Novartis scores a Phase 3 win in Sjögren’s syndrome, salvaging value from its $2.9B MorphoSys buy

Novartis’ Ianalumab met primary endpoints in two Phase 3 trials for Sjögren’s syndrome, showing statistically significant improvement in disease activity versus placebo, with a favorable safety profile.

Why it matters: If approved, ianalumab could become the first targeted therapy for Sjögren’s syndrome. Its statistical data shows signs of improvement in patients taking ianalumab versus those taking the placebo. Sjögren’s syndrome is a chronic autoimmune disease affecting multiple organs and causing dry eyes, dry mouth, joint pain, fatigue, and systemic complications. There is currently no disease-modifying treatment available and many drug candidates have already failed late-stage testing.

Backstory:

• Novartis acquired MorphoSys in 2024 for $2.9B, mainly for a cancer drug, pelabresib, whose approval timeline has been delayed until at least 2027.

• Ianalumab, part of the deal, had been under joint development for autoimmune diseases targeting malfunctioning B cells.

• While it failed in hidradenitis suppurativa, Novartis remained confident in its potential for other conditions.

Big picture: Ianalumab targets B cells by marking them for destruction and blocking BAFF-R, a receptor essential for their survival. If approved, ianalumab could transform the treatment landscape, becoming the first disease-modifying option and strengthening Novartis’ autoimmune portfolio while salvaging value from Novartis’ costly MorphoSys acquisition.

What’s next: Novartis will present full trial data at an upcoming medical conference and submit to global regulators.