Amgen Drug Met Phase 3 Endpoint for Sjögren's Disease

The drugmaker's trial success for a previously untreatable condition could shift its long-term growth profile.

Updated on Sept. 22, 2026 in Corporate Finance

Bold vector editorial illustration showing a precision glass medical vial, representing pharmaceutical clinical research. — Amgen announced that its Phase 3 clinical trial for the drug dazodalibep successfully met primary endpoints in treating systemic Sjögren's disease. AI Illustration. Upload story photo >

Live Poll

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

Amgen's Phase 3 OASIZ 301 trial met its primary endpoint for treating systemic Sjögren's disease. The study evaluated dazodalibep in 651 patients with moderate-to-severe disease activity, potentially filling a major therapeutic gap.

Why it matters

The successful trial represents a strategic win for Amgen’s pipeline following the 2023 acquisition of Horizon Therapeutics. Validating this asset provides a potential path to market in an area where no specific treatments are currently approved.

The OASIZ 301 trial enrolled 651 participants to measure ESSDAI scale improvements at Week 48. This follows Amgen’s quarterly revenue of $10,054 million for the period ending 30 June 2026, up from $7,447 million in Q1 2024.

The players

Amgen

A multinational biotechnology company focused on human therapeutics, with a large-scale R&D pipeline.

Horizon Therapeutics

A biopharmaceutical company acquired by Amgen in 2023 to expand its portfolio of rare disease treatments.

The details

The trial measured change from baseline in ESSDAI scores after 48 weeks of dazodalibep treatment compared to a placebo. Amgen acquired the candidate through its 2023 purchase of Horizon Therapeutics, repurposing the asset after previously discontinuing a different Sjögren's candidate named AMG 329. The results offer potential competitive differentiation for the firm, which reported $2,375 million in net income for the quarter ending 30 June 2026.

2023: Amgen acquired Horizon Therapeutics.
30 June 2026: Amgen's most recent fiscal quarter ended.
18 September 2026: The AMGN short-volume ratio reached 0.676.
22 September 2026: Amgen announced the OASIZ 301 trial results.

Market Landscape

This development follows Amgen's 2023 acquisition of Horizon Therapeutics, which significantly shifted the firm's focus toward rare disease therapeutics. The successful clinical result validates the integration of this acquired asset into Amgen's broader R&D strategy.

Operators in the biotechnology and pharmaceutical sectors should monitor this outcome as a signal of successful asset integration post-acquisition. Investors and managers should track the upcoming OASIZ 303 trial completion in Q4 2026 to gauge the long-term commercial potential for this program.

The takeaway

Amgen’s clinical success underscores the value of strategic portfolio acquisitions in overcoming R&D hurdles for rare diseases. Operators should review the upcoming Q4 2026 completion of the OASIZ 303 trial as a key indicator of continued progress for this therapeutic candidate.