SWX:NOVNPharmaceuticals
Will FDA Breakthrough Status For Ianalumab In Sjögren’s Disease Change Novartis' (SWX:NOVN) Narrative
In mid-January 2026, Novartis reported that the US FDA granted Breakthrough Therapy designation to ianalumab for Sjögren’s disease, a fully human monoclonal antibody with a dual B‑cell and BAFF‑R blockade mechanism supported by positive replicate Phase III data.
This move positions ianalumab as a potential first targeted therapy in a condition with no approved targeted treatments, highlighting Novartis’s growing focus on complex autoimmune diseases and late-stage specialty medicines.
We’ll...