Welcome to our dedicated page for Novartis SEC filings (Ticker: NVS), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
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Novartis announced positive top-line results from two global Phase III trials (NEPTUNUS-1 and NEPTUNUS-2) of ianalumab in adults with active Sjögren's disease. Both trials met the primary endpoint, demonstrating statistically significant improvements in systemic disease activity measured by reduction in ESSDAI versus placebo.
NEPTUNUS-1 enrolled 275 patients and NEPTUNUS-2 enrolled 504, evaluating ianalumab 300 mg subcutaneous monthly or every three months versus placebo for up to 52 weeks. Novartis reported ianalumab was well tolerated with a favorable safety profile, described the medicine as having dual B cell-directed activity, and said it plans to present the data and submit to health authorities globally. The program has FDA Fast Track designation, and the release notes there is no guarantee of approval or commercial success.
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