Amgen reported preliminary Phase 3 success for dazodalibep in Sjögren’s disease, setting up an FDA review that could potentially make it the first therapy for a condition with no approved drugs. The company said the fusion protein achieved statistically significant and clinically meaningful results in late-stage testing. Separately, Celldex reported Phase 3 wins for chronic skin hives, while Gen. Celldex’s pipeline update also reflected how safety signals and efficacy outcomes remain tightly linked in dermatology immunology development. These updates reinforce late-stage momentum in immune-driven diseases—where differentiation depends on both endpoint performance and tolerability as companies compete to fill treatment gaps.