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

• If approved, Ianalumab could become the first targeted treatment for Sjögren’s disease. 
• The Breakthrough Therapy designation was granted to Novartis on the basis of clinical evidence supporting the drug’s potential.
• In Novartis’ late-stage trials evaluating the efficacy and safety of Ianalumab in patients with Sjögren’s disease, the drug delivered a clinically meaningful benefit.

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.

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.

According to Novartis, 50% of people with Sjögren’s are undiagnosed, though it is the second-most prevalent rheumatic autoimmune 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.

The Designation

The Breakthrough Therapy designation, granted to Novartis on the basis of clinical evidence supporting the drug’s potential, is intended to expedite the review of medicines that treat a serious or life-threatening condition. Ianalumab was previously awarded the FDA’s Fast Track designation in 2016.

In Novartis’ late-stage trials that evaluated the efficacy and safety of Ianalumab in patients with Sjögren’s disease, the drug delivered a clinically meaningful benefit, showing improvement in disease activity and reductions in patient burden. Further, the drug demonstrated a favorable safety profile with an overall incidence of adverse events comparable to placebo.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around NVS stock stayed within the ‘neutral’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.

NVS stock has gained nearly 48% over the past 12 months. 

Read More: NVO Shares Rise On Strong Kickstart For Wegovy Pill In US: Retail Eyes Up To $110 As ‘Fair Value’

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