Amgen shares rose as much as 5% after the biotechnology company reported positive topline results from OASIZ 301, the first of two Phase 3 trials testing investigational therapy dazodalibep in moderate-to-severe systemic Sjögren’s disease. The study met its primary goal, showing statistically significant and clinically meaningful improvement in disease activity at 48 weeks on the EULAR Sjögren’s Syndrome Disease Activity Index, or ESSDAI. Benefits appeared by Week 4 and continued throughout the evaluation period. Following the results, Amgen’s stock price target was raised to $410. Amgen did not disclose detailed efficacy results, which it plans to present at a future medical meeting. Investigators found no imbalance in blood clots or opportunistic infections, potential safety concerns associated with dazodalibep’s mechanism. Side effects were generally mild to moderate, and discontinuations were infrequent and balanced across study groups. Sjögren’s is a systemic autoimmune disorder in which the immune system attacks moisture-producing glands, causing dry eyes and mouth, pain, inflammation and other complications; patients also face a higher risk of lymphoma. No approved treatments currently alter the disease’s course. Dazodalibep blocks the CD40-CD40L signaling pathway between immune cells, an approach intended to reduce abnormal immune activity and tissue-damaging autoantibodies. The drug originated at AstraZeneca, was spun out into Viela Bio, acquired by Horizon Therapeutics in 2021 and later became part of Amgen through its acquisition of Horizon two years afterward. Amgen’s second pivotal study, involving patients with a high symptom burden, is expected to report data in the fourth quarter; the companion OASIZ 303 study is projected to conclude in the fourth quarter of 2026. Analysts said the detailed OASIZ 301 results will help assess dazodalibep against Novartis’ ianalumab, which could be cleared by regulators this quarter, while Bristol Myers Squibb is expected to report Phase 3 results for its marketed psoriasis drug Sotyktu in Sjögren’s. Both Amgen Phase 3 studies involve distinct patient populations, and analysts said the company needs positive results in both for regulatory approval.