Amgen, US0311621009

Amgen stock advances as dazodalibep Phase 3 results expand pipeline case

Published on 11/11/2026 at 15:45 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS
Amgen stock gets a new Phase 3 update as dazodalibep shows clinically meaningful benefits in Sjögren's disease. Further development remains ahead.

Fresh clinical evidence for Amgen

  • Amgen reported positive Phase 3 results for dazodalibep in patients with Sjögren's disease.
  • The OASIZ-301 findings showed statistically significant reductions in systemic disease activity versus placebo.
  • Further Phase 3 development and regulatory progress remain important next steps for the investigational medicine.
Amgen, US0311621009, Illustration mit AI erstellt.

Amgen reported new Phase 3 results for dazodalibep in Sjögren's disease on Wednesday, November 11, strengthening the clinical profile of an investigational pipeline medicine. The results were carried by PR Newswire via Yahoo Finance.

Phase 3 results broaden the case

In the randomized OASIZ-301 study, both tested dosing schedules met the primary endpoint at Week 48. The least-squares mean ESSDAI score fell by 5.6 points with 1,500 milligrams every four weeks and by 5.2 points with 3,000 milligrams every 12 weeks, compared with a 3.8-point decline for placebo.

The placebo-adjusted differences were 1.8 points for the monthly regimen and 1.4 points for the quarterly regimen. Amgen said treatment effects appeared as early as Week 4 and remained evident through Week 48.

Dryness and safety remain in focus

The monthly regimen also improved patient-reported dryness. The placebo-adjusted least-squares mean differences were 1.17 points on the ESSPRI dryness domain and 0.93 points on the DASPRI dryness domain, with adjusted p-values below 0.001 for both measures.

Serious adverse events and treatment discontinuations were balanced across the treatment groups, according to the release. The company said common adverse events included nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions, generally at mild-to-moderate severity.

Development path remains ahead

Dazodalibep is an investigational CD40L antagonist being developed for two Sjögren's disease populations. Amgen is also conducting the Phase 3 OASIZ-303 study in patients with high symptom burden and low systemic disease activity, while OASIZ-304 is evaluating longer-term safety and tolerability.

Amgen stock traded at 416.80 euros on Lang & Schwarz at 15:35 CET on Wednesday, November 11, 2026.

Amgen Inc. stock facts

  • Company: Amgen Inc.
  • ISIN: US0311621009
  • Ticker: AMGN
  • Home exchange: Nasdaq
  • Lang & Schwarz price: 416.80 euros at 15:35 CET on November 11, 2026

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