Argenx discontinues Vyvgart study in Sjögren's disease, shares tumble

Argenx's stock dropped over 14% premarket after halting a late-stage trial for an injectable form of Vyvgart, intended for Sjögren's disease treatment.

Argenx shares dropped 16% after halting a Phase 3 trial of efgartigimod for Sjögren’s disease due to unlikely success. The independent committee recommended stopping the study as it wouldn't meet the primary endpoint. The company plans to analyze the data further. Efgartigimod is approved for other conditions in Japan.

argenx SE (ARGX) stock fell 15.7% to €707.4 after terminating its Phase 3 UNITY study for efgartigimod in Sjögren’s disease due to failure to meet the primary endpoint. The company also reported positive Phase 2 results for its FB102 asset in celiac disease, but this did not offset the decline. The broader market and biotech sector were also under pressure.

Argenx reported positive Phase 2 results for FB102 in celiac disease, meeting its primary endpoint. The company will advance FB102 into Phase 3. Separately, argenx discontinued the Phase 3 UNITY study of efgartigimod in Sjögren's disease due to futility. Shares fell 7.91% overnight.

Argenx SE reported that its FB102 antibody met the primary endpoint in a Phase 2 celiac disease trial, showing statistically significant improvement over placebo. The company plans to advance the drug into Phase 3 development. Argenx's shares closed at US$928.44 on Wednesday, prior to the announcement. The trial measured intestinal damage, and the company noted a consistent safety profile. Argenx reported US$1.5 billion in Q2 product sales and US$472 million in profit.

argenx (ARGX) halted its Phase 3 UNITY trial for efgartigimod in Sjögren’s disease after the IDMC recommended stopping due to futility. The trial failed to meet its primary endpoint, though safety results aligned with expectations. The company will analyze data for future research. Efgartigimod is approved for other autoimmune diseases.