Amgen's Dazodalibep Shows Promising Results in Phase 3 Trial

Amgen's stock price surged over 4% in premarket trading after positive Phase 3 trial results for its experimental Sjögren’s disease drug, dazodalibep. The OASIZ 301 study met its primary endpoint, showing statistically meaningful improvement in systemic disease activity at Week 48.

The study enrolled around 621 patients with moderate-to-severe systemic Sjögren’s disease and demonstrated improvements as early as Week 4, which held through the full 48-week study period. This milestone marks a significant step forward for Amgen, as dazodalibep could become the first FDA-approved treatment for Sjögren’s disease.

Amgen plans to present full data from OASIZ 301 at an upcoming medical conference and is also conducting a second Phase 3 study, OASIZ 303, which is expected to complete in Q4 2026. The results of these studies will provide further insight into the efficacy and safety of dazodalibep compared to other treatments in development.