Amgen's Dazodalibep Hits Primary Endpoint in Phase 3 Sjögren's Trial — Amgen Inc.

Event summary

Amgen's Phase 3 OASIZ 301 study of dazodalibep in moderate-to-severe Sjögren's disease met its primary endpoint, showing statistically significant improvement in ESSDAI score at Week 48.
Improvements in systemic disease activity were observed as early as Week 4 and sustained through Week 48.
Dazodalibep is a potential first-in-class CD40L antagonist fusion protein designed to disrupt immune activation.
The Phase 3 OASIZ 303 study in symptomatic Sjögren's disease is expected to complete in Q4 2026.

The big picture

Amgen's positive Phase 3 results for dazodalibep mark a significant step toward addressing the unmet need in Sjögren's disease, a condition with no approved systemic treatments. The success of this trial could position Amgen as a leader in autoimmune disease therapeutics, particularly if the drug gains regulatory approval and demonstrates sustained efficacy in broader patient populations. The broader biotech sector will be watching closely, as this could set a precedent for developing treatments for other rare autoimmune conditions.

What we're watching

Regulatory Pathway: Whether Amgen can secure FDA approval for dazodalibep, given the lack of current treatments for Sjögren's disease.
Market Differentiation: How dazodalibep's first-in-class status will position Amgen in the competitive landscape of autoimmune disease treatments.
Clinical Validation: The pace at which additional Phase 3 studies (OASIZ 303 and OASIZ 304) will provide further evidence of dazodalibep's efficacy and safety.