Amgen's Dazodalibep Wins Phase 3 Trial in Unserved Sjögren's Disease

Amgen Inc. (NASDAQ:AMGN) has made significant progress in its immunology pipeline with the success of dazodalibep in a large phase 3 trial for moderate-to-severe systemic Sjögren's disease.

Sjögren's disease is a chronic autoimmune condition, and Amgen states there are currently no FDA-approved medicines for it. The OASIZ 301 study, which involved approximately 621 adults with an ESSDAI score of at least five, met its primary endpoint by showing a statistically significant and clinically meaningful improvement in disease activity.

The trial demonstrated that dazodalibep, a potential first-in-class CD40L antagonist fusion protein, was effective in reducing disease activity as early as week four and sustained through week 48. The most common adverse events were mild to moderate and included nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions.

Amgen reported second-quarter total revenues of $10.1 billion, up 10% year on year, with product sales of $9.54 billion, up 9%. The company raised its 2026 guidance to revenues of $38.2 billion to $39.4 billion and guides to GAAP earnings per share of $15.80 to $17.08.