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

Gazyva could become the first approved treatment for this autoimmune disease

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 ® (obinutuzumab). The study demonstrated that significantly more people achieved complete remission at two years with Gazyva versus tacrolimus. If approved, Gazyva would be the first therapy specifically indicated for people with primary membranous nephropathy, where there are limited treatment options.

Why it matters

Primary membranous nephropathy is a chronic autoimmune condition that can lead to kidney failure, requiring invasive interventions like dialysis or transplant. Up to 30% of people with the condition will develop kidney failure over 10 years, which has a significant impact on patients and health systems. Gazyva has the potential to help maintain kidney function for longer and prevent the onset of life-threatening 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 met its primary endpoint at two years (week 104).
  • Data 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 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 European Union for the treatment of adults with active lupus nephritis and is being investigated in a range of immune-mediated diseases.

Primary Membranous Nephropathy

A chronic autoimmune condition where the body's immune system attacks the filtering units of the kidney, the glomeruli, causing protein to leak into the urine and potentially a gradual decline in kidney function. Over time, the damage to the kidneys can become irreversible, increasing the risk of life-threatening complications, such as kidney failure.

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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 (Business Wire)

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, addressing a significant unmet need for patients at risk of developing kidney failure and other life-threatening complications from this chronic autoimmune condition.