Argenx SE announced that it will discontinue its Phase 3 UplighTED studies of efgartigimod subcutaneous (efgartigimod alfa and hyaluronidase‑qvfc) in adults with moderate to severe thyroid eye disease (TED). The decision follows a futility review by an Independent Data Monitoring Committee (IDMC) that concluded the trials were unlikely to meet the primary endpoint of proptosis response at week 24.
The IDMC’s recommendation was based on interim data that showed a low probability of achieving the pre‑specified threshold for proptosis improvement. Efgartigimod had maintained a favorable safety and tolerability profile, with no new safety signals identified, but the lack of efficacy data made continued investment untenable.
Argenx’s Q3 2025 financial results provide context for the decision. The company reported record product net sales of $1.13 billion, driven largely by VYVGART sales that exceeded $1 billion for the first time in a quarter. Cash and cash equivalents stood at $4.3 billion, giving the company a strong balance sheet to support its core pipeline and strategic priorities.
Chief Medical Officer Luc Truyen said the IDMC’s futility analysis was a planned part of the study design and that the decision reflects disciplined resource management. CEO Tim Van Hauwermeiren added that the company remains focused on its “bold innovation agenda” and will continue to advance efgartigimod in its approved indications of generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
In pre‑market trading, Argenx shares fell more than 6 percent, a reaction that investors attributed to the loss of a potential new indication and the associated revenue opportunity. The decline underscores the market’s sensitivity to Phase 3 trial outcomes, even when a company’s core business remains strong.
The discontinuation aligns with Argenx’s Vision 2030 strategy, which prioritizes core autoimmune indications and aims to advance five pipeline candidates into Phase 3 by 2030. By reallocating resources from the TED program, Argenx can accelerate development in its high‑potential areas and maintain a robust pipeline while preserving its substantial cash reserves.
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