Systemic Lupus Erythematosus
RHHBYRoche HoldingCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Gazyva®/Gazyvaro® (obinutuzumab) (CD20 Antibody) in Systemic Lupus Erythematosus. The expected timing is based on the latest available company guidance and may change.
02/07/26:- Phase 3 ALLEGORY trial of Gazyva/Gazyvaro in systemic lupus erythematosus met primary and key secondary endpoints. 04/21/26:- FDA accepted sBLA for SLE; approval decision expected in December 2026. 05/06/26:- NEJM published ALLEGORY Ph3 data showing Gazyva/Gazyvaro significantly reduced disease activity in systemic lupus erythematosus.
Verification
Confirm timing and program details against the company announcement or filing.