Novartis announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to ianalumab for Sjögren's disease, the second most prevalent rheumatic autoimmune disease.
Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and inhibits their activation and survival via BAFF-R blockade.
The company noted that it plans to submit ianalumab for regulatory approval globally starting in early 2026. If approved, ianalumab would become the first targeted treatment for patients with Sjögren's disease.
Sjögren's disease is a serious, progressive, autoimmune condition that affects multiple organs causing a wide spectrum of symptoms such as dryness, fatigue, pain, and an increased risk of lymphoma, which can carry a significant burden and impact on quality of life.
NVS closed Friday's regular trading session at $144.34, rising $1.19 or 0.83% as of 4:00 PM EST. In after-hours trading, the stock inched up to $144.35, a modest gain of $0.01 or 0.01%.
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Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.