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benzinga Corporate Catalyst Impact 75/100 ● positive

Amgen Announces Its Phase 3 OASIZ 301 Trial Of Dazodalibep To Treat Sjogren's Disease Meets Primary Endpoint, Shows Improvement In Systemic Disease Activity At Week 48

Sep 22, 2026, 1:02 PM UTC · Primary ticker $AMGN

Amgen announced positive topline results from its Phase 3 OASIZ 301 study for dazodalibep in Sjögren's disease, meeting its primary endpoint with statistically significant and clinically meaningful improvement. This positive trial outcome suggests a potential new treatment option for a disease with limited therapies, which could significantly impact Amgen's future revenue streams.

Amgen announced that its Phase 3 OASIZ 301 trial for dazodalibep, targeting Sjögren's disease, successfully met its primary endpoint. This is a significant development as it indicates the drug's efficacy in improving systemic disease activity, as measured by the ESSDAI, a validated clinical tool. This positive outcome is a major catalyst for Amgen, potentially leading to regulatory submissions and commercialization, which could open up a new revenue stream in a market with unmet medical needs. For traders, this presents a short-term opportunity for Amgen's stock to rise due to increased investor confidence in its pipeline, with long-term implications for its market share in autoimmune disease treatments. The key opportunity lies in the potential for dazodalibep to become a leading therapy for Sjögren's disease.

$AMGN positive Successful Phase 3 trial
Source: benzinga
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