Novartis now sees the potential for the drug to become the first and only targeted treatment approved for patients with the disease.
Novartis (NVS) on Monday announced positive results from its late-stage trials evaluating its investigational drug Ianalumab in adults with active Sjögren’s disease.
Ianalumab is a novel fully human monoclonal antibody being investigated for its potential to treat various B-cell-driven autoimmune diseases. The drug’s mechanism of action targets B cells in two ways: combining B cell depletion and interruption of BAFF-R-mediated signals of B cell function and survival.
Guggenheim said the positive updates give evidence that BAFF-signaling disruption and B cell depletion are “a valid approach” for hard-to-treat autoimmune diseases, which has a positive read-through for Zura Bio (ZURA). Shares of Zura, which Guggenheim deems “significantly undervalued,” traded 3% higher at the time of writing.
Novartis said that its two late-stage trials for Sjögren’s disease met the primary endpoint of demonstrating statistically significant improvements in disease activity. Novartis now sees the potential for the drug to become the first and only targeted treatment approved for patients with the disease.
On Stocktwits, retail sentiment around Novartis jumped from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘normal’ levels.
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.
“These Phase III studies mark a significant milestone. We look forward to engaging with health authorities to discuss these findings in the near future,” said Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis.
Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren’s disease, the company said, while adding that it plans to submit the drug to health authorities globally.
NYSE-listed shares of the company traded 1% higher at the time of writing.
Ianalumab originated from Novartis’ early collaboration with MorphoSys AG, a company which it later acquired in 2024. In clinical trials, Ianalumab showed promising efficacy and a favorable safety profile in Sjögren’s disease, systemic lupus erythematosus, and immune thrombocytopenia.
While NVS shares are up by 21% this year, ZURA is down 42%.
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