Amgen says Phase 3 OASIZ 301 trial meets primary endpoint for dazodalibep in systemic Sjögren's disease

Bitget2026/09/22 13:06

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Amgen reported positive topline Phase 3 OASIZ 301 results for dazodalibep in moderate-to-severe systemic Sjögren's disease.
Trial met the primary endpoint, showing a statistically significant, clinically meaningful ESSDAI improvement at Week 48 versus placebo.
ESSDAI benefit emerged by Week 4, then held through Week 48, supporting differentiation in a disease with no FDA-approved medicines.
Safety profile showed mostly mild-to-moderate adverse events; discontinuations were low and balanced, with no thromboembolic or opportunistic infection imbalance.
Detailed data will be presented at a medical meeting; Phase 3 OASIZ 303 is expected to complete in Q4 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amgen Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202609220900PR_NEWS_USPR_____LA53425) on September 22, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Amgen says Phase 3 OASIZ 301 trial meets primary endpoint for dazodalibep in systemic Sjögren's disease

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