Amgen's dazodalibep Secures Phase III Success in Sjögren's Disease, Sending Stock Higher

AMGN reported that dazodalibep met the primary endpoint of the Phase 3 OASIZ 301 trial in moderate-to-severe systemic Sjögren's disease, showing a statistically significant and clinically meaningful improvement at Week 48 on the EULAR Sjögren's Syndrome Disease Activity Index. The study randomised roughly 621 patients with ESSDAI scores of 5 or higher, and improvement was observed as early as Week 4 and sustained through Week 48. Sjögren's has no approved systemic disease-modifying therapy, which is why the result carries more weight than a single-trial readout usually would.

The market reaction was immediate. AMGN traded up 4.3% at $410.24 on SentiSense data, with contemporaneous reports describing a premarket move of about 4% and an intraday high of $407 against a prior reference of $393.16. SentiSense sentiment on the name reads +0.71 latest against a +0.22 thirty-day average, a 2.7 sigma anomaly relative to its own recent baseline. This is a company-specific move rather than a sector one, so read it as a repricing of Amgen's pipeline, not as biotech strength.

The regulatory path is the part the headlines understate. Amgen has a second Phase 3 study, OASIZ 303, examining dazodalibep in patients with moderate-to-severe symptomatic Sjögren's, projected to conclude in the fourth quarter of 2026. Analysts covering the readout have generally treated that second trial as necessary before a filing is realistic, so today's win advances the programme rather than completing it. Amgen's release did disclose adverse-event data, describing events as mild to moderate with balanced discontinuations and no imbalance in clotting or infection.

Two details are worth holding lightly. Enrollment is reported as roughly 621 patients in Amgen's own release and as 651 in some secondary coverage, a discrepancy we could not resolve. And Novartis's ianalumab is working the same indication on a similar timeline, so first-to-market is a contested claim rather than a settled one. What to watch: the OASIZ 303 readout in the fourth quarter, the full data presentation at a medical meeting, and the filing timeline Amgen guides to once both studies are in hand.