Amgen stock advances dazodalibep case with Phase 3 data

Amgen reported positive Phase 3 results for dazodalibep in Sjögren's disease on Wednesday, November 11, 2026. The company's announcement said both dosing regimens in the OASIZ-301 study achieved the primary endpoint at Week 48, reducing systemic disease activity more than placebo.

Two dosing regimens meet endpoint

OASIZ-301 enrolled 648 patients with moderate-to-severe systemic disease activity. Participants had a mean baseline score of 10.2 on the European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index, or ESSDAI.

The 1,500-milligram regimen administered every four weeks produced a least-squares mean ESSDAI reduction of 5.6 points from baseline, compared with 3.8 points for placebo. The placebo-adjusted difference was 1.8 points, with an adjusted p-value below 0.001. The 3,000-milligram regimen administered every 12 weeks reduced ESSDAI by 5.2 points, producing a 1.4-point advantage over placebo and an adjusted p-value of 0.010.

Amgen said treatment effects appeared as early as Week 4 and continued through Week 48. The findings were presented in a late-breaking session at the American College of Rheumatology Convergence 2026.

Dryness benefit adds differentiation

The monthly regimen also improved patient-reported dryness, a central symptom of Sjögren's disease. Compared with placebo, the placebo-adjusted least-squares mean difference was -1.17 points on the dryness domain of the EULAR Sjögren's Syndrome Patient Reported Index and -0.93 points on the corresponding Diary for Assessing Sjögren's Patient Reported Index measure. Both results had adjusted p-values below 0.001.

Additional analyses favored dazodalibep on total symptom scores, clinically meaningful ESSDAI responses and the Sjögren's Tool for Assessing Response. Patients receiving the drug also showed greater increases in stimulated salivary flow, an objective measure of oral dryness.

Safety remains part of the case

The most common adverse events reported more often with dazodalibep than placebo included nasopharyngitis, urinary tract infections, hypertension and infusion-related reactions. Amgen described these events as generally mild to moderate. Serious adverse events and discontinuations caused by adverse events were balanced across the three treatment groups.

The company also reported no imbalance in thromboembolic events or opportunistic infections, while malignancy rates were low and comparable across groups. For investors, the safety profile is important because CD40L-directed approaches have faced clotting concerns in earlier development programs.

Amgen stock and investor context

Amgen stock traded at 426.08 euros on Lang & Schwarz at 13:07 CET on Thursday, November 12, 2026.

Investors can follow the broader US equity backdrop in the S&P 500 market overview.

Further developments around the clinical program and Amgen stock are collected in More news and analyses on Amgen stock.