argenx Provides Update on Phase 3 UNITY Study of Efgartigimod SC in Sjögren's Disease

argenx (ARGX) halted its Phase 3 UNITY trial for efgartigimod in Sjögren’s disease after the IDMC recommended stopping due to futility. The trial failed to meet its primary endpoint, though safety results aligned with expectations. The company will analyze data for future research. Efgartigimod is approved for other autoimmune diseases.

argenx reported positive Phase 2 results for FB102 in celiac disease, meeting the primary endpoint. The company plans to advance to Phase 3. According to the company, no new safety signals were observed.

argenx SE (ARGX) will halt its Phase 3 UNITY trial of efgartigimod SC in Sjögren's disease due to futility, following an IDMC recommendation. The company reports safety data were consistent with prior findings. This marks a setback in argenx's efforts to expand the drug's use in autoimmune diseases.

argenx reported positive Phase 2 results for FB102, a CD122 inhibitor, in celiac disease. The study met its primary endpoint (p=0.0176) and showed efficacy across multiple measures. The company plans to advance FB102 into Phase 3 development. FB102 is also being evaluated for other autoimmune diseases.

Argenx (ARGX) initiated a Phase 2 study for empasiprubart as an add-on therapy for Guillain-Barré syndrome. The study aims to assess efficacy and safety when combined with standard IVIg treatment. The trial is not yet recruiting, with primary readouts expected after approximately 67 weeks of follow-up per patient. Success could expand ARGX's portfolio beyond autoimmune diseases, though near-term valuation impact is expected to be modest.

Argenx (NASDAQ: ARGX) reported 18 consecutive quarters of revenue growth, with Q2 2026 sales up 60% YoY. Its Vyvgart therapies are driving growth, and the company expects multiple pivotal clinical results through 2027. Analysts rate it a buy with a 14% upside. Argenx's stock has more than doubled in three years.