Amgen quarterly results show Sjögren’s improvement, Japanese TEPEZZA success and 128% IMDELLTRA growth

Key Facts

In results published on November 3, Amgen said its Phase 3 OASIZ-301 study of dazodalibep met its primary endpoint in adults with moderate to severe systemic activity from Sjögren’s syndrome. The study measured the primary endpoint at week 48 using the ESSDAI disease activity index, and was a randomized, double-blind, placebo-controlled trial involving about 621 patients. The company had announced the initial positive result in September, while its third-quarter update included detailed study results. Amgen said the change from baseline in ESSDAI was 5.6 points with dosing every four weeks and 5.2 points with dosing every 12 weeks. After accounting for the placebo effect, improvement was 1.8 points and 1.4 points, respectively.

Improvements also appeared in patient-reported dryness measures at week 48. The change from baseline was 2.50 points on the ESSPRI dryness scale, with a placebo-adjusted improvement of 1.17 points. On the DASPRI dryness scale, the change was 1.98 points and the adjusted improvement was 0.93 points. The company said dazodalibep’s clinical effect was evident from week four and that its safety profile was favorable and similar across treatment groups. The study defines an ESSDAI response as a reduction of at least 5 points from baseline, while its secondary endpoints include dryness, joint pain and swelling, and fatigue.

Amgen said the Sjögren’s results address an area that currently lacks drugs approved by the U.S. Food and Drug Administration. The company did not announce approval of dazodalibep in these results; the data relate to a clinical study and its findings. Amgen is scheduled to present OASIZ-301 data at the ACR Convergence conference on November 11, during a session from 8:45 to 9:00 a.m. Eastern time. The company is also continuing the Phase 3 OASIZ 303 study in Sjögren’s patients with moderate to severe symptomatic burden and low systemic activity. Amgen expects the study to be completed in the fourth quarter of 2026.

In the same third-quarter update, Amgen said its Phase 3 Chronic-J study of TEPEZZA in Japanese patients with chronic thyroid eye disease met both primary endpoints. It added that the study’s safety profile was consistent with the drug’s known profile. Commercially, TEPEZZA sales fell 6% year over year to $526 million in the third quarter. The company attributed the decline to lower inventory levels, according to its quarterly results. The update thus combines the Japanese study result with sales performance for the same period, with different implications for each.

IMDELLTRA sales, meanwhile, rose 128% year over year to $406 million in the third quarter, with Amgen saying sales volume growth drove the increase. The company also said the FDA approved an update to the drug’s prescribing information in September, shortening the recommended monitoring period after the first two doses. The period is now 6–8 hours from the start of infusion, down from 22–24 hours previously. Approval of the monitoring change came in September, while the third-quarter results included the update in the company’s business review. The two drugs’ sales trajectories diverged during the quarter: strong growth for IMDELLTRA versus a TEPEZZA decline attributed to inventory.

At the company level, total third-quarter revenue rose 8% from the same period in 2025 to $10.4 billion. Adjusted non-GAAP earnings per share also increased 14%, from $5.64 to $6.45. Chief Executive Robert Bradway said the strength of the commercial product portfolio, clinical progress and late-stage pipeline bolstered the company’s confidence in its ability to deliver sustainable growth through the next decade. The results place the trial data within a quarterly report that recorded growth in revenue and earnings per share, alongside mixed sales performance for the two drugs cited. The next milestone for the Sjögren’s program is the presentation of OASIZ-301 data on November 11, followed by the expected completion of OASIZ 303 in the fourth quarter of 2026.