Core Insights - Argenx SE has decided to discontinue the Phase 3 UplighTED studies for efgartigimod in adults with moderate to severe thyroid eye disease (TED) based on an Independent Data Monitoring Committee's recommendation due to futility [1][3] Study Design and Outcomes - The Phase 3 studies aimed to evaluate the efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of efgartigimod PH20 SC in adult participants with TED, with the primary endpoint being the percentage of participants who were proptosis responders at week 24 [4] - Key secondary endpoints included changes in proptosis measurement, total Graves' Orbitopathy Quality of Life (GO-QoL) score, and the percentage of participants with resolution of diplopia at week 24 [5] Safety Profile - Efgartigimod demonstrated a favorable safety and tolerability profile, with no new safety signals identified during the trials [2] Market Implications - The discontinuation of the studies raises questions about the biological differences between TED and related conditions, as noted by analysts [6] - Amgen's Tepezza is currently the only FDA-approved drug for TED, while Viridian Therapeutics' veligrotug is expected to receive FDA approval in 2026 [7] - Analyst projections for peak TED sales for Vyvgart are estimated at $550 million, assuming a 60% probability of success, indicating a secondary opportunity compared to larger programs [7] - Following the news, Argenx shares fell by 4.86% to $835.31 [8]

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]