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Investing.com -- Novartis (SIX:NOVN) stock rose 2.2% on Monday after the pharmaceutical giant announced positive top-line results from two Phase III clinical trials evaluating ianalumab in adults with active Sjögren’s disease.
The company reported that both NEPTUNUS-1 and NEPTUNUS-2 trials met their primary endpoint, demonstrating statistically significant improvements in disease activity.
These are the first global Phase III trials to show such improvements for Sjögren’s disease, positioning ianalumab to potentially become the first targeted treatment approved for this condition.
Ianalumab, which has a dual mechanism of action through B-cell depletion and BAFF-R inhibition, was well tolerated and demonstrated a favorable safety profile in the trials. The drug was previously granted Fast Track Designation by the U.S. Food and Drug Administration.
Shreeram Aradhye, President of Development and Chief Medical (TASE:BLWV) Officer at Novartis, highlighted the significance of the results, noting that Sjögren’s disease is a "serious, progressive, systemic autoimmune disease" with limited treatment options and an established unmet need.
The company plans to present detailed data at an upcoming medical meeting and submit ianalumab to health authorities globally.
"Overall, we believe that the detailed data is needed to fully assess the strength of the efficacy benefit seen and, hence, we expect the shares to outperform by just 2-3% today," according to JP Morgan analysts.
Sjögren’s disease is a chronic autoimmune condition that primarily affects moisture-producing glands, causing symptoms like dry eyes and mouth, but can also affect other parts of the body.