argenx Provides Update on UplighTED Studies of Efgartigimod SC in Thyroid Eye Disease
Rhea-AI Summary
argenx (NASDAQ: ARGX) announced on December 15, 2025 that the Phase 3 UplighTED studies of efgartigimod SC in adults with moderate-to-severe thyroid eye disease (TED) will be discontinued after an Independent Data Monitoring Committee recommended stopping for futility following a pre-specified interim analysis.
The IDMC reviewed unblinded data from patients completing 24 weeks. Efgartigimod showed a favorable safety and tolerability profile with no new safety signals. Argenx will close out the studies, lock the databases, and perform a comprehensive analysis; data will be shared at a future medical meeting.
Positive
- IDMC identified no new safety signals in Phase 3 data
- Efgartigimod demonstrated a favorable tolerability profile
Negative
- Phase 3 UplighTED studies discontinued for futility after interim review
- Primary endpoint at week 24 was not met per IDMC recommendation
Key Figures
Market Reality Check
Peers on Argus
Peers show mixed, mostly modest moves (e.g., REGN -0.04%, ALNY -2.77%, VRTX +1.63%), suggesting this TED trial discontinuation is company-specific rather than a sector-wide biotech move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 18 | Governance update | Positive | -0.4% | Remuneration policy approved with high shareholder support at EGM. |
| Oct 30 | Earnings report | Positive | -0.2% | Strong Q3 2025 revenue, profit, and reaffirmed expense guidance. |
| Oct 29 | Clinical data update | Positive | -1.7% | VYVGART Phase 3 and real-world gMG data showed meaningful benefit. |
| Oct 23 | Earnings preview | Neutral | -0.2% | Announcement of timing and access details for Q3 2025 results call. |
| Oct 15 | Conference preview | Positive | +0.3% | Planned presentation of >40 abstracts on VYVGART and pipeline assets. |
Recent history shows a pattern of flat-to-negative price reactions even on seemingly positive corporate, financial, and clinical updates.
Over the last few months, argenx reported strong Q3 2025 results with operating income of $1.15 billion and profit of $344 million, while maintaining a cash position of $4.3 billion. It also highlighted positive VYVGART clinical data and broad immunology innovation at major neuromuscular meetings. Governance actions, such as approval of the updated remuneration policy with 95.67% of votes in favor, and routine 6-K filings complemented this growth story. Despite these constructive updates, share reactions around prior news often skewed slightly negative, framing today’s TED futility discontinuation against an otherwise solid backdrop.
Market Pulse Summary
This announcement details the IDMC-recommended discontinuation of the Phase 3 UplighTED studies in thyroid eye disease after a 24-week futility analysis, while confirming a favorable safety and tolerability profile for subcutaneous efgartigimod. It follows a period of strong financial performance and positive data in other indications. Investors may focus on how this affects the breadth of the efgartigimod franchise, the company’s future research priorities in TED, and upcoming registrational milestones.
Key Terms
independent data monitoring committee medical
pharmacokinetics medical
pharmacodynamics medical
immunogenicity medical
AI-generated analysis. Not financial advice.
15 December, 2025, 7:00 AM CET
Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the Phase 3 UplighTED studies evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate to severe thyroid eye disease (TED) will be discontinued.
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. Importantly, efgartigimod showed a favorable safety and tolerability profile, and no new safety signals were identified.
“We are disappointed the studies did not meet our desired outcome and we especially empathize with patients who are living with TED and seeking new therapies for this challenging disease,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. “We had pre-planned this futility analysis as it provides a meaningful interim evaluation of observed patient outcomes and enables us to responsibly evaluate the study’s future likelihood of success. This approach is fundamental to our disciplined and responsible stewardship of investment and resources in our clinical development programs. We are deeply grateful to the TED community and all those who contributed to these studies.”
The IDMC conducted a futility evaluation of unblinded data from patients completing 24 weeks in the Phase 3 studies. Following close out and database lock, argenx will conduct a comprehensive analysis of the data to enhance understanding of the studies’ outcomes and uncover key biological insights that may inform future research in TED. Data from the studies will be shared at a future medical meeting.
UplighTED Study Design
The Phase 3 randomized, double-masked, placebo-controlled, multicenter studies are designed to evaluate the efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of efgartigimod PH20 SC administered by prefilled syringe in adult participants with thyroid eye disease. Enrolled participants have active, moderate-to-severe thyroid eye disease associated with autoimmune thyroid conditions (Graves' disease or Hashimoto's thyroiditis). Patients were randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period. The primary endpoint is measured as the percentage of participants who were proptosis responders at week 24. Key secondary endpoints include change in proptosis measurement in the study eye from baseline up to week 24, change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline up to week 24, and percentage of participants with resolution of diplopia at week 24.
About Thyroid Eye Disease (TED)
Thyroid Eye Disease (TED) is an autoimmune orbital disease associated with Graves’ disease and other autoimmune thyroid pathologies such as Hashimoto’s thyroiditis. TED is characterized by extraocular muscle enlargement, orbital adipose tissue expansion, and orbital inflammation, which can lead to proptosis, diplopia, or vision loss in severe cases. Persistent orbital symptoms often impair patient quality of life. In the active phase, swelling and protrusion can cause pain and may affect vision. In the inactive phase, some symptoms may improve; however, protrusion and double vision may persist.
About VYVGART and VYVGART SC
VYVGART® (efgartigimod alfa fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and for primary immune thrombocytopenia (ITP) in Japan. VYVGART SC is a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. It is marketed as VYVGART® Hytrulo in the U.S., VYVGART SC in Europe, VYVDURA® in Japan, and may be marketed under different proprietary names following approval in other regions.
This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube.
Media:
Colin McBean
cmcbean@argenx.com
Investors:
Alexandra Roy
aroy@argenx.com
Forward Looking Statements
The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “aim,” “committed,” “may,” “plan,” and “will” and include statements argenx makes concerning its future analysis of the data from the Phase 3 UplighTED studies to enhance understanding of the studies’ outcomes and uncover key biological insights that may inform future research in TED; the sharing of the data from the Phase 3 UplighTED studies at a future medical meeting; its commitment to improving the lives of people suffering from severe autoimmune diseases; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx’s clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.
FAQ
Why did argenx (ARGX) stop the Phase 3 UplighTED studies on December 15, 2025?
Did efgartigimod SC show safety concerns in the UplighTED Phase 3 trials (ARGX)?
What was the primary endpoint for argenx's UplighTED Phase 3 trials (ARGX)?
Will argenx share UplighTED study data from the discontinued Phase 3 trials (ARGX)?
What are the key secondary endpoints in argenx's UplighTED studies (ARGX)?
