Amgen stock: Dazodalibep meets both Phase 3 Sjogren's endpoints
Published on 11/13/2026 at 13:24 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWSDazodalibep clears key clinical hurdle
- Amgen said both OASIZ-301 dosing regimens reduced systemic disease activity more than placebo.
- The four-week regimen also improved patient-reported dryness and stimulated salivary flow.
- Further development includes Phase 3 studies for different Sjogren's disease patient groups.
Amgen announced positive Phase 3 results for its investigational treatment dazodalibep on Wednesday, November 11, 2026. In the randomized OASIZ-301 study, both tested dosing regimens met the primary endpoint after 48 weeks, according to the Amgen investor release.
Two regimens beat placebo
OASIZ-301 enrolled 648 patients with moderate-to-severe systemic disease activity. The mean baseline score on the ESSDAI measure was 10.2, with the primary endpoint defined as the change from baseline after 48 weeks.
The 1,500-milligram regimen given every four weeks produced a least-squares mean ESSDAI reduction of 5.6 points, compared with 3.8 points for placebo. The placebo-adjusted difference was 1.8 points, with an adjusted p-value below 0.001. The 3,000-milligram regimen administered every 12 weeks reduced ESSDAI by 5.2 points, versus 3.8 points for placebo. Its placebo-adjusted difference was 1.4 points, with an adjusted p-value of 0.010.
Amgen said treatment effects appeared as early as Week 4 and continued through Week 48. The company described the findings as support for dazodalibep's potential as a first-in-class CD40L antagonist fusion protein, but the treatment remains investigational and is not approved by the U.S. Food and Drug Administration.
Dryness benefit adds to case
The four-week regimen also improved patient-reported dryness, a key symptom of Sjogren's disease. Compared with placebo, the regimen delivered placebo-adjusted improvements of 1.17 points on the dryness domain of the ESSPRI scale and 0.93 points on the DASPRI dryness domain. Both comparisons had adjusted p-values below 0.001.
Additional analyses favored dazodalibep on total ESSPRI and DASPRI scores, with mean improvement in total ESSPRI exceeding 1.5 points for both dosing regimens. Amgen also reported greater increases in stimulated salivary flow and higher proportions of patients meeting STAR response criteria, a composite measure covering patient-reported symptoms and objective disease activity.
Safety and development remain central
The most common adverse events occurring more frequently with dazodalibep than placebo included nasopharyngitis, urinary tract infections, hypertension and infusion-related reactions. Amgen said these events were generally mild to moderate. Serious adverse events and discontinuations because of adverse events were balanced across the treatment groups, while no imbalance in thromboembolic events or opportunistic infections was observed.
For investors, the results strengthen the clinical rationale for a late-stage pipeline asset in an area where Amgen says no U.S.-approved therapies currently exist. They do not remove the usual development and regulatory risks: the trial results must support later regulatory discussions, and a successful Phase 3 study does not guarantee approval or commercialization.
Amgen stock traded at 425.25 euros on Lang & Schwarz at 13:17 CET on Friday, November 13, 2026.
Amgen Inc.
- ISIN: US0311621009
- Ticker: AMGN
- Home listing: Nasdaq
- Latest Lang & Schwarz quote: 425.25 euros, Friday, November 13, 2026, 13:17 CET
- Sector: Healthcare
- Index membership: Dow Jones Industrial Average and Nasdaq-100
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Amgen is also advancing OASIZ-303 for patients with high symptom burden and low systemic disease activity, alongside the long-term extension study OASIZ-304. More news and analyses on Amgen stock.
