Genentech Announces Positive Phase III Results for Gazyva in Primary Membranous Nephropathy

Gazyva could become the first approved treatment for this autoimmune disease, marking a significant milestone.

Published on Feb. 16, 2026

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Genentech announced that the Phase III MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, showing statistically significant and clinically meaningful results with Gazyva. The study demonstrated that significantly more people achieved complete remission at two years with Gazyva versus tacrolimus. Gazyva has the potential to address this condition by targeting an underlying cause, which may help maintain kidney function for longer and prevent the onset of life-threatening complications.

Why it matters

Primary membranous nephropathy is a chronic autoimmune condition that can lead to irreversible kidney damage and failure, requiring invasive interventions like dialysis or transplant. Up to 30% of people with this disease progress to kidney failure over 10 years despite current treatment approaches. Achieving complete remission is critical to help delay or prevent these serious and potentially fatal complications.

The details

The MAJESTY study enrolled 142 people who were randomized 1:1 to receive Gazyva or tacrolimus. The primary endpoint was the percentage of people who achieved complete remission at two years. Analysis of key secondary endpoints also showed statistically significant and clinically meaningful benefits with Gazyva versus tacrolimus in overall remission and complete remission at earlier timepoints.

  • The MAJESTY study is the first global Phase III study in primary membranous nephropathy.
  • The study met its primary endpoint at two years (104 weeks).

The players

Genentech

A leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. Genentech is a member of the Roche Group.

Gazyva

A glycoengineered, anti-CD20 monoclonal antibody designed to achieve deep tissue B cell depletion. Gazyva is approved in the U.S. and EU for the treatment of adults with active lupus nephritis and is being investigated in other immune-mediated diseases.

Primary Membranous Nephropathy

A chronic autoimmune condition that causes potentially irreversible kidney damage and reduced kidney function, affecting over 96,000 people in the U.S.

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What they’re saying

“These results demonstrate that Gazyva may help more people with primary membranous nephropathy achieve complete remission, maintain kidney function for longer and delay or potentially prevent the onset of life-threatening complications.”

— Levi Garraway, Chief Medical Officer and Head of Global Product Development, Genentech

What’s next

Data from the MAJESTY study will be presented at an upcoming medical meeting and shared with health authorities including the U.S. Food and Drug Administration and the European Medicines Agency.

The takeaway

If approved, Gazyva would be the first therapy specifically indicated for people with primary membranous nephropathy, providing a new treatment option for this chronic autoimmune condition that can lead to irreversible kidney damage and failure.