Novartis (NVS) received FDA Breakthrough Therapy designation for ianalumab in treating Sjogren’s disease. The monoclonal antibody targets B-cells and achieved significant improvements in disease activity in phase III studies.
Ianalumab, expected to launch in 2026, is the first targeted therapy for Sjogren’s if approved. Novartis shares have surged 48% in the past year. (50 words)

Novartis’ ianalumab, developed with MorphoSys AG, also received Fast Track designation in 2016. Sjogren’s disease is a debilitating autoimmune disorder with no approved therapies.
Ianalumab is being studied in other autoimmune diseases and has shown promise in systemic lupus erythematosus and immune thrombocytopenia. (50 words)

Positive results from the VAYHIT2 study showed ianalumab plus eltrombopag extended ITP disease control by 45%. Novartis plans to submit data to health authorities in 2027.
NVS carries a Zacks Rank #3 (Hold). Better-ranked biotech stocks include MNKD, KROS, and FOLD, each with a Zacks Rank #1 (Strong Buy). (50 words)

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Investors can access Zacks’ latest stock recommendations for free. For more information on Novartis and other stocks, visit Zacks Investment Research. (50 words)

Read more at Nasdaq: Novartis’ Ianalumab Wins Breakthrough Therapy Tag for Sjogren’s Disease