Amgen delivered a positive late-stage clinical update on September 22, with its experimental drug dazodalibep meeting the primary goal in a Phase 3 study of Sjögren’s disease. The result adds momentum to Amgen’s drug-development pipeline at a time when pharmaceutical investors are closely watching late-stage assets that could expand revenue beyond the company’s existing portfolio.

Dazodalibep Clears a Key Phase 3 Hurdle

The OASIZ 301 study evaluated dazodalibep in adults with moderate-to-severe systemic Sjögren’s disease. After 48 weeks, treatment produced a statistically significant and clinically meaningful improvement in disease activity, measured using the EULAR Sjögren’s Syndrome Disease Activity Index, or ESSDAI. Improvements were observed as early as Week 4 and were sustained through Week 48.

Sjögren’s disease is a systemic autoimmune condition that can cause extensive dryness of the eyes, mouth and other parts of the body, as well as fatigue and chronic pain. It affects about 1% of the global population and predominantly affects women. There are currently no FDA-approved medicines specifically for Sjögren’s disease in the United States.

Market Reaction Reflects Pipeline Importance

Amgen shares rose as much as 4% in morning trading following the announcement, reflecting the significance investors place on successful late-stage development programs. The company generated $10.1 billion in second-quarter 2026 revenue, up 10% from a year earlier, while 22 products delivered double-digit sales growth.

The Sjögren’s result therefore does not immediately change Amgen’s financial profile, but it strengthens the potential contribution of its development pipeline over time. Dazodalibep is a potential first-in-class CD40L antagonist fusion protein designed to interfere with immune activation involving T cells, B cells and other antigen-presenting cells.

Competition and the Next Clinical Test

The positive OASIZ 301 result does not yet establish regulatory approval. Novartis and Johnson & Johnson are also developing treatments for Sjögren’s disease, and investors will need to compare Amgen’s full results with competing clinical data, including Novartis’ ianalumab.

Amgen is also testing dazodalibep in OASIZ 303, a separate Phase 3 study involving patients with moderate-to-severe symptom burden and lower systemic disease activity. Results are expected in the fourth quarter of 2026. Amgen plans to present detailed OASIZ 301 data at an upcoming medical meeting, providing investors with a clearer view of the drug’s efficacy and safety profile.

Attention will now turn to the OASIZ 303 results, the detailed Phase 3 data and Amgen’s potential regulatory filing strategy. The key questions will be whether the second study confirms the first trial’s findings, how dazodalibep compares with competing treatments and whether the program can ultimately become a meaningful commercial asset for Amgen.