moderate-to-severe Sjögren's disease. The decision followed a recommendation from the Independent Data Monitoring Committee (IDMC) to stop the study for futility after an interim analysis. The IDMC concluded that the UNITY study was unable to meet its primary endpoint, though safety remained consistent with efgartigimod's established profile.

The discontinuation of this Phase 3 trial impacts the potential commercial viability of efgartigimod for Sjögren's disease. The outcome suggests that the drug may not meet the necessary clinical benchmarks for regulatory approval in this specific indication, affecting argenx SE's pipeline.