Amgen Hits Primary Endpoint In Sjögren's Trial, But Approval Filing Awaits Another Trial Data
Key takeaways
- Amgen’s Phase 3 trial hit its primary goal, but a second positive study is still needed before FDA filing.
- 48 weeks primary endpoint
- ESSDAI mean reduction 4.5 vs 1.2
- p<0.01
What happened
Amgen Inc. (NASDAQ: AMGN) announced that its Phase 3 OASIZ 301 study of dazodalibep met its primary endpoint, showing a statistically significant and clinically meaningful improvement in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) at 48 weeks. The benefit appeared as early as week 4 and was sustained through week 48. Adverse event rates were similar to placebo, with no excess thromboembolic events or opportunistic infections. Amgen plans to present full data at a future…
Why it matters
The positive primary endpoint in a Phase 3 trial is a critical milestone for a drug that has faced high placebo response rates and patient heterogeneity in Sjögren’s disease (SjD). Meeting the ESSDAI target suggests the drug can meaningfully reduce systemic disease activity, a key therapeutic gap. However, regulatory…
Short-term and longer-term
Short-term. For traders, the key watch is the upcoming OASIZ 303 readout in Q4 2026, which could confirm the drug’s efficacy and trigger a filing.
Longer-term. From an investor perspective, the OASIZ 301 result validates Amgen’s strategy to tackle a high‑need autoimmune disease.