NVS Stock Rises After FDA Grants Breakthrough Therapy Designation For Autoimmune Disorder Treatment

Novartis looks to submit data from its many trials of Ianalumab with health authorities starting in early 2026 for potential approval.

Shares of Novartis (NVS) rose 1% on Friday after the U.S. Food and Drug Administration granted its drug Ianalumab a breakthrough therapy designation in the treatment of Sjögren’s disease.

Novartis looks to submit data from its many trials of Ianalumab with health authorities starting in early 2026 for potential approval. If approved, it could become the first targeted treatment for Sjögren’s disease, as per Novartis.

Sjögren’s disease is a systemic, chronic autoimmune disorder that causes inflammation and tissue damage, impacting the entire body. It primarily affects exocrine glands, leading to excessive dryness, with over 90% of patients experiencing dry eyes and dry mouth.

The Breakthrough Therapy designation is intended to expedite the review of medicines that treat a serious or life-threatening condition. 

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