Announcement • 18h

Roche Announces FDA Grants Priority Review to Roche’s Gazyva/Gazyvaro for Adults with Primary Membranous Nephropathy

Roche announced that the US Food and Drug Administration (FDA) has granted Priority Review to the company’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of primary membranous nephropathy (pMN). The priority review is based on the positive phase III MAJESTY results, which show superiority of Gazyva/Gazyvaro over an immunosuppressive therapy, tacrolimus, in adults with pMN. The FDA has already granted Breakthrough Therapy Designation (BTD) to Gazyva/Gazyvaro in pMN and is expected to make a decision on approval by November 2026. This is the second indication in recent months for which the US FDA has granted priority review to Gazyva/Gazyvaro, following idiopathic nephrotic syndrome in May 2026. If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome. The phase III MAJESTY study met its primary endpoint, with 36.9% of adults achieving complete remission (CR) at two years (104 weeks) with Gazyva/Gazyvaro versus 5.7% with tacrolimus (adjusted difference 31.1%; 95% confidence interval [CI] 18.2 to 44.0; p<0.001). Key secondary endpoints showed that Gazyva/Gazyvaro was superior to tacrolimus in achieving overall remission (complete or partial remission) at week 104 and complete remission at week 76. Safety was in line with the well-characterised profile of Gazyva/Gazyvaro and no new safety signals were identified. The data were featured at the 63rd European Renal Association (ERA) Congress in June 2026 as a late-breaking oral presentation and published in the New England Journal of Medicine (NEJM). In April 2026, the FDA granted Breakthrough Therapy Designation for Gazyva/Gazyvaro in pMN. Data from MAJESTY are also being submitted to other global health authorities, including the European Medicines Agency. MAJESTY is the fourth positive phase III study of Gazyva/Gazyvaro in immune-mediated diseases, following REGENCY in lupus nephritis, ALLEGORY in systemic lupus erythematosus (SLE) and INShore in idiopathic nephrotic syndrome – where it also received priority review and Breakthrough Therapy Designation by the FDA. Gazyva/Gazyvaro is approved in the US and EU for the treatment of adults with active lupus nephritis who are receiving standard therapy based on data from the REGENCY and NOBILITY studies, and is being investigated in the phase II POSTERITY study for children and adolescents with lupus nephritis. Gazyva/Gazyvaro (obinutuzumab) is a humanised monoclonal antibody designed with a Type II anti-CD20 region, for direct B cell death, and a glycoengineered Fc region, for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC). CD20 is a protein found on certain types of B cells. Gazyva/Gazyvaro is approved for adults with lupus nephritis in the US and the EU. Gazyva/Gazyvaro is also approved in 100 countries for various types of haematological cancers. MAJESTY [NCT04629248] is a phase III, randomised, open-label, multicentre study designed to evaluate the efficacy and safety of Gazyva/Gazyvaro (obinutuzumab) in adults with primary membranous nephropathy. The study enrolled 142 adults who were randomised 1:1 to receive Gazyva/Gazyvaro or tacrolimus. The primary endpoint is the percentage of adults who achieve complete remission at two years (week 104). Primary membranous nephropathy is 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, idiopathic nephrotic syndrome, blood clots and cardiovascular diseases. Achieving complete remission is important to help maintain kidney function and delay or prevent the onset of serious and potentially fatal complications. Primary membranous nephropathy has an estimated incidence of 1.2 per 100,000 people in the United States per year.

Announcement • Jul 14

Roche Introduces Cobas Hepatitis D Virus Test for Use on Cobas 5800/6800/8800 Systems

Roche introduced the cobas HDV test for use on the cobas 5800/6800/8800 systems, a diagnostic tool for the detection and quantification of Hepatitis D Virus (HDV) RNA, in countries accepting the CE mark. The new test enables clinicians to reliably diagnose HDV and monitor patients’ treatment response. Hepatitis D affects nearly 12 million of people globally and is considered the most aggressive form of viral hepatitis, often leading to liver failure and cancer faster than other types. The cobas HDV test is the first high-throughput, fully automated HDV assay on the market, addressing the urgent need for a consistent, widely accessible solution and expanding access to critical testing just as new treatments for the disease become available. Available on the industry-leading cobas 5800/6800/8800 systems, Roche aims to help healthcare providers in identifying patients and monitoring their care more effectively alongside newly available treatments. Hepatitis D, which globally affects an estimated 12 million people, is a unique ‘satellite virus’ that can only infect people who already have the Hepatitis B virus (HBV). Because of this relationship, it can occur as a co-infection, that is, being infected with both viruses at once, or a super-infection, which is being infected with HDV after already having chronic Hepatitis B. Co-infection could explain about 1 in 5 cases of liver disease, and super-infection being particularly dangerous with over 90% of cases becoming chronic and accelerating to liver damage. Despite the severity of the disease, testing has often been limited to manual methods or lab-developed tests that can vary in consistency. The cobas HDV test is the first high-throughput, fully automated HDV assay on the market and addresses the urgent need for a consistent, widely accessible solution. This is particularly important now that specific treatments for HDV are becoming available in many markets, requiring precise monitoring to ensure they are working and to advance patient care. The assay runs on the fully automated cobas 5800/6800/8800 systems. These fully automated platforms are already used in laboratories worldwide, allowing for seamless integration into existing workflows. By automating the testing process, laboratories can deliver accurate results faster and more efficiently, helping clinicians make timely decisions for their patients. Hepatitis D leads to faster progression toward liver failure, cirrhosis, and liver cancer compared to other forms of hepatitis. Symptoms can be severe and include jaundice (yellowing of the skin and eyes), extreme fatigue, abdominal pain, and nausea. The virus is transmitted through contact with infected blood or bodily fluids. Because it requires Hepatitis B to replicate, vaccination against Hepatitis B is the most effective way to prevent Hepatitis D infection.

Roche Holding AG Stock Price

ROP Share Price Performance

ROP Community Narratives

Late Stage Pipeline And Diagnostics Expansion Will Reshape Long Term Prospects

Roche is a cash-generating, defensive large-cap pharma, with upside driven by pipeline execution.

Large Late Stage Pipeline And US Investment Will Support Steady Healthcare Demand

Roche is a cash-generating, defensive large-cap pharma, with upside driven by pipeline execution.

Late Stage Pipeline And Diagnostics Expansion Will Reshape Long Term Prospects

Large Late Stage Pipeline And US Investment Will Support Steady Healthcare Demand

Late Stage Pipeline And Diagnostics Expansion Will Transform Long Term Healthcare Leadership

Trending Discussion

Recently Updated Narratives

Roche is a cash-generating, defensive large-cap pharma, with upside driven by pipeline execution.

ROP: Pipeline Partnerships And Oncology Data Will Shape Balanced Outlook

ROP: External Oncology Collaborations Will Likely Cap Near Term Upside

Snowflake Analysis

Roche Holding AG Key Details

About ROP

Recent ROP News & Updates

Roche Announces FDA Grants Priority Review to Roche’s Gazyva/Gazyvaro for Adults with Primary Membranous Nephropathy

Roche Unveils First Fully Automated HDV Test for Severe Hepatitis Detection and Monitoring

Roche Introduces Cobas Hepatitis D Virus Test for Use on Cobas 5800/6800/8800 Systems

Recent updates

Roche Holding AG Competitors

Novartis

Lonza Group

Galderma Group