AMGN · News · 20260923N
Product Pipeline Progress
AMGEN INC · 2026-09-23 · Importance 34 · Surprise 42 · In source text
Amgen’s dazodalibep met the primary endpoint in the Phase 3 OASIZ 301 trial for systemic Sjögren’s disease, demonstrating improved systemic disease activity. The company did not disclose the treatment difference versus placebo, p-values, or confidence intervals, limiting independent assessment of the benefit magnitude. A second Phase 3 study, OASIZ 303, is expected to conclude in late 2026 and is evaluating patients with high symptom burden but low systemic activity. Jefferies raised its risk-adjusted peak-sales estimate for dazodalibep to $4.5 billion following the results.
Key facts
- A second Phase 3 study (OASIZ 303) is expected to conclude in late 2026 and will focus on patients with high symptom burden but low systemic activity. source
- Amgen reported that its Phase 3 Sjögren's disease trial for dazodalibep (OASIZ 301) met its primary endpoint showing an improvement in systemic disease activity. source
- Amgen did not disclose the treatment difference against placebo or specific data like p-values or confidence intervals for OASIZ 301. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | unclear | contingent | — | A second Phase 3 study (OASIZ 303) is expected to conclude in late 2026 and will focus on patients with high symptom burden but low… |