Amgen Hits Primary Endpoint In Sjögren's Trial, But Approval Filing Awaits Another Trial Data - Amgen (NA
Amgen (AMGN) reported positive results from its Phase 3 OASIZ 301 trial for dazodalibep in treating Sjögren’s disease, meeting the primary endpoint. The study showed statistically significant improvements in disease activity scores. Adverse events were low and similar to placebo. Amgen plans to share full data at a future conference and awaits results from another trial, OASIZ 303, for potential FDA filing. Shares rose 3.54% to $407.08. Analysts expect two positive trials for approval.
How this was made
The 30-second read
Why it matters
Meeting the primary endpoint at 48 weeks with early onset (Week 4) is a meaningful efficacy signal, but the filing timeline remains contingent on OASIZ 303 completion projected for Q4 2026.
Market read
Traders can reassess AMGN’s Sjögren’s program probability-weighting after a positive Phase 3 primary endpoint readout, while keeping an eye on the next Phase 3 data catalyst.
What to watch
The article provides topline efficacy and general safety, but traders may still discount the result without details on effect size durability, subgroup consistency, and any regulatory concerns that could emerge from full data at a conference.
Background
Dazodalibep is being evaluated in Sjögren’s disease via Phase 3 OASIZ 301 and OASIZ 303; the program is framed as higher risk due to historical placebo response and patient heterogeneity.
Ticker impact
Amgen reported Phase 3 OASIZ 301 met its primary endpoint in Sjögren’s, with statistically significant ESSDAI improvement at 48 weeks and Week 4 onset.
Near-term upside bias versus peers on continued Sjögren’s program momentum; volatility likely around the upcoming OASIZ 303 Q4 2026 readout.
The article is a first disclosure of topline Phase 3 efficacy meeting the primary endpoint, while explicitly stating a second Phase 3 study is still needed before an approval filing.
Market effects
Reinforces investor appetite for autoimmune immunology assets with credible Phase 3 efficacy signals despite historically high placebo response risk in Sjögren’s.
Limited direct regional spillover; primarily US biotech sentiment.
Moderate, as Sjögren’s trial outcomes can influence global autoimmune development expectations and competitive positioning.
Counterpoint
A single Phase 3 success may not translate into approval odds if OASIZ 303 fails to replicate efficacy or if regulators discount the magnitude/consistency of ESSDAI improvements.
Key entities
- companyAmgen Inc.
Reported topline Phase 3 OASIZ 301 results for dazodalibep in Sjögren’s, including statistically significant ESSDAI improvement at 48 weeks.
- drugdazodalibep
Investigational therapy evaluated in Phase 3 OASIZ 301 and OASIZ 303 for Sjögren’s disease.
- clinical_trialOASIZ 301
Phase 3 study whose primary endpoint was met at 48 weeks using ESSDAI.
- clinical_trialOASIZ 303
Phase 3 study projected to conclude in Q4 2026, expected to inform regulatory filing discussions.
