Amgen reported preliminary Phase 3 success for dazodalibep in Sjögren’s disease, setting up a potential first targeted therapy for a condition that currently has no approved treatments. The fusion protein achieved statistically significant and clinically meaningful results in the study, according to the company’s update. The readout also positions dazodalibep against established competitors in the autoimmune space and raises the odds of an FDA review milestone for a first-in-class mechanism. Amgen’s Sjögren’s pipeline momentum is tied to the broader Horizon Therapeutics acquisition, under which dazodalibep was acquired. Investors and clinicians will now watch for the next late-stage trial results and for what endpoints will be prioritized in regulatory discussions, as Sjögren’s becomes a key autoimmune proving ground for immunomodulatory biologics.