Key Highlights

  • On November 11, 2026, Amgen (NASDAQ:AMGN) released detailed late-stage dazodalibep findings in Sjogren's disease.
  • By week 48, disease activity scores improved 5.6 points on 1,500 mg every four weeks and 5.2 points on 3,000 mg every 12 weeks, compared with 3.8 points for placebo.
  • Each comparison reached statistical significance, and the every-four-week schedule also produced a significant gain in patient-reported dryness.
  • Adverse event rates were comparable across arms, and a second Phase 3 trial, OASIZ 303, is due to finish in the fourth quarter of 2026.

Findings From the Trial

Sjogren's disease is a chronic autoimmune illness in which the immune system targets the glands that make tears and saliva. It brings severe dryness, fatigue and joint pain and, for some patients, harm to the lungs, kidneys and nerves. For years, care has centred on easing symptoms instead of altering the disease course. Dazodalibep blocks CD40 ligand, a signal that helps T cells switch on B cells, the cells behind the antibody production at the heart of the condition. Over 48 weeks, both the monthly and the quarterly regimen from Amgen (NASDAQ:AMGN) lowered systemic disease activity by more than placebo. The dryness result on the every-four-week dose carries weight, since dryness is what patients feel most, and earlier candidates often shifted physician-rated scores without changing daily life. That record helps explain why many programmes have failed despite a large patient pool and strong commercial interest.

The Strategic Case for Amgen

The drug joined Amgen through its purchase of Horizon Therapeutics, a deal built on rare and autoimmune disease medicines. Millions of people worldwide live with Sjogren's disease, many of them women, so a disease-modifying therapy could grow into a major product if approved. The timing matters because the company is working to offset Patent expiries on older products. Third-quarter 2026 Revenue reached USD 10.4 billion, up 8%, and full-year guidance sits at USD 38.9 billion to USD 39.7 billion. Immunology, cardiovascular disease and obesity are expected to carry growth into the next decade. A quarterly schedule would also be a practical benefit for patients already juggling several medicines and frequent clinic visits. Rheumatologists, who usually treat the condition, already know Amgen from its existing inflammatory disease portfolio. Canadian investors who hold the stock through a domestic brokerage account can follow the same milestones.

Rivals and Upcoming Milestones

Several large drugmakers are testing treatments aimed at B cells, antibody recycling and other immune pathways, so Amgen will not be alone in this space. Early approvals are likely to set the standard for efficacy, convenience and safety. A placebo response of 3.8 points shows how hard the disease is to study, and regulators will examine whether benefit is consistent across both Phase 3 trials. For Amgen (NASDAQ:AMGN), the key dates are the finish of OASIZ 303 later this quarter and any filing decision in 2027, plus how physicians compare monthly and quarterly dosing. Complete publication, including fatigue and other patient-reported outcomes, will also shape medical opinion. If the second study succeeds, dazodalibep would rank among the more advanced late-stage Assets in the company's immunology portfolio.

Where Things Stand

Dazodalibep lowered Sjogren's disease activity by 5.6 and 5.2 points across its two regimens, against 3.8 points on placebo at week 48, with comparable side effect rates. The second Phase 3 trial should finish in the fourth quarter of 2026. Positive data from both studies would support a filing in a field with high unmet need and growing competition. For Amgen, it is one of several pipeline programmes that will determine growth once older products lose exclusivity.