Amgen's Dazodalibep Shows Promise in Treating Systemic Sjögren’s Disease

Amgen's experimental autoimmune drug dazodalibep has shown promise in treating systemic Sjögren’s disease, an autoimmune illness that affects moisture-producing glands and can spread to joints, nerves, and major organs. In a late-stage study, the medication produced statistically significant and clinically meaningful improvements on a standard score of how the disease affects organs and systems.

The trial, known as OASIZ 301, enrolled about 621 adults with moderate-to-severe systemic Sjögren’s disease. After 48 weeks, dazodalibep showed gains in disease intensity as early as week 4 and lasted throughout the study. Side effects were generally mild to moderate, but colds, urinary tract infections, higher blood pressure, and infusion reactions were more common with the drug than with a placebo.

Amgen acquired dazodalibep through its 2023 purchase of Horizon Therapeutics. A second late-stage study in patients with heavy symptoms but lower systemic activity is expected to finish in the fourth quarter. Citigroup has expressed cautious optimism, stating that while the results are positive, the magnitude of efficacy and competitive profile 'remain open questions' until more data are presented.

Shares of Amgen (AMGN) rallied 4% after the announcement, with some investors reacting positively to the company's first late-stage win for a potential systemic treatment in Sjögren’s disease. However, AMGN stock has already gained 25% year-to-date, and Citigroup maintains a Neutral rating and $405 price target on Amgen shares.