Amgen Shares Rise on Positive Phase 3 Data for Sjögren's Disease Drug

Amgen Inc. (NASDAQ:AMGN) shares climbed 4% in premarket trading on Tuesday after the company reported positive topline results from a late-stage study of its experimental drug, dazodalibep, for treating Sjögren’s disease.

Trial Meets Primary Endpoint

Amgen announced that its Phase 3 OASIZ 301 study successfully met its primary endpoint. The trial demonstrated a statistically significant and clinically meaningful improvement in systemic disease activity at Week 48, as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).

The study, which enrolled approximately 621 patients with moderate-to-severe systemic disease activity, showed that improvements began as early as Week 4 and were sustained throughout the 48-week period. Amgen plans to present detailed data from the trial at an upcoming medical meeting.

Addressing an Unmet Need

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Sjögren’s disease is a chronic systemic autoimmune disorder that can affect the entire body, causing symptoms like extensive dryness, fatigue, and major organ damage. Crucially for investors, there are currently no FDA-approved medicines specifically for the condition, representing a significant unmet medical need.

Dazodalibep is a potential first-in-class CD40L antagonist designed to disrupt the immune cell interactions that drive the disease. According to Amgen, the most common adverse events in the trial were generally mild to moderate, and discontinuations due to side effects were low.

Outlook and Next Steps

The positive data represents a key milestone in the drug's development pipeline. A second Phase 3 study, OASIZ 303, which is evaluating dazodalibep in patients with moderate-to-severe symptomatic Sjögren’s disease, is expected to be completed in the fourth quarter of 2026, according to the company.