Both BioPharma Dive and STAT report that Argenx's blockbuster drug Vyvgart failed to beat placebo in a Phase 3 trial for Sjögren's disease, a chronic autoimmune condition with no approved disease-modifying treatments. The two outlets differ slightly on the market reaction: BioPharma Dive says shares fell 15% on Thursday, while STAT puts the morning decline at 13%. BioPharma Dive adds that an independent monitoring board recommended ending the trial for futility, and that the timing caught analysts off guard because results were not expected until the second half of 2027.
BioPharma Dive provides additional context that STAT's paywalled article does not. The company also announced positive Phase 2 results for FB102, a celiac disease drug acquired through its $2.2 billion takeover of Forte Biosciences, but that news failed to offset investor concerns. Analysts quoted by BioPharma Dive noted that Sjögren's success could have added up to $1.4 billion in peak sales, though many had not modeled the indication because of its risk. The failure removes another expansion opportunity for the Vyvgart franchise, which already generates billions in quarterly sales.
Despite the setback, some analysts remain optimistic. William Blair's Matt Phipps wrote that Argenx's premium valuation has historically made Phase 3 pullbacks buying opportunities, and TD Securities' Yaron Werber viewed the celiac data as derisking a second franchise. The broader competitive landscape is also shifting, as BioPharma Dive notes that Novartis and Amgen have both reported successful Phase 3 trials in Sjögren's disease.