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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 unlikely to meet its primary endpoint.
An independent monitoring board recommended ending the study "for futility" after concluding the drug was unlikely to meet its primary efficacy endpoint, noting Sjögren's currently has no approved treatments.
Argenx shares fell 16% on Thursday, wiping $9.5 billion from market value, though the biotech maintains a market cap of around $50 billion even after the decline.
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 Argenx's pipeline assets, including a celiac disease treatment acquired through the $2.2 billion Forte Biosciences takeover, for which analyst Yaron Werber models $988 million in peak sales.