Amgen stock: Dazodalibep Phase 3 trial meets key endpoints

Amgen reported positive Phase 3 results for dazodalibep in Sjogren's disease on Wednesday, November 11, 2026. The OASIZ-301 study met its primary endpoint with both tested dosing regimens, adding a new clinical development milestone for the biotechnology company. The findings were released ahead of a late-breaking presentation at the American College of Rheumatology Convergence 2026.

Amgen's release said the randomized, placebo-controlled trial enrolled 648 patients with moderate-to-severe systemic disease activity. At Week 48, the 1,500-milligram dose given every four weeks reduced the ESSDAI systemic disease activity score by 5.6 points from baseline, compared with 3.8 points for placebo. The 3,000-milligram dose given every 12 weeks reduced the score by 5.2 points, also versus 3.8 points for placebo.

Clinical data broaden the pipeline case

The placebo-adjusted difference was 1.8 points for the monthly regimen and 1.4 points for the 12-week regimen. Amgen said treatment effects appeared as early as Week 4 and continued through Week 48. The monthly regimen also produced statistically significant improvements in patient-reported dryness on two disease-specific measures.

The data remain clinical-stage evidence rather than an approved treatment. Amgen said it is conducting additional Phase 3 work in patients with high symptom burden and lower systemic disease activity, while a long-term extension study is evaluating safety and tolerability. Investors will therefore focus on further clinical readouts and the regulatory path.

Amgen stock traded at 422.73 euros on Lang & Schwarz at 15:36 CET on Thursday, November 12, 2026.

US biotechnology shares remain sensitive to clinical milestones and regulatory timelines; the S&P 500 market backdrop provides the broader equity context.

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