Amgen’s Sjögren’s drug phase three data update: Both dosing regimens meet primary endpoint, with improvement in dryness symptoms

What do the new phase three trial data show?

In patients with Sjögren’s syndrome and moderate to severe systemic disease activity, both intravenous dazodalibep regimens met the primary endpoint at week 48: ESSDAI scores, which measure disease activity, fell by an additional 1.8 and 1.4 points, respectively, versus placebo.
The score fell by 5.6 points from baseline in the group receiving 1500 milligrams every four weeks, by 5.2 points in the group receiving 3000 milligrams every 12 weeks, and by 3.8 points in the placebo group; patients’ average score at enrollment was 10.2 points. The treatment effect appeared as early as week four.

The improvement in patient-reported dryness symptoms was statistically significant in the group dosed every four weeks. ESSPRI dryness scores fell by 2.50 points from baseline, versus 1.33 points in the placebo group; scores on another measure, DASPRI dryness, fell by 1.98 and 1.05 points, respectively.
Rates of treatment-emergent adverse events, serious adverse events and adverse events leading to treatment discontinuation were similar across treatment groups. Morgan Stanley is also awaiting more detailed data on safety, fatigue and joint counts, among other measures, to be disclosed at the conference.

In two phase three trials of Novartis’s ianalumab, monthly subcutaneous injections reduced ESSDAI scores by an additional 1.3 and 1.0 points, respectively, versus placebo at week 48, but there were no significant differences in patient-reported dryness or symptom diary scores.
The primary endpoint was statistically significant for both dazodalibep dosing regimens, and dosing every four weeks also improved patient-reported dryness symptoms. However, cross-trial comparisons have limitations: ESSDAI fell by 3.8 points in the placebo group in Amgen’s trial, and by 5.1 and 5.5 points, respectively, in the placebo groups of the two Novartis trials.

Amgen plans to present more data at the American College of Rheumatology meeting on 11 November; data from another phase three trial, OASIZ-303, in patients with moderate to severe symptomatic Sjögren’s syndrome are expected before the end of 2026.
Morgan Stanley’s model assigns the program a 65% probability of success and forecasts risk-adjusted sales of 1.2 billion US dollars in 2035. The bank rates Amgen Equal-weight with a price target of 359 US dollars; the closing price on 26 October 2026 listed in the report was 444.63 US dollars.