Amgen (AMGN) Stock Pops 4% as Sjögren’s Drug Could Be First of Its Kind

TLDR

• Amgen stock jumped roughly 4% in premarket trading Tuesday after positive Phase 3 trial results for dazodalibep in Sjögren’s disease
• The OASIZ 301 study met its primary endpoint, showing statistically meaningful improvement in systemic disease activity at Week 48
• Improvements were seen as early as Week 4 and held through the full 48-week study period
• There are currently no FDA-approved treatments for Sjögren’s disease, making dazodalibep a potential first-in-class therapy
• Amgen plans to present full data at an upcoming medical conference; a second Phase 3 study is expected to complete in Q4 2026

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Amgen (AMGN) stock jumped roughly 4% in premarket trading Tuesday, hitting $406.02 just after the open, after the company reported positive topline results from a Phase 3 trial of its experimental Sjögren’s disease drug, dazodalibep.

Amgen Inc., AMGN

The trial, called OASIZ 301, met its primary endpoint. Patients showed statistically meaningful improvement in systemic disease activity at Week 48, measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).

The move pushed AMGN back above its 50-day moving average.

The study enrolled around 621 patients with moderate-to-severe systemic Sjögren’s disease. Results showed improvements as early as Week 4, and those gains held through the end of the 48-week period.

Sjögren’s is a systemic autoimmune disease that causes dryness, fatigue, chronic pain, and can affect major organs. There are currently no FDA-approved medicines for the condition.

That gap in the market is a key part of the story here. If dazodalibep clears regulatory review, it would be the first approved treatment for Sjögren’s.

What Makes Dazodalibep Different

Dazodalibep is a CD40L antagonist fusion protein. It works by disrupting the interactions between T cells, B cells, and other immune cells that drive the disease.

Jay Bradner, Amgen’s head of research and development, said the speed and durability of the results reinforced the company’s confidence in the drug and its broader Phase 3 program.

The most common side effects in the trial were nasopharyngitis, urinary tract infections, hypertension, and infusion-related reactions. Most were mild to moderate. Discontinuation rates due to side effects were low and similar across the treatment and placebo groups.

Competitive Landscape

Amgen is not alone in this space. Novartis (NVS) is also developing a Sjögren’s treatment called ianalumab, which works differently by targeting the BAFF protein.

Ianalumab showed 1.3- to 1-point improvements over placebo on a 42-point symptom scale in its trial. Leerink Partners analyst David Risinger said it is likely to win approval in the coming months.

Risinger rates AMGN stock a market perform.

Amgen plans to present full data from OASIZ 301 at an upcoming medical conference. The detailed readout will give investors a clearer picture of how dazodalibep stacks up against ianalumab.

A second Phase 3 study, OASIZ 303, is looking at dazodalibep in patients with moderate-to-severe symptomatic Sjögren’s disease. That study is expected to wrap up in Q4 2026.