Positive new Phase III data for Amgen’s dazodalibep

Amgen's dazodalipeb showed positive results in a Phase III trial for Sjögren’s disease, meeting primary endpoints with significant improvements in disease activity and symptoms. The drug was acquired via Amgen's 2023 takeover of Horizon Pharma. Analysts suggest it may have advantages over competitors like Novartis' ianalumab. Amgen plans to continue Phase III trials. Sjögren’s disease affects around 4 million people in the US.

Amgen reported positive Phase 3 results for dazodalibep, a treatment for Sjögren’s disease, from the OASIZ-301 study. The company plans to present full results at ACR Convergence 2026.

Amgen (AMGN) reported that its experimental drug dazodalibep met the primary endpoint in a Phase 3 trial for Sjögren's disease, showing significant reductions in disease activity. Both dosing regimens showed improvements in patient-reported symptoms and safety. The company plans to continue Phase 3 development, but no regulatory timeline was provided.

Amgen presented phase 3 trial results for dazodalibep in Sjögren's disease, showing both dosing schedules reduced systemic disease activity more than placebo. Novartis awaits an FDA decision on rival ianalumab. Amgen's second phase 3 trial, OASIZ-303, is ongoing. No FDA-approved therapies exist for Sjögren's, an autoimmune disease.

Amgen's dazodalibep met primary endpoints in Phase 3 OASIZ-301 trial for Sjögren’s disease, reducing systemic disease activity vs. placebo. Both dosing regimens showed significant ESSDAI score improvements. Results will be presented at ACR Convergence 2026. Amgen plans further Phase 3 studies.

Amgen's shares declined in premarket trading after presenting full Phase 3 trial results for dazodalibep, its Sjögren's disease therapy. The trial met its primary endpoint, with 1,500 mg and 3,000 mg doses showing ESSDAI score reductions of 5.6 and 5.2 points, respectively, over 48 weeks. The 1,500 mg dose also improved patient-reported dryness, a key secondary endpoint.