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]