European Commission approves Roche’s Gazyva/Gazyvaro for adults with active lupus nephritis

Rhea-AI Summary

Roche (RHHBY) announced that the European Commission approved Gazyva/Gazyvaro (obinutuzumab) on 9 December 2025 for adults with active Class III or IV, with or without Class V, lupus nephritis, in combination with mycophenolate mofetil (MMF).

The approval was based on phase II NOBILITY and phase III REGENCY results: 46.4% of patients on Gazyva plus standard therapy achieved complete renal response versus 33.1% on standard therapy alone. Data also showed reduced corticosteroid use and improved proteinuric response. The EC decision follows a U.S. FDA approval in October 2025. Roche said the treatment could benefit up to an estimated 135,000 people with lupus nephritis in the EU.

Positive

• REGENCY result: 46.4% vs 33.1% complete renal response
• European Commission approval for adult active Class III/IV ±V lupus nephritis (9 Dec 2025)
• Shown to reduce corticosteroid use in trial data
• Potential to affect up to 135,000 people with lupus nephritis in the EU

Negative

• Approval limited to adults with Class III/IV ±V lupus nephritis; pediatric use remains investigational
• Indication requires combination with MMF, restricting use to patients on that standard therapy

News Market Reaction – RHHBY

-0.41%

1 alert

-0.41% News Effect

On the day this news was published, RHHBY declined 0.41%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Complete renal response (combo): 46.4% Complete renal response (control): 33.1% Estimated EU patients: 135,000 people +5 more

8 metrics

Complete renal response (combo) 46.4% Phase III REGENCY, Gazyva/Gazyvaro + standard therapy

Complete renal response (control) 33.1% Phase III REGENCY, standard therapy alone

Estimated EU patients 135,000 people Adults affected by lupus nephritis in the European Union

Progression to ESKD One third Proportion progressing to end-stage kidney disease within 10 years

Follow-up duration 10 years Timeline over which up to one third progress to ESKD

Phase II study NOBILITY Phase II trial supporting lupus nephritis approval

Phase III study REGENCY Phase III trial showing superiority over standard therapy

FDA approval date October 2025 U.S. FDA approval for adults with active lupus nephritis

Market Reality Check

Price: $59.35 Vol: Volume 4,598,153 is 1.76x...

high vol

$59.35 Last Close

Volume Volume 4,598,153 is 1.76x the 20-day average of 2,619,116. high

Technical Trading above 200-day MA, with price 50.02 vs 200-day MA at 41.66, near 52-week high 50.67.

Peers on Argus

Peers in Drug Manufacturers - General were mixed, with moves from -1.9% (DSNKY) ...

Peers in Drug Manufacturers - General were mixed, with moves from -1.9% (DSNKY) to small gains like 0.13% (ALPMY), while RHHBY showed a stronger 3.55% pre-news rise, pointing to stock-specific strength.

Historical Context

5 past events · Latest: Dec 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	Diagnostic launch	Positive	-0.4%	CE Mark and launch of cobas BV/CV PCR assay for vaginitis testing.
Dec 09	Regulatory approval	Positive	-0.4%	EU approval of Gazyva/Gazyvaro for adults with active lupus nephritis.
Dec 08	Clinical data update	Positive	-0.4%	Lunsumio data showing strong responses and survival in lymphoma cohorts.
Dec 08	Clinical data update	Positive	-0.4%	Genentech Lunsumio data in earlier lymphoma lines with high CR and ORR.
Dec 08	Clinical trial follow-up	Positive	+0.8%	Three-year STARGLO data showing Columvi combo survival and PFS benefit.

Pattern Detected

Recent positive clinical and approval news often coincided with flat to slightly negative next-day moves, indicating a tendency for mild divergence between upbeat headlines and immediate price reaction.

Recent Company History

Over 8–9 December 2025, Roche released several positive updates, including EU approval for Gazyva/Gazyvaro in lupus nephritis and multiple lymphoma data sets for Lunsumio and Columvi, plus a new CE-marked vaginitis PCR assay. Despite the fundamentally positive tone of these items, most saw modestly negative -0.41% next-day moves, with only the Columvi phase III follow-up associated with a positive 0.78% reaction. The current EU approval fits this stream of late-2025 pipeline and diagnostic milestones.

Market Pulse Summary

This announcement detailed European Commission approval of Gazyva/Gazyvaro plus mycophenolate mofeti...

Analysis

This announcement detailed European Commission approval of Gazyva/Gazyvaro plus mycophenolate mofetil for adults with active Class III or IV lupus nephritis, based on phase II NOBILITY and phase III REGENCY results. The regimen achieved a complete renal response of 46.4% versus 33.1% on standard therapy alone and may benefit up to 135,000 people in the EU. Historical news flow shows a stream of positive clinical and regulatory milestones, so watching real-world adoption and safety signals will be important.

Key Terms

anti-cd20 antibody, complete renal response, end-stage kidney disease, mycophenolate mofetil, +4 more

8 terms

anti-cd20 antibody medical

"Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a benefit"

An anti-CD20 antibody is a manufactured protein that specifically attaches to CD20, a marker on certain immune cells called B cells, tagging them for removal or changing how they act. For investors, these antibodies are important because they can form the basis of drugs that treat cancers and autoimmune diseases; progress in trials, regulatory approval, manufacturing scale-up, or competition can significantly affect a drugmaker’s future sales and valuation, much like a single new product can reshape a company’s prospects.

complete renal response medical

"demonstrate a benefit in a complete renal response in lupus nephritis"

Complete renal response is a clinical outcome that indicates a patient’s kidneys have returned to near-normal function, usually shown by a big drop in protein leaking into the urine and stable waste levels in the blood. For investors, it matters because this endpoint is a clear signal that a drug or treatment is working in kidney disease trials, which can drive regulatory approval, market adoption, and commercial value much like a successful safety test validates a new car model.

end-stage kidney disease medical

"helping to delay or prevent end-stage kidney disease"

A permanent, irreversible loss of normal kidney function so the body can no longer reliably filter waste and balance fluids without medical intervention, typically managed with regular dialysis or a kidney transplant. Investors watch it because it creates a steady, long-term demand for drugs, devices, treatment services and insurance spending — similar to a fleet of vehicles that require constant repairs or replacement, producing predictable recurring revenue opportunities.

mycophenolate mofetil medical

"in combination with mycophenolate mofetil (MMF) for the treatment"

An immunosuppressant drug used to prevent the body from attacking transplanted organs and to treat certain autoimmune conditions by dialing down the immune system’s activity. For investors, its importance lies in market size, patent status, regulatory approvals, competition from generics or alternatives, and safety profiles—factors that influence sales, revenue predictability, and legal or regulatory risk. Think of it as a medical “dimmer switch” that lowers immune response to avoid damage.

glucocorticoids medical

"plus standard therapy (MMF and glucocorticoids) achieved a complete"

Glucocorticoids are a class of steroid hormones, produced naturally by the body and also made as medicines, that reduce inflammation and suppress immune responses. They matter to investors because they are widely used across many diseases, drive significant drug sales, and carry safety, regulatory and patent implications—think of them as a thermostat that can turn down harmful inflammation but may also lower overall immune defenses, creating trade-offs for treatment and product risk.

proteinuric response medical

"reduction of corticosteroid use and an improvement in proteinuric response"

A proteinuric response describes how the amount of protein in a patient’s urine changes after a treatment or over time, signaling whether the kidneys are leaking more or less protein. Investors watch this because decreasing urine protein often indicates a drug is helping protect or repair kidney function, while increasing protein can signal worsening disease or side effects — like seeing a leaky pipe get better or worse after repairs.

complement levels medical

"improvements in complement levels and reductions in anti-dsDNA"

Complement levels are blood measurements of a set of proteins that help the immune system identify and clear infections or damaged cells; think of them as parts of the body’s internal alarm and cleanup crew. Investors watch these levels because changes can indicate whether an immune-related disease is active or whether a drug is affecting the immune system, which can influence demand for therapies, trial outcomes, regulatory reviews, and diagnostic markets.

anti-dsdna medical

"improvements in complement levels and reductions in anti-dsDNA were observed"

Anti-dsDNA are antibodies the immune system makes that mistakenly target the body's own double-stranded DNA; they are a blood marker commonly used to diagnose and monitor autoimmune conditions like lupus. For investors, levels of these antibodies matter because they drive demand for diagnostic tests, influence clinical trial design and approval of targeted therapies, and can affect market value of companies developing treatments or lab tests—think of them as a measurable signal investors watch to judge disease activity and commercial opportunity.

AI-generated analysis. Not financial advice.

• Approval based on phase II NOBILITY and phase III REGENCY studies showing superiority of Gazyva/Gazyvaro over standard therapy alone^1,2
• Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a benefit in a complete renal response in lupus nephritis in a randomised phase III study²
• Gazyva/Gazyvaro could become a new standard of care for up to an estimated 135,000 people affected by lupus nephritis in the European Union, potentially helping to delay or prevent end-stage kidney disease^3,4 

Basel, 9 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Gazyva®/Gazyvaro® (obinutuzumab) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis. These disease classifications describe the extent and nature of damage to the kidneys and renal function, a key characteristic of lupus nephritis.

“This approval marks a major advance in the treatment of lupus nephritis for people across Europe who wrestle with this disease,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “By controlling disease activity, Gazyva/Gazyvaro could help delay or prevent progression to end-stage kidney disease and the need for dialysis or transplant, underscoring its potential to become a new standard of care in Europe.”

The approval is based on positive results from the phase II NOBILITY and phase III REGENCY studies. Key results from REGENCY, published in the New England Journal of Medicine, demonstrated that 46.4% of people on Gazyva/Gazyvaro plus standard therapy (MMF and glucocorticoids) achieved a complete renal response compared to 33.1% on standard therapy alone. Data showed a statistically significant and clinically meaningful reduction of corticosteroid use and an improvement in proteinuric response, all signalling improved disease control. Additionally, clinically meaningful improvements in complement levels and reductions in anti-dsDNA were observed, both markers of disease activity and inflammation. The safety profile of Gazyva/Gazyvaro was consistent with the well-characterised profile observed in its haematology-oncology indications.²

“The symptoms of lupus nephritis and their unpredictable nature can impact quality of life, emotional wellbeing and limit future family and career prospects,” said Jeanette Andersen, Chair of Lupus Europe. “This approval for Gazyva/Gazyvaro offers a much needed treatment that may help ease the burden of living with this complex disease and reflects the vital role of patient community experts in trial development.”

Lupus nephritis is a potentially life-threatening disease that predominantly affects women of colour and childbearing age, with up to an estimated 135,000 people currently living with the condition across the European Union.^3-5 With current treatments, up to one third of people will progress to end-stage kidney disease (ESKD) within 10 years, where the only options are dialysis or transplant.⁶ New treatments that can effectively control the disease may help delay or prevent the onset of ESKD.^6,7

This approval follows the Gazyva/Gazyvaro approval by the US Food and Drug Administration for the treatment of adults with active lupus nephritis who are receiving standard therapy in October 2025. Additionally, recent positive phase III read-outs in childhood idiopathic nephrotic syndrome and adult systemic lupus erythematous support the potential of Gazyva/Gazyvaro to help address disease activity across a spectrum of autoimmune or immune-related diseases.

Gazyva/Gazyvaro continues to be investigated in children and adolescents with lupus nephritis and adults with membranous nephropathy, as part of our ambition to be leaders in immune-mediated rheumatology and nephrology diseases.^8,9

About Gazyva/Gazyvaro
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).¹⁰ CD20 is a protein found on certain types of B cells. 

Gazyva/Gazyvaro is approved for adults with lupus nephritis in the United States and European Union and in over 100 countries for various types of haematological cancers.

About the REGENCY study
REGENCY [NCT04221477] is a phase III, randomised, double-blind, placebo-controlled, multicentre study investigating the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomised 1:1 to receive either Gazyva/Gazyvaro plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust phase II data and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis. 

About Lupus nephritis
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.¹¹ Lupus nephritis is characterised by an irreversible loss of nephrons, the filtering structures of the kidneys. Periods of intense disease activity, known as flares, can speed up the loss of nephrons and, if left unchecked, may lead to a progressive loss of kidney function. Even with the latest treatments, up to a third of people will progress to end-stage kidney disease, where dialysis or transplant are the only options and life expectancy and quality of life are substantially reduced.⁶

Lupus nephritis affects more than 1.7 million people worldwide – predominantly women, mostly of colour and usually of childbearing age.^5,12,13 Currently, there is no cure.¹¹

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law. 

References
[1] Furie RA, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-07.
[2] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83.
[3] Cornet A, et al. Experiences and unmet needs of persons living with systemic lupus erythematosus in Europe: Lupus Europe's 2024 Swiss knife survey. Autoimmun Rev. 2025 Jul 31;24(8):103838.
[4] Bechler KK, et al. Predicting patients who are likely to develop Lupus Nephritis of those newly diagnosed with Systemic Lupus Erythematosus. AMIA Annu Symp Proc. 2023 Apr 29:2022:221-30.
[5] Anders HJ et al. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7.
[6] Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol. 2023 Apr;19(4):227-38.
[7] American College of Rheumatology (ACR). New ACR guideline summary provides guidance to screen, treat, and manage lupus nephritis. [Internet; cited 2025 December 8]. Available from: https://rheumatology.org/press-releases/new-acr-guideline-summary-provides-guidance-to-screen-treat-and-manage-lupus-nephritis.
[8] Clinicaltrials.gov. A study to evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab in adolescents with active class III or IV lupus nephritis and the safety and PK of obinutuzumab in pediatric participants (POSTERITY). [Internet; cited 2025 December 8]. Available from: https://clinicaltrials.gov/study/NCT05039619.
[9] Clinicaltrials.gov. A study evaluating the efficacy and safety of obinutuzumab in participants with primary membranous nephropathy (MAJESTY). [Internet; cited 2025 December 8]. Available from: https://clinicaltrials.gov/study/NCT04629248.
[10] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.
[11] Hocaoglu M et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades using the Lupus Midwest Network. Arthritis & Rheumatol 2023 Apr;75(4):567-5.
[12] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023 Mar;82:351-56.
[13] Bastian HM, et al. Systemic lupus erythematosus in three ethnic groups. XII. Risk factors for lupus nephritis after diagnosis. Lupus. 2002;11(3):152-60. 

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

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Roche Investor Relations

Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
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Investor Relations North America

Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com

Attachment

• Media Investor Release EU Approval Gazyva Lupus Nephritis English

FAQ

What did Roche announce about Gazyva/Gazyvaro (RHHBY) on December 9, 2025?

The company said the European Commission approved Gazyva/Gazyvaro with MMF for adults with active Class III or IV, with or without Class V, lupus nephritis.

What were the key REGENCY trial results for Gazyva/Gazyvaro (RHHBY)?

REGENCY showed 46.4% complete renal response with Gazyva plus standard therapy versus 33.1% with standard therapy alone.

How might the EC approval of Gazyva/Gazyvaro (RHHBY) affect steroid use in lupus nephritis patients?

Clinical data reported a statistically significant and clinically meaningful reduction in corticosteroid use versus standard therapy alone.

Is Gazyva/Gazyvaro (RHHBY) approved in the U.S. for lupus nephritis?

Yes. The announcement notes a U.S. FDA approval in October 2025 for adults with active lupus nephritis receiving standard therapy.

How many people could be eligible for Gazyva/Gazyvaro (RHHBY) in the EU?

Roche estimates up to 135,000 people living with lupus nephritis across the European Union could be affected by the approval.

Does the EC approval of Gazyva/Gazyvaro (RHHBY) cover children with lupus nephritis?

No. The approval covers adults; the company is continuing trials in children and adolescents.