Primary Membranous Nephropathy
RHHBYRoche HoldingCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Gazyva®/Gazyvaro® (obinutuzumab) (CD20 Antibody) in Primary Membranous Nephropathy. The expected timing is based on the latest available company guidance and may change.
02/15/26:- MAJESTY Phase 3 in primary membranous nephropathy met primary endpoint; data to be presented and shared with regulators. 05/06/26:- MAJESTY Ph3 in primary membranous nephropathy met primary endpoint of complete remission at two years. 07/15/26:- FDA priority review sBLA for pMN; approval decision expected November 2026. MAJESTY CR 36.9% vs 5.7%. 07/23/26:- MAJESTY Priority Review was reiterated; FDA decision is expected in November 2026.
Verification
Confirm timing and program details against the company announcement or filing.