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Amgen's Dazodalibep Hits Phase 3 Primary Endpoint in Sjogrens Disease Trial
Read this in the Market Flux appAmgen Inc. $AMGN
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Amgen reported positive top-line results from its Phase 3 OASIZ 301 trial of dazodalibep in patients with moderate-to-severe systemic Sjogren's disease, a chronic autoimmune condition that attacks moisture-producing glands and currently has no FDA-approved treatment. The trial enrolled approximately 621 patients and met its primary endpoint based on the ESSDAI disease activity score at Week 48, with meaningful reductions in disease activity observed as early as Week 4 and sustained throughout the study period.
The result positions dazodalibep as a potential first-ever approved therapy for Sjogren's disease, though a regulatory filing is not yet imminent. Amgen is awaiting data from a second Phase 3 study, OASIZ 303, which focuses on symptomatic Sjogren's disease and is expected to complete in the fourth quarter of 2026.
Amgen shares rose roughly 2% in premarket trading and were among the largest midday movers on Wall Street, as reported by CNBC. The stock outperformed broader market competitors on the day, according to MarketWatch.
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Sources
- ReutersAmgen's autoimmune drug succeeds in late-stage trial
- reuters.comAmgen's autoimmune drug succeeds in late-stage trial
- TheTradeXchange$AMGN AMGN - AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR DAZODALIBEP IN MODERATE-TO-SEVERE SYSTEMIC SJÖGREN'S DISEASE
- OpenOutcrier$AMGN (+2.0% pre) AMGN Reports Phase 3 dazodalibep data in Sjögren's disease; Primary endpoint met at Week 48
- Wallstengine$AMGN PHASE 3 SJÖGREN’S TRIAL HITS PRIMARY ENDPOINT Amgen says dazodalibep significantly improved systemic disease activity in patients with moderate-to-severe Sjögren’s disease, with benefits seen as early as Week 4 and sustained through Week 48. The Phase 3 OASIZ 301 trial enrolled about 621 patients and met its primary endpoint based on the ESSDAI disease activity score. There are currently no FDA-approved medicines for Sjögren’s disease. A second Phase 3 study, OASIZ 303, focused on symptomatic Sjögren’s, is expected to complete in Q4.
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