Argenyx announced that its drug Vyvgart did not meet the main goals in a Phase III clinical trial for thyroid eye disease (TED). This market had been seen as a potential $550 million opportunity for the company. Following an interim analysis, an independent data monitoring committee advised stopping the UplighTED studies because they were unlikely to succeed.
The company stated it will further analyze the data to guide future research in TED and plans to present additional findings at upcoming medical meetings.
In a note to clients, William Blair analysts described the failure as unexpected. They pointed out that Vyvgart, part of the FcRn inhibitor class, had previously shown success in treating Graves disease—a related condition. The analysts noted, “the news raises questions about the biological differences between the two diseases.” They added that TED could have contributed approximately $550 million in sales for Vyvgart, which is already approved for generalized myasthenia gravis.
Despite this setback, Argenyx is moving forward with efforts to expand Vyvgart into other indications. Ongoing trials include myositis and Sjögren’s disease, both of which showed positive results in earlier Phase II studies. William Blair expressed particular confidence in these two indications.
The company also plans to continue its Phase III study of Vyvgart in Graves disease. However, William Blair observed that “today’s news makes that trial a riskier bet.”
This development benefits Amgen, whose drug Tepezza is currently approved for TED and has generated $1.45 billion in sales during the first nine months of 2025. Viridian is waiting for FDA approval of veligrotug—an IGF-1R antagonist—for TED next year.
“For Viridian, we think the removal of another potential competitor is obviously a positive, and this would seem to raise questions about the potential for the FcRn class in this indication,” wrote William Blair.
Immunovant’s anti-FcRn agent batoclimab remains under clinical evaluation with results expected during the first half of next year.
BioSpace issued a correction noting: “An earlier edition of this story said that veligrotug is an FcRb inhibitor. It is an IGF-1R antagonist. BioSpace regrets the error.”
