Amgen stock: ACR abstract details dazodalibep Phase 3 results
Published on 11/11/2026 at 13:03 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWSClinical data supports pipeline outlook
- OASIZ-301 met its primary endpoint at Week 48 in adults with moderate-to-severe Sjogren's disease.
- Monthly dazodalibep dosing also improved patient-reported dryness compared with placebo.
- The treatment's safety profile was similar across the study groups.
Amgen stock is in focus on Wednesday, November 11, as detailed Phase 3 results for dazodalibep in Sjogren's disease are scheduled for presentation at ACR Convergence 2026. The ACR Meeting Abstracts page lists the late-breaking oral session for 8:45 to 9:00 a.m. Eastern Time.
The OASIZ-301 trial evaluated dazodalibep in adults with moderate-to-severe systemic Sjogren's disease. The randomized, double-blind, placebo-controlled study followed patients for 48 weeks and assigned 648 participants to monthly dazodalibep, quarterly dazodalibep or placebo. The primary endpoint was the change in systemic disease activity measured by the ESSDAI scale at Week 48.
Primary endpoint shows treatment benefit
Both dosing schedules produced statistically significant improvements compared with placebo. The least-squares mean ESSDAI change was minus 5.6 points with 1,500 milligrams every four weeks and minus 5.2 points with 3,000 milligrams every 12 weeks. The placebo group recorded a minus 3.8-point change. The adjusted differences versus placebo were minus 1.8 points for monthly dosing and minus 1.4 points for quarterly dosing, with adjusted p-values below 0.001 and 0.010, respectively.
The abstract says a treatment effect was visible as early as Week 4. That timing may matter for the commercial prospects of dazodalibep, although the program remains investigational and the abstract does not establish a regulatory approval path or launch date.
Dryness data adds secondary support
Monthly dosing also improved patient-reported dryness, a key secondary endpoint. The ESSPRI dryness score changed by minus 2.50 points with dazodalibep versus minus 1.33 points with placebo. On the DASPRI measure, the respective changes were minus 1.98 and minus 1.05 points. Both comparisons had adjusted p-values below 0.001.
The ACR abstract reports similar rates of treatment-emergent adverse events, serious adverse events and treatment-emergent adverse events leading to discontinuation across the treatment groups. For investors, the data strengthen a potential autoimmune pipeline asset, while longer-term development, safety monitoring and regulatory progress remain important next steps.
Amgen stock traded at 414.98 euros on Lang & Schwarz at 13:00 CET on Wednesday, November 11, 2026.
Amgen stock at a glance
- Company: Amgen Inc.
- ISIN: US0311621009
- Ticker: AMGN
- Latest quote: 414.98 euros on Lang & Schwarz, November 11, 2026, 13:00 CET
U.S. equity-market conditions provide the broader backdrop for Amgen stock through the S&P 500.
Further clinical updates and company developments are collected on the Amgen stock news and analysis page.
