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Roche's Genentech Announces Phase III ALLEGORY Study Results Demonstrating Statistically Significant And Clinically Meaningful Improvement With Gazyva In Systemic Lupus Erythematosus

Author: Benzinga Newsdesk | November 03, 2025 02:21am

Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva, an anti-CD20 monoclonal antibody designed for enhanced B cell depletion
Gazyva has the potential to be a transformative new standard of care for up to 3.4 million people affected by systemic lupus erythematosus (SLE) worldwide
If approved, Gazyva would be the first anti-CD20 therapy for SLE to directly target B cells, a key driver of inflammation and disease activity
These positive results follow the recent U.S. FDA approval and positive EU CHMP opinion for Gazyva in lupus nephritis, alongside positive Phase III data from the INShore study in idiopathic nephrotic syndrome

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