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Amgen Dazodalibep Trial Met Primary Endpoint

The Phase 3 OASIZ 301 study of dazodalibep in systemic Sjögren's disease patients met its primary endpoint at Week 48.

Updated on Sept. 22, 2026 in Corporate Finance

Isometric editorial illustration of a single medical test vial on a sterile surface, representing clinical trial progress.
Amgen reported that its Phase 3 OASIZ 301 study for the drug dazodalibep reached its primary endpoint in patients with systemic Sjögren's disease. AI Illustration. Upload story photo >

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Amgen announced that its Phase 3 OASIZ 301 trial successfully met its primary endpoint for treating moderate-to-severe systemic Sjögren's disease. The trial evaluated disease activity improvement using the ESSDAI scale after 48 weeks of treatment.

Why it matters

Currently, there is no treatment approved specifically for systemic Sjögren's disease activity, making this clinical success a significant milestone for patients. Amgen's positive trial results come after the company previously discontinued a different candidate for the condition.

Amgen shares saw activity following the announcement, with a short-volume ratio of 0.676 recorded on 18 September and 0.582 on 21 September. The company reported $10,054 million in quarterly revenue and $2,375 million in net income as of 30 June 2026.

The players

Amgen

Amgen is a multinational biotechnology company that focuses on developing human therapeutics for serious illnesses.

Horizon Therapeutics

Horizon Therapeutics is a biopharmaceutical company that was acquired by Amgen in 2023 to expand its portfolio of rare disease treatments.

The details

The OASIZ 301 trial tested the efficacy of dazodalibep against a placebo across 651 participants with systemic Sjögren's disease. Researchers tracked the change from baseline in ESSDAI scores to measure the drug's impact on systemic disease activity over a 48-week period.

Timeline

  1. Amgen acquired Horizon Therapeutics in 2023.

  2. The company recorded $7,447 million in revenue during Q1 2024.

  3. Fiscal results for the quarter ending 30 June 2026 showed $10,054 million in revenue.

  4. On 18 September 2026, the short-volume ratio reached 0.676.

  5. Amgen officially announced the dazodalibep trial results on 22 September 2026.

Market Dynamics

This development follows the successful completion of the OASIZ 301 trial, setting a clear trajectory for the upcoming OASIZ 303 Phase 3 trial. These clinical milestones reflect Amgen's broader strategy of pivoting its R&D efforts after the discontinuation of previous Sjögren's candidates.

The clinical milestone may influence short-term stock performance, as evidenced by recent shifts in short-volume ratios leading up to the announcement. Investors should monitor how these trial results impact the company's long-term earnings and diluted earnings per share metrics.

The takeaway

The successful trial represents a breakthrough for patients suffering from systemic Sjögren's disease who currently lack approved treatment options. This success underscores the importance of continued investment in orphan drug research to fill critical gaps in the medical market.

What happens next

Amgen expects to complete the OASIZ 303 Phase 3 trial in the fourth quarter of 2026.

Further reading

For more information on the company's financial operations, visit the Corporate Finance section.

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Do you trust pharmaceutical companies to successfully bring needed new specialty drugs to market?