Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), announced on Wednesday that the US Food and Drug Administration (FDA) has granted priority review to its supplemental Biologics License Application for Gazyva (obinutuzumab) to treat adults with primary membranous nephropathy (pMN).

This follows the drug's earlier Breakthrough Therapy Designation in pMN. The FDA is expected to make its approval decision by November 2026.

The application is supported by Phase III MAJESTY data showing Gazyva achieved significantly higher complete remission rates than tacrolimus, an immunosuppressive therapy, in adults with pMN. At 104 weeks, 36.9% of patients treated with Gazyva achieved complete remission compared with 5.7% for tacrolimus, while the study also met key secondary endpoints for overall remission and complete remission at week 76. Genentech said the safety profile was consistent with previous studies and no new safety signals were identified.

If approved, Gazyva would become the first FDA-approved treatment for pMN, a chronic autoimmune kidney disease that currently has no FDA- or EMA-approved therapies. The MAJESTY results were presented at the 2026 European Renal Association Congress, published in the New England Journal of Medicine, and are being submitted to additional global regulatory authorities, including the European Medicines Agency.