AMGN · News · 20260922N

Product / Drug Pipeline Progress

AMGEN INC · 2026-09-22 · Importance 31 · Surprise 42

Amgen reported positive topline Phase 3 OASIZ 301 results for dazodalibep in adults with moderate-to-severe systemic Sjögren’s disease. The CD40L antagonist met its primary endpoint, producing statistically significant and clinically meaningful improvements in systemic disease activity, with rapid and sustained effects. Sjögren’s disease currently has no FDA-approved systemic therapies, giving dazodalibep potential first-in-class positioning in an underserved autoimmune market. Amgen expects the separate Phase 3 OASIZ 303 study to complete in late 2026 before discussing regulatory filing plans.

Key facts

• Amgen plans to present detailed data from the OASIZ 301 study at an upcoming medical meeting. source
• Another Phase 3 study, OASIZ 303, is expected to complete in late 2026. source
• Amgen expects to await data from another Phase 3 study (OASIZ 303), projected to conclude in Q4 2026, before discussing regulatory approval. source
• Amgen announced positive topline results from its Phase 3 OASIZ 301 study for dazodalibep in adults with moderate-to-severe systemic Sjögren's disease, meeting its primary endpoint with statistically significant and clinically meaningful improvement in systemic disease activity. source
• Dazodalibep demonstrated rapid and sustained improvements in systemic disease activity in the Phase 3 OASIZ 301 study. source
• There are currently no FDA-approved medicines for Sjögren’s disease. source