Argenx SE (NASDAQ:ARGX) on Monday announced it would discontinue the Phase 3 UplighTED studies evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate to severe thyroid eye disease (TED).The decision is based on the recommendation from an Independent Data Monitoring Committee (IDMC) to stop the trials for futility following its review of data from a pre-specified interim analysis.Efgartigimod showed a favorable safety and tolerability profile, and no new ...

Core Insights - Nipocalimab, an investigational FcRn blocker for Sjögren's disease (SjD), achieved significant improvement in disease activity as measured by the ClinESSDAI score in the Phase 2 DAHLIAS study [1][2][5] - The treatment demonstrated a favorable safety profile, with no new safety signals observed during the 24-week treatment period [4][5] - The Phase 3 DAFFODIL study is currently enrolling patients, building on the momentum from the positive Phase 2 results [5][11] Study Findings - The primary endpoint of the DAHLIAS study was met, showing a statistically significant improvement in the ClinESSDAI score at Week 24 for the nipocalimab 15 mg/kg Q2W group compared to placebo [2][12] - Key biomarkers indicated reductions in disease activity, including lower rheumatoid factor levels and decreased inflammatory markers [2][4] - Patients treated with nipocalimab reported improvements in hallmark SjD symptoms such as dryness, fatigue, and joint pain, with objective salivary flow increasing by at least 50% in 33% of patients compared to 16% in the placebo group [3][4] Regulatory Designations - Nipocalimab is the only investigational treatment to receive Breakthrough Therapy Designation from the U.S. FDA for moderate-to-severe SjD [5][19] - The treatment also received Fast Track Designation earlier in April 2025, indicating regulatory support for its development [5][19] Unmet Medical Need - Sjögren's disease affects approximately four million people globally, with a significant unmet need for effective therapies, particularly as 90% of patients are women [9][5] - The disease is characterized by debilitating symptoms and a high burden comparable to rheumatoid arthritis, highlighting the importance of developing new treatment options [9][5]