ZURICH, Jan 17, 2026, 18:33 CET — Market closed.
- Novartis AG’s shares listed in the U.S. climbed 0.8% on Friday, closing at $144.34
- Company announced the FDA has given Breakthrough Therapy designation to ianalumab for treating Sjögren’s disease
- Attention shifts to Novartis earnings on Feb. 4, as U.S. markets will be closed Monday
Novartis AG (NVS) shares ended Friday on a positive note after the Swiss pharma giant revealed that U.S. regulators awarded fast-track designation to its ianalumab programme. This move brings immunology back into focus ahead of the company’s earnings report. 1
The FDA’s Breakthrough Therapy designation is designed to accelerate the development and review of drugs targeting serious conditions, provided early clinical data points to a significant improvement over current treatments. 2
The timing is key since Novartis will report its quarterly and full-year results on Feb. 4. That date usually reshuffles expectations around pipeline priorities, launch expenses, and upcoming catalysts. 3
Novartis announced that ianalumab has received breakthrough therapy designation for Sjögren’s disease. The company aims to start global approval filings in early 2026. Angelika Jahreis, Novartis’s global head of immunology development, said the designation “recognizes the potential” of ianalumab to fill a gap where patients “currently don’t have effective treatment options.” 4
Ianalumab is a monoclonal antibody aimed at depleting B-cells and blocking BAFF-R, a key pathway in B-cell activation and survival, the company said. Its late-stage programme features Phase 3 trials targeting patients with active disease. 5
Sjögren’s is a chronic autoimmune disorder impacting various organs, commonly causing intense dryness, fatigue, and pain. Patient advocates argue the FDA’s decision underscores the scarcity of approved and effective treatments for many living with the disease. 6
The designation doesn’t equal approval. Novartis still faces a full regulatory review, which could be delayed if safety concerns arise or regulators demand additional data.
Trading won’t be smooth. U.S. markets shut on Monday for Martin Luther King Jr. Day, so Novartis’s ADRs won’t see normal action until Tuesday. 7
Investors will be looking closely for follow-through on filings and whether Novartis outlines a clear path to launch or anticipates a prolonged regulatory process as it plans its 2026 budgets.
The next major event arrives on Feb. 4, when Novartis will face questions about the filing plan for ianalumab and its potential to boost growth beyond the existing portfolio.
