Dazodalibep (HZN-4920) - (OASIZ 301)

Sept. 22, 2026: Amgen (NASDAQ: AMGN) reported positive topline Phase 3 results from OASIZ 301 for dazodalibep in adults with Sjögren’s disease and moderate-to-severe systemic disease activity. The trial met its primary endpoint, showing statistically significant and clinically meaningful improvement versus placebo at Week 48 on ESSDAI, with improvement observed as early as Week 4 and sustained through Week 48.

Safety: the most common adverse events occurring at a higher rate than placebo (at least 5%) were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions; these were generally mild to moderate. Discontinuations due to adverse events were low and balanced across groups, and no imbalance was seen in thromboembolic events or opportunistic infections.

OASIZ 301 is a randomized, double-blind, placebo-controlled Phase 3 study in patients with ESSDAI at least 5, with approximately 621 participants. Key secondary endpoints included dryness, tender and swollen joints, fatigue, and ESSDAI response of at least a 5-point reduction.

Upcoming catalysts: Amgen plans to present detailed OASIZ 301 data at an upcoming medical meeting. The Phase 3 OASIZ 303 study in symptomatic Sjögren’s disease with high symptom burden and low systemic disease activity is expected to complete in Q4 2026.