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argenx Provides Update on Phase 3 UNITY Study of Efgartigimod SC in Sjögren's Disease
An independent monitoring board said the study was unlikely to meet its main goal, and Argenx shares fell 16%, wiping out €8.5 billion in value.
On Thursday, Argenx discontinued its late-stage Phase 3 study of Vyvgart in adults with Sjögren's disease, an autoimmune condition that damages moisture-producing glands, after an interim analysis deemed the trial futile.
An independent monitoring board recommended ending the study "for futility" after concluding the drug was unlikely to meet its primary efficacy endpoint, despite Sjögren's having no approved treatments.
Shares fell 16% on Thursday, wiping $9.5 billion from Argenx's market value, though the biotech still maintains a market cap of around $50 billion.
William Blair analyst Matt Phipps noted the failure removes a "blockbuster expansion opportunity" for Vyvgart, while competitors Novartis and Amgen reported successful late-stage trial results for the condition.
Investors are now focusing on pipeline assets like a celiac disease treatment acquired through Argenx's $2.2 billion takeover of Forte Biosciences, for which analyst Yaron Werber models $988 million in peak sales.