Global Finance News
22 Sep 2026, 18:40
Amgen Stock Jumps 4% After Positive Phase 3 Dazodalibep Results in Sjögren’s Disease
Amgen shares rose 4% to $408.88 after the company reported positive topline results from the Phase 3 OASIZ 301 study of dazodalibep in adults with moderate-to-severe systemic Sjögren’s disease.
The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in systemic disease activity at Week 48, measured by the ESSDAI score. Amgen said improvement was visible as early as Week 4 and was sustained through Week 48.
The result is notable because there are currently no FDA-approved medicines specifically for Sjögren’s disease, creating a potentially significant commercial opportunity if dazodalibep ultimately reaches the market. The drug is designed as a CD40L antagonist fusion protein that disrupts immune-cell interactions involved in disease activity.
Safety findings were broadly manageable, with the most common adverse events including nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions. Amgen said treatment discontinuations due to adverse events were low and balanced across study groups.
The company plans to present detailed OASIZ 301 data at an upcoming medical meeting, while the separate Phase 3 OASIZ 303 study is expected to complete in the fourth quarter of 2026.
Amgen shares rose 4% to $408.88 after the company reported positive topline results from the Phase 3 OASIZ 301 study of dazodalibep in adults with moderate-to-severe systemic Sjögren’s disease.
The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in systemic disease activity at Week 48, measured by the ESSDAI score. Amgen said improvement was visible as early as Week 4 and was sustained through Week 48.
The result is notable because there are currently no FDA-approved medicines specifically for Sjögren’s disease, creating a potentially significant commercial opportunity if dazodalibep ultimately reaches the market. The drug is designed as a CD40L antagonist fusion protein that disrupts immune-cell interactions involved in disease activity.
Safety findings were broadly manageable, with the most common adverse events including nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions. Amgen said treatment discontinuations due to adverse events were low and balanced across study groups.
The company plans to present detailed OASIZ 301 data at an upcoming medical meeting, while the separate Phase 3 OASIZ 303 study is expected to complete in the fourth quarter of 2026.
