The FDA is scheduled to announce its decision on Roche Holding AG’s (RHHBY.OB) supplemental Biologics License Application for Gazyva for the treatment of lupus nephritis in October.Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.In clinical trials, Gazyva plus standard therapy showed improved complete renal response compared with standard therapy alone in patients with lupus nephritis.If approved in the expanded indication, Gazyva will have to compete with GlaxoSmithKline’s Benlysta and Aurinia Pharma’s Lupkynis.The drug, which is already approved for various types of lymphoma in 100 countries, including the U.S, generated total sales of CHF910 million in 2024, up 16% over the prior year. RHHBY.OB closed Friday’s (September 26, 2025) trading at $39.59, down 0.93%.