Viromed Medical AG: Globally unique preclinical data base – Saarland validation as key step toward first physical lung application

Viromed Medical AG

/ Key word(s): Miscellaneous

Viromed Medical AG: Globally unique preclinical data base – Saarland validation as key step toward first physical lung application

16.02.2026 / 10:14 CET/CEST

The issuer is solely responsible for the content of this announcement.


Viromed Medical AG: Globally unique preclinical data base – Saarland validation as key step toward first physical lung application

Rellingen, 16 February 2026 – As part of a scientific press conference on 12 February 2026, Prof. Dr. Hortense Slevogt, study director at Hannover Medical School and Head of the Respiratory Department at the Helmholtz Centre for Infection Research, presented the current status of the preclinical development of cold plasma therapy (Cold Atmospheric Plasma, CAP) for the treatment of severe infectious lung diseases. The study uses the cold plasma technology of Viromed Medical AG (“Viromed”).

Prof. Dr. Slevogt explained that a full disclosure of all data details was deliberately omitted, as publication of the results in a recognized international peer-reviewed journal is imminent. The delay in publication is due to the decision to submit a particularly comprehensive and scientifically high-quality fast-track paper that meets the highest international standards.

According to the study management, the basic research conducted over the past 2.5 years on human lung epithelial models has consistently produced positive results. A significant, pathogen-independent reduction of pathogenic germs was demonstrated, while maintaining a clearly defined therapeutic safety window. Histological analyses and examinations showed no safety-relevant tissue damage within this application window.

To Viromed’s knowledge, there are currently no comparable preclinical study programs worldwide that have investigated a physical cold plasma application directly in pulmonary tissue to this extent. The available data therefore represent, in the company’s assessment, an internationally unique scientific foundation for a non-pharmacological treatment of severe lung infections.

Based on these data, regulatory consultation meetings have already taken place in which the requirements for a potential application in critically ill intensive care patients were clearly defined – particularly with regard to a structured benefit-risk assessment.

The validation study now initiated in the vital lung organ model at Saarland University represents the decisive translational step. With a planned duration of 10 to 12 weeks, the preclinically defined dosing parameters are to be finally confirmed under physiologically realistic conditions. This phase is considered key to transferring the scientifically defined benefit-risk profile into clinical application. The focus is on patients with fulminant lung infections caused by pathogenic germs, in particular ventilator-associated pneumonias (VAP), which continue to show high mortality despite guideline-compliant therapy and in which conventional antibiotic strategies are increasingly losing effectiveness.

In addition, Prof. Dr. Slevogt emphasized the considerable preventive potential of the technology. In the future, CAP could help to prevent severe disease courses at an early stage. The study management also sees significant application potential in the context of influenza-associated bacterial/viral secondary infections.

Against the backdrop of globally increasing antibiotic resistance, high mortality in severe pneumonias, and limited therapeutic alternatives, CAP, in Viromed’s assessment, addresses a significant international unmet need in the intensive care setting.

Uwe Perbandt, Member of the Management Board of Viromed Medical AG: “With a globally unique preclinical data base and a clearly defined therapeutic window, we are at a decisive point of translation. The regulatory discussions have defined the framework conditions for an application in critically ill patients. If the validation at Saarland University confirms these parameters, we see a realistic perspective to initiate the next steps toward clinical application in early summer. We are convinced that a physical, non-pharmacological therapy in the field of severe lung infections will attract international attention. In our view, the coming weeks represent the decisive transition from preclinical validation to clinical reality.”

 

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

Contact Viromed

E-Mail: kontakt@viromed-medical.de

Press contact

E-mail: viromed@kirchhoff.de


16.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

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Language: English
Company: Viromed Medical AG
Hauptstraße 105
25462 Rellingen
Germany
E-mail: kontakt@viromed-medical.de
Internet: https://www.viromed-medical-ag.de/
ISIN: DE000A40ZVN7
WKN: A40ZVN
Listed: Regulated Unofficial Market in Dusseldorf, Frankfurt, Hamburg, Tradegate BSX
EQS News ID: 2276884

 
End of News EQS News Service

2276884  16.02.2026 CET/CEST

Sartorius Stedim Biotech releases Universal Registration Document 2025

Sartorius Stedim Biotech SA

/ Key word(s): Annual Results

Sartorius Stedim Biotech releases Universal Registration Document 2025

16-Feb-2026 / 09:13 CET/CEST


Aubagne, France | February 16, 2026

Sartorius Stedim Biotech releases Universal Registration Document 2025

Sartorius Stedim Biotech, a leading partner of the biopharma industry, today released its Universal Registration Document 2025 including the Annual Financial Report. The document is available at the following link: https://www.sartorius.com/urd2025  

Financial calendar 
March 24, 2026 | Annual Shareholders’ Meeting   
April 23, 2026 | Publication of the first quarter results for January to March 2026 
July 23, 2026 | Publication of half-year results for January to June 2026 
October 22, 2026 | Publication of nine-month results January to September 2026 

A profile of Sartorius Stedim Biotech 
Sartorius Stedim Biotech is a leading international partner of the biopharmaceutical industry. As a provider of innovative solutions, the company based in Aubagne, France, helps its customers to manufacture biotech medications, such as cell and gene therapies, safely, rapidly, and sustainably. The shares of Sartorius Stedim Biotech S.A. are quoted on the Euronext Paris. The company has a strong global reach with manufacturing and R&D sites as well as sales entities in Europe, North America, and Asia. Sartorius Stedim Biotech regularly expands its portfolio through acquisitions of complementary technologies. In 2025, the company generated sales revenue of around 3 billion euros, according to preliminary figures. Currently, more than 10,200 employees are working for customers around the globe.   
 
Visit our newsroom and follow us on LinkedIn. 

Contact
Verena Sattel 
External Communications 
+49 551 308 9261 
verena.sattel@sartorius.com 


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File: Sartorius Stedim Biotech releases Universal Registration Document 2025 | Media Release


Dissemination of a Financial Wire News, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.



2275078  16-Feb-2026 CET/CEST

GN Store Nord A/S – Notice to convene the Annual General Meeting 2026

GN Store Nord A/S – Notice to convene the Annual General Meeting 2026




GN Store Nord A/S – Notice to convene the Annual General Meeting 2026

GN Store Nord’s Annual General Meeting will be held on Wednesday, March 11, 2026, at 10:00 a.m. CET at the company’s address: Lautrupbjerg 7, 2750 Ballerup, Denmark.

Please find attached the notice to convene the Annual General Meeting, including the agenda and complete proposals.

For further information, please contact:

Investor Relations
Rune Sandager +45 45 75 92 57

Media Relations
Steen Frentz Laursen +45 20 65 34 20

About GN
GN facilitates communication between people through intelligent hearing, audio, video, and gaming technology. Inspired by people and driven by our passion for innovation, we leverage technologies to deliver unique user experiences that bring people closer through the power of sound and vision.

GN was founded more than 150 years ago with a vision to connect the world. Today, we proudly honor that legacy with our world-leading expertise in the human ear, audio, video and speech, wireless technologies, software, miniaturization, and collaboration with leading technology partners. GN’s solutions are marketed by the brands ReSound, SteelSeries, Jabra, Beltone, Interton, BlueParrott, Danavox and FalCom in 100 countries. Founded in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO).

Visit our homepage GN.com – and connect with us on LinkedIn, Facebook and X.

Attachment

Harness Therapeutics Nominates HRN001, a First-in-Class Drug Candidate for Huntington’s Disease and Establishes Clinical Advisory Board

Harness Therapeutics Nominates HRN001, a First-in-Class Drug Candidate for Huntington’s Disease and Establishes Clinical Advisory Board




Harness Therapeutics Nominates HRN001, a First-in-Class Drug Candidate for Huntington’s Disease and Establishes Clinical Advisory Board

       

HRN001 is a potent and specific antisense oligonucleotide designed to drive controlled upregulation of FAN1, a genetically validated target in Huntington’s disease

Clinical Advisory Board formed to support progression of HRN001 into first-in-human studies in 2027

Dr Andy Billinton, CSO will present preclinical data at the upcoming CHDI Foundation Huntington’s Disease Therapeutics Conference

Cambridge, UK, 16 February 2026: Harness Therapeutics (‘Harness’), a biotechnology company unlocking previously undruggable targets to transform the treatment of neurodegenerative diseases, today announces the nomination of HRN001 as its lead drug candidate for Huntington’s disease and the formation of a clinical advisory board to support the programme’s advancement towards clinical evaluation.

Huntington’s disease (HD) is a devastating, inherited neurodegenerative disorder that leads to progressive cognitive, psychiatric and motor decline, with death often occurring within 15 years of symptom onset. Despite significant advances in understanding HD disease biology, there are currently no approved disease-modifying treatments available.

HD is caused by the expansion of CAG repeats in the huntingtin (HTT) gene. Ongoing somatic expansion of these repeats is now recognised as a key driver of disease onset and progression. FAN1 nuclease has emerged as one of the most compelling targets to suppress somatic expansion, demonstrating the strongest genetic association to disease onset in genome-wide association studies.

Our first-in-class candidate HRN001 is a potent and specific antisense oligonucleotide targeting FAN1, designed to drive controlled upregulation of this key DNA repair nuclease. It leverages Harness’ proprietary MISBA® (microRNA site blocking ASO) platform, which enables precise upregulation of target protein levels without risk of over-expression.

HRN001 has demonstrated robust upregulation of FAN1 and slowing of somatic expansion in models of HD, as well as favourable PK and tolerability characteristics. Preclinical development will continue throughout 2026 to support clinical entry in 2027. Harness is exploring the potential of the MISBA® platform in other triplet repeat disorders and across a broader pipeline of neurodegenerative disorders.

To support the progression of HRN001 towards the clinic, Harness has established a clinical advisory board (CAB) comprising leading experts in the HD field, including:

Dr. Irina Antonijevic (Chair) – Chief Medical Officer, Trace Neuroscience
Dr. Anne Rosser – Professor of Clinical Neuroscience, Cardiff University
Dr. Jeffrey Long – Professor of Psychiatry and Biostatistics, University of Iowa Health Care
Dr. Ralf Reilmann – Founding Director and Chief Executive Officer, George-Huntington-Institute
Dr. Roger Barker – Professor of Clinical Neuroscience, University of Cambridge
Dr. Sarah Tabrizi – Professor of Clinical Neurology, University College London
Dr. William Gray – Professor of Functional Neurosurgery, Cardiff University

The CAB will provide strategic guidance on clinical development, trial design, and translational strategy as the programme advances towards the clinic.

Dr Andy Billinton, Chief Scientific Officer of Harness Therapeutics, will present the company’s work in HD at the upcoming annual CHDI Huntington’s Disease Therapeutics Conference in Palm Springs, California, 23rd-26th February, providing further insights into the scientific rationale and development progress for HRN001.

Dr Jan Thirkettle, CEO of Harness Therapeutics, commented: “The nomination of HRN001 represents a pivotal milestone for Harness and underscores our commitment to the Huntington’s disease community. By precisely upregulating FAN1, a target with compelling genetic validation in delaying disease onset, HRN001 represents a differentiated, first-in-class therapeutic approach for addressing somatic expansion, a fundamental driver of disease progression. The formation of a Clinical Advisory Board brings deep clinical and translational expertise to the programme. The CAB will work closely with Harness as we advance HRN001 towards the clinic and seek to deliver a truly disease-modifying therapy for patients and families living with Huntington’s disease.”

Dr Irina Antonijevic, Chair of Harness Therapeutics’ Clinical Advisory Board, added: “FAN1 is one of the most compelling and consistently validated genetic modifiers of Huntington’s disease identified to date, with a clear mechanistic link to somatic expansion and disease progression. Harness’ approach with HRN001 offers a novel and highly targeted way to therapeutically modulate this pathway. We look forward to advising the Company, as it advances HRN001 toward the clinic, translating this promising science into a clinical programme that could meaningfully alter the course of this devasting disease.”

CHDI presentation details
Title: Upregulation of FAN1 with ASOs as a potential therapeutic strategy for triplet repeat disorders
Session: Somatic Instability/Mismatch Repair
Date: Tuesday 24 February
Presenter: Dr Andy Billinton, CSO of Harness Therapeutics

CAB biographies

Dr. Irina Antonijevic (Chair) is an experienced clinician and drug development leader, widely recognized for her leadership in advancing innovative therapies from early development through clinical stages, particularly in areas with high unmet medical needs such as neurodegenerative and psychiatric disorders. She currently serves as Chief Medical Officer at Trace Neuroscience, bringing over three decades of experience in clinical psychiatry, neurology, academic research, and therapeutic drug development. Dr. Antonijevic is a board-certified physician trained in both psychiatry and neurology, with deep expertise in translational medicine and clinical development strategies.

Dr. Anne Rosser is Professor of Clinical Neuroscience at Cardiff University and an Honorary Consultant Neurologist at the University Hospital of Wales, leading the South Wales clinical service for Huntington’s disease. She co-leads the Cardiff University Brain Repair Group, a multidisciplinary research team focused on developing cell-based and regenerative therapies for neurodegenerative diseases. Dr. Rosser previously served as Chair of the European Huntington’s Disease Network (EHDN) and is currently Chair of the Scientific Committee of the Lister Institute of Preventive Medicine.

Dr. Jeffrey D. Long is Professor of Psychiatry and Biostatistics at the University of Iowa Health Care / Carver College of Medicine where he applies statistical modeling to neurodegenerative diseases, with a special emphasis on Huntington’s disease. He develops and refines disease progression indexes, critical for understanding natural disease trajectories and planning clinical trials. Dr Long also serves as Lead Biostatistician for NIH-funded longitudinal studies, such as REDICT-HD, and plays a key role as Head Biostatistician in the Data Coordinating Center of the NeuroNEXT clinical trials network.

Dr. Ralf Reilmann is Founding Director and Chief Executive Officer of the George-Huntington-Institute (GHI) in Münster, Germany, a private research institute devoted to clinical care and research in Huntington’s disease. Under his leadership, the Institute participates in key Huntington’s observational studies including ENROLL-HD and clinical trials exploring disease-modifying therapies and gene therapy approaches. Dr. Reilmann is a board-certified neurologist, widely recognized for his commitment to improving trial outcomes, patient care, and global collaboration in Huntington’s research.

Dr. Roger Barker Professor of Clinical Neuroscience at the University of Cambridge and Honorary Consultant Neurologist at Addenbrooke’s Hospital, Cambridge. He serves as Lead Academic Scientist for the Alzheimer’s Research UK Drug Discovery Institute in Cambridge and Lead Consultant for the East of England Huntington’s Disease Service. His research focuses on clinical characterization of neurodegenerative disorders and the development of new therapeutic approaches, especially cell- and gene-based treatments. Dr. Barker has led and coordinated major research programmes, including European projects and stem cell trials for Parkinson’s disease as well as a range of trials in Huntington’s disease.

Dr. Sarah Tabrizi is Professor of Clinical Neurology at University College London, internationally recognised for her research in neurodegenerative diseases, particularly Huntington’s disease. She holds several prestigious roles across UCL’s neuroscience community and the UK’s top clinical research institutions recognised with many major awards. Her work has transformed the Huntington’s field, establishing frameworks for disease staging, biomarker development, and therapeutic trials that serve as models for other neurodegenerative conditions. Dr. Tabrizi’s bench-to-bedside approach integrates deep biological insight with clinical trials to bring hope to patients with previously untreatable conditions.

Dr. William Gray is Professor of Functional Neurosurgery at Cardiff University and Honorary Consultant Neurosurgeon at the University Hospital of Wales. He brings dual expertise in clinical neurosurgery and neuroscience research, especially focused on disorders like epilepsy, Parkinson’s disease, Huntington’s disease, and frontotemporal dementia. He serves as Director of the Advanced NeuroTherapies Centre (ANTC), developing and delivering emerging therapies directly to the brain, is the Academic Lead in Neurosurgery in Wales, and Head of the Brain Repair and Intracranial Neurotherapeutics (BRAIN) Unit. Dr. Gray is the UK Chief Investigator for the uniQure AMT-130 gene therapy trial in Huntington’s disease and Principal Investigator for gene therapy trials in frontotemporal dementia and Parkinson’s disease. He also co-leads the European Huntington’s Disease Network ATMP Working Group and chairs its Surgical Delivery Task Force.

-ENDS-

About Harness Therapeutics 
Harness Therapeutics is a biotechnology company focused on unlocking previously undruggable targets to transform the treatment of neurodegenerative diseases. Its MISBA® platform technology enables precise upregulation of target protein levels by modulating mechanisms controlling protein synthesis. Harness’ recently announced MISBA® Duo technology enables the design of single constructs which simultaneously upregulate one target whilst downregulating a second. Using its deep understanding of post-transcriptional regulation and sophisticated neuron-based models, Harness’ approach allows drugging of potentially disease-modifying targets, which would not be addressable using gene therapy or other modalities.

Its lead candidate in Huntington’s Disease, HRN001, targets FAN1 nuclease, a key protective protein, shown to slow disease progression. Its pipeline also includes programmes addressing compelling first in class targets for ALS, Alzheimer’s Disease, and Parkinson’s Disease.

Harness has assembled a world-class team, supported by leading experts in neurodegeneration and RNA biology, and is based in Cambridge, UK. Its leading life science investors include the foundational investors Takeda Ventures and SV Health Investors’ Dementia Discovery Fund, alongside Epidarex Capital and Ono Ventures Investment.

For more information, please visit https://www.harnesstx.com/ and follow us on LinkedIn.

For further information, please contact:        

ICR Healthcare
Amber Fennell, Stephanie Cuthbert,
Tel: +44 20 3709 5700
Email: harnesstx@icrinc.com

Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470

Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470




Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470

Press Release
Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470
  • U.S. NDA submission on track for summer 2026
  • Nicox to receive milestone payment from Kowa upon submission of the NDA
  • NDA submission based on Phase 3 clinical data showing NCX 470 lowered intraocular pressure by up to 10mmHg in patients with open-angle glaucoma or ocular hypertension

February 16, 2026 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that it has received positive written feedback from its NCX 470 pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration (FDA). The minutes confirm that the current data package and the proposed content and format of the proposed NDA application is generally acceptable for submission. The FDA requested complementary pharmacokinetic data, which will be generated in a small number of patients as part of an ongoing study in Japan, and will not impact any timelines. The NDA remains on track for submission in summer 2026. NCX 470 (bimatoprost grenod) is a novel nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

“The productive and collaborative pre-NDA meeting with the FDA was conducted with our partner Kowa. The outcome supports the finalisation of our registration dossier with its comprehensive data package, including positive results from two Phase 3 studies, and facilitates proceeding with submitting the NCX 470 New Drug Application to the U.S. Food and Drug Administration. Nicox will now transfer ownership of the application to Kowa to make the submission as planned in the summer of 2026,” said Doug Hubatsch, EVP and Chief Scientific Officer of Nicox.

NCX 470 is licensed globally to Kowa, except in the Chinese market, South Korea and Southeast Asia, where it is licensed to Ocumension Therapeutics. Nicox may receive regulatory and sales milestones and will be paid royalties on worldwide sales. All regulatory and commercialisation costs are borne by Kowa and Ocumension.

Key Future Milestones

  • NCX 470 NDA submission in the United States: expected in summer 2026
  • NCX 470 NDA submission in China: expected shortly after submission in the U.S.
  • NCX 470 Phase 3 clinical program in Japan: initiated in summer 2025.  
About Nicox
Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health.  Nicox’s lead late-stage development program is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa in the rest of the world.  Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos.  Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories.  Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.

Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX).

For more information www.nicox.com

Analyst coverage

H.C. Wainwright & Co Yi Chen New York, U.S.

 
The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.
Contacts  
Nicox
Gavin Spencer
Chief Executive Officer
T +33 (0)4 97 24 53 00
communications@nicox.com

 
Disclaimer
The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.

Risk factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2024” and in section 4 of the “Rapport semestriel 2025” which are available on Nicox’s website (www.nicox.com).

Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.

Nicox S.A.
Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, France
T +33 (0)4 97 24 53 00

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Roche announces positive phase III results for Gazyva/Gazyvaro in primary membranous nephropathy, marking a significant milestone in this autoimmune disease

Roche announces positive phase III results for Gazyva/Gazyvaro in primary membranous nephropathy, marking a significant milestone in this autoimmune disease




Roche announces positive phase III results for Gazyva/Gazyvaro in primary membranous nephropathy, marking a significant milestone in this autoimmune disease

  • MAJESTY, the first global phase III study in primary membranous nephropathy, met its primary endpoint of complete remission at two years
  • Up to 30% of people with membranous nephropathy progress to kidney failure over 10 years despite current treatment approaches; achieving complete remission can help delay or prevent this1,2
  • Gazyva/Gazyvaro could become the first approved treatment for primary membranous nephropathy, having already achieved positive results in lupus nephritis, systemic lupus erythematosus and idiopathic nephrotic syndrome
  • Gazyva/Gazyvaro is a glycoengineered, anti-CD20 monoclonal antibody designed to achieve deep tissue B cell depletion

Basel, 16 February 2026 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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®/Gazyvaro® (obinutuzumab). Results show that significantly more people achieved complete remission at two years (104 weeks) with Gazyva/Gazyvaro versus tacrolimus. Safety was in line with the well-characterised profile of Gazyva/Gazyvaro and no new safety signals were identified.

“These results demonstrate that Gazyva/Gazyvaro 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,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “If approved, Gazyva/Gazyvaro would be the first therapy specifically indicated for people with primary membranous nephropathy, where there are limited treatment options.”

Analysis of key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva/Gazyvaro versus tacrolimus in overall remission (complete or partial remission) at week 104 and complete remission at week 76.

Data will be presented at an upcoming medical meeting and shared with health authorities including the US Food and Drug Administration and the European Medicines Agency.

Primary membranous nephropathy is a chronic autoimmune condition that causes potentially irreversible kidney damage and reduced kidney function, and it is estimated that it affects  nearly 88,000 people in the EU and over 96,000 in the US. Up to 30% of people with primary membranous nephropathy will develop kidney failure over 10 years, which requires invasive intervention like dialysis or transplant and has a significant impact on patients and their families, as well as carrying substantial cost to health systems.1,2 Gazyva/Gazyvaro has the potential to address this by targeting an underlying cause of the condition, which may help maintain kidney function for longer and prevent the onset of life-threatening complications.

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 and INShore in idiopathic nephrotic syndrome. This growing body of evidence supports Gazyva/Gazyvaro’s potential in addressing disease activity across a spectrum of immune-mediated diseases.

Gazyva/Gazyvaro is approved in the US and EU for the treatment of adults with active lupus nephritis based on data from the REGENCY and NOBILITY studies and is being investigated in a global phase II study of children and adolescents with lupus nephritis.3,4 Beyond Gazyva/Gazyvaro, we have a broad pipeline as part of our ambition to be leaders in immunology, in particular in immune-mediated and kidney-related diseases.

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). CD20 is a protein found on certain types of B cells.

Gazyva/Gazyvaro is approved for adults with lupus nephritis in the US and EU. Gazyva/Gazyvaro is also approved in 100 countries for various types of haematological cancers.

About the MAJESTY study
MAJESTY [NCT04629248] is a phase III, randomised, open-label,  multicentre study designed to evaluate the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) in people with primary membranous nephropathy. The study enrolled 142 people who were randomised 1:1 to receive Gazyva/Gazyvaro or tacrolimus. The primary endpoint is the percentage of people who achieve complete remission at two years (week 104).

About primary membranous nephropathy
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 disease. Achieving complete remission is critical to help maintain kidney function and delay or prevent the onset of serious and potentially fatal complications.

About Roche in kidney and kidney-related diseases
For more than 20 years, we have combined innovation, scientific expertise and commitment to patients to address unmet needs in kidney diseases. Today, our industry-leading programme includes Gazyva®/Gazyvaro® (obinutuzumab), approved in the US and EU for adults with active lupus nephritis, and more than 10 phase II-III clinical studies in immune-mediated kidney and kidney-related diseases with some of the highest unmet needs.

Our aim is to continue delivering meaningful value for those affected, healthcare systems and society, and help address this growing public health burden.

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] Keri KC, et al.  Primary membranous nephropathy: comprehensive review and historical perspective. Postgrad Med L. 2019 Jan;95(1119). doi: 10.1136/postgradmedj-2018-135729.
[2] Kanigicherla DAK, et al. Long-term outcomes of persistent disease and relapse in primary membranous nephropathy. Nephrol Dial Transplant. 2016 Dec:31(12):2108-2114. doi: 10.1093/ndt/gfv435. Epub 2016 Jan 13.
[3] 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.
[4] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83.

Roche Global Media Relations
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Phone: +41 79 407 72 58
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Roche Investor Relations

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e-mail: bruno.eschli@roche.com
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Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com

 

Dr Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
 

Investor Relations North America

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

Attachment

Press Release: Beyfortus study published in The Lancet Infectious Diseases shows benefit for infants beyond first RSV season

Press Release: Beyfortus study published in The Lancet Infectious Diseases shows benefit for infants beyond first RSV season




Press Release: Beyfortus study published in The Lancet Infectious Diseases shows benefit for infants beyond first RSV season

Beyfortus study published in The Lancet Infectious Diseases shows benefit for infants beyond first RSV season

  • First study showing that infants immunized against RSV in their first season had fewer RSV hospitalizations in their second season
  • The study also showed a reduction of 85.9% in RSV-related lower respiratory tract infection hospitalizations in the first season

Data published in The Lancet Infectious Diseases and to be presented at RSVVW ’26 conference in Rome

Paris, February 16, 2026. A universal respiratory syncytial virus (RSV) immunization program using Beyfortus (nirsevimab) was associated with a statistically significant reduction in RSV-related hospitalizations in the second RSV season among infants immunized during their first season, according to a new study published in The Lancet Infectious Diseases. The NIRSE-GAL study, conducted in Galicia, Spain, is the first prospective real-world population study to evaluate the impact of a universal Beyfortus immunization program during two consecutive RSV seasons. The study findings, comparing the number of hospitalizations in immunized infants during their second RSV season versus the number of expected hospitalization cases based on data from recent seasons, are being presented at RSVVW ’26 (Respiratory Syncytial Virus Vaccines for the Word) conference in Rome, Italy.

The coverage rate was 94.4% among the cohort (11,796 infants out of 12,492 eligible) and the study showed a substantial reduction of 85.9% (95% confidence interval [CI] 80.2–90.0) in RSV-related lower respiratory tract infection (LRTI) hospitalizations during the first season. The study also showed 55.3% (95% CI 22.5-74.3) fewer hospitalizations in the second RSV season among infants who received a dose of Beyfortus during infancy. By preventing severe RSV infections during the first months of life, a critical period of lung development, it is thought the infants may be less prone to subsequent admissions from either RSV or other infections.

“This universal RSV immunization program with Beyfortus showed decreased RSV-related hospitalizations and outpatient illness burden during the first season, with persistent impact seen on RSV hospitalizations through the second season,” said Federico Martinón-Torres, Head of Pediatrics at Santiago University Hospital in Spain, and principal investigator of the NIRSE-GAL study. “These results offer compelling population-based data to inform infant immunization strategies and economic evaluation models.”

“This study builds upon our wealth of evidence supporting the public health value of a Beyfortus immunization program,” said Thomas Triomphe, Executive Vice President, Vaccines, Sanofi. “It’s exciting to see the significant impact of this infant immunization program during the first RSV season and truly remarkable to consider a benefit across two seasons.”

Further findings
The study also showed reductions in primary care consultations during the first RSV season, including:

  • 30.8% (17.5-41.9) reduction in first consultations for acute bronchitis or bronchiolitis;
  • 33.4% (21.6-43.4) reduction in consultations for lower respiratory tract infections and;
  • 27.7% (14.9-38.5) reduction in consultations for wheezing or asthma.

Furthermore, rehospitalizations in infants previously hospitalized due to RSV decreased considerably during the second RSV season, with a 78.2% (25.6–93.6) reduction in RSV-related rehospitalizations and a 62.4% (30.9–79.6) reduction in LRTI rehospitalizations. These data support the hypothesis that early protection against RSV-related damage to the lungs may have lasting beneficial effects on respiratory health.

About RSV
RSV is a highly contagious virus that can lead to serious respiratory illness for infants. It is a leading cause of hospitalization in all infants, with most hospitalizations for RSV occurring in otherwise healthy infants born at term. Older infants born before the RSV season are also at risk of RSV disease and make up around half of infant RSV hospitalizations. Two out of three infants are infected with RSV during their first year of life and almost all children are infected by their second birthday. Globally, in 2019, there were approximately 33 million cases of RSV-associated acute lower respiratory infections leading to more than three million hospitalizations and an estimated 26,300 in-hospital RSV-attributable deaths of children younger than five years. RSV-related direct medical costs, globally — including hospital, outpatient, and follow-up care — were estimated at c.€5 billion in 2017.

About Beyfortus
Beyfortus (nirsevimab) is the first RSV immunization designed to help protect all infants through their first RSV season, including for those born healthy at term or preterm, and those with health conditions that make them vulnerable to RSV disease. Beyfortus is also approved for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

With an extended half-life of 71 days, Beyfortus is a long-acting monoclonal antibody for the prevention of RSV lower respiratory tract disease in infants.  Administration is timed to coincide with the RSV season and is provided directly to newborns and infants as a single dose. Beyfortus offers rapid protection without requiring activation of the immune system.

Along with efficacy and safety demonstrated in clinical studies, the effectiveness of Beyfortus has been evaluated in more than 50 real-world studies, including more than 400,000 infants who were immunized. Since the launch, over 11 million infants have been immunized with Beyfortus across more than 45 countries.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | + 33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | + 1 617 356 4751 | victor.rouault@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com
Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com
Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com

Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com

Sanofi forward-looking statement
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group. 

 

Attachment

New ECCO data show subcutaneous (SC) infliximab (Remsima™  SC) effectively recaptures and maintains disease control after drug holiday

New ECCO data show subcutaneous (SC) infliximab (Remsima™  SC) effectively recaptures and maintains disease control after drug holiday




New ECCO data show subcutaneous (SC) infliximab (Remsima™  SC) effectively recaptures and maintains disease control after drug holiday

  • A new post-hoc analysis from the LIBERTY studies, presented at ECCO 2026, demonstrated that initiating subcutaneous (SC) infliximab (Remsima™ SC) after a treatment interruption following intravenous (IV) infliximab induction helps patients with Crohn’s disease (CD) and ulcerative colitis (UC) recapture and maintain disease control1
  • The results demonstrated that SC infliximab provides an effective and safe option to regain clinical control after a planned or unplanned treatment interruption
  • More than a total of 30 accepted abstracts including one oral and one digital oral presentation and eight posters, reinforce Celltrion’s commitment to inflammatory bowel disease (IBD) research aimed at enhancing patient outcomes

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion, Inc. today announced new data from a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), showing that subcutaneous (SC) infliximab restored and maintained response in most Crohn’s disease (CD) and ulcerative colitis (UC) patients with sustained efficacy, safety, and persistence through to Week 102.1 The data will be presented as a poster presentation at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO), to be held from February 18-21 in Stockholm, Sweden.


“As immunogenicity is the most significant concern when restarting treatment with infliximab after an interruption, these results suggest that treatment persistence was maintained even in patients with immunogenicity,” said Dr. Marla Dubinsky, Professor of Pediatrics and Director of the IBD Center at the Icahn School of Medicine at Mount Sinai. “It’s reassuring to see that not only can we effectively recapture disease control with a convenient subcutaneous option, but that this response was seen early and was shown to be maintained through Week 102 in a post-hoc analysis from the pivotal LIBERTY studies. This is a significant finding for patients, as it offers a potentially reliable strategy for providers and transformative opportunity for patients to manage their IBD journey even when treatment is interrupted.”

“In clinical practice, patients may experience treatment interruption for clinical and non-clinical reasons, and initiation of treatment demands careful consideration of the risks,” said Professor Stefan Schreiber, University Hospital Schleswig-Holstein, Department of Medicine I, Kiel, Germany. “This data provides evidence that subcutaneous infliximab can effectively and safely recapture disease control, offering a viable treatment option for both clinicians and patients.”

The analysis evaluated the efficacy and safety of starting SC infliximab 240mg in patients, randomised to the placebo maintenance arm in the Phase 3 LIBERTY studies, who had previously completed intravenous (IV) infliximab induction and subsequently experienced a drug holiday of 16 weeks or more before starting SC infliximab due to disease progression.

Among 51 CD and 77 UC patients who initiated treatment with SC infliximab, clinical response was observed early by 8±2 weeks and was maintained through the study. At the end of the treatment, 61.1% in CD and 65.2% in UC patients achieved faecal calprotectin remission, and 64.0% in CD and 68.8% in UC patients achieved endoscopic response/ improvement. Persistence in treatment end was 72.3% of CD patients and 61.9% of UC patients. Serum infliximab levels increased after initiating SC infliximab and remained stable through Week 102, with no new safety concerns observed.

The results demonstrated that initiation of treatment with SC infliximab 240 mg was effective to recapture and maintain disease control for Crohn’s disease (CD) and ulcerative colitis (UC) patients, suggesting SC infliximab provides an effective and safe option to regain clinical control after a planned or unplanned treatment interruption.

Additionally, Celltrion will host a satellite symposium titled, “Enhancing Patient Management with Subcutaneous Infliximab: Practical Insights & Discussion.” on Friday, February 20 from 12:45 to 13:25, in Room A12 at Stockholmsmässan. Chaired by Professor Jean-Frédéric Colombel, the symposium will feature presentations from Professor Anthony Buisson and Professor Axel Dignass.

“The comprehensive data from the studies reinforces the growing body of evidence supporting subcutaneous infliximab as a critical treatment option for the gastroenterology community,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “The data presented at ECCO 2026 further demonstrate our leadership and long-standing commitment to raising standards of care in gastroenterology and to improving the lives of people with Inflammatory Bowel Disease.”

Notes to Editors:

About the subcutaneous (SC) formulation of CT-P13

CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of CT-P13 SC has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.2,3 In July 2024, CT-P13 SC received final approval from the European Commission for an additional dosing regimen and dose escalation, which allows 3-intraveneous (IV) induction dosing regimen and dose escalation of subcutaneous maintenance dose from CT-P13 SC 120 mg Q2W to 240 mg Q2W for patients with loss of response.4 Long term data from two-year extension of the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) have demonstrated sustained efficacy and safety of CT-P13 SC, with clinical remission, response, and corticosteroid-free remission generally maintained through Week 102.5

About Celltrion

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media – LinkedIn, Instagram, X, and Facebook.

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as “prepares”, “hopes to”, “upcoming”, “plans to”, “aims to”, “to be launched”, “is preparing”, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, “anticipates”, the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries’ management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.

Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.

References

____________________

1 Colombel JF et al., Recapturing disease control with subcutaneous infliximab after a drug holiday following intravenous infliximab induction: A post hoc analysis of LIBERTY-CD and -UC studies. Poster Presentation (P0832) at ECCO 2026.

2 Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353.

3 Westhovens R et al., Rheumatology. 2021;60(5):2277-2287.

4 European Medicines Agency. Remsima – Summary of Product Characteristics (SmPC). [Accessed January 2026]

5 Colombel JF et al., Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Crohn’s Disease and Ulcerative Colitis: 2-Year Results from Open Label Extensions of Two Randomized Controlled Trials (LIBERTY). Journal of Crohn’s and Colitis. 2025;19(6):jjaf060.

 

Contacts

For further information please contact:
Donna Gandhi

dgandhi@hanovercomms.com
+44 (0) 7827 053 502

Genentech Announces Positive Phase III Results for Gazyva in Primary Membranous Nephropathy, Marking a Significant Milestone in This Autoimmune Disease

Genentech Announces Positive Phase III Results for Gazyva in Primary Membranous Nephropathy, Marking a Significant Milestone in This Autoimmune Disease




Genentech Announces Positive Phase III Results for Gazyva in Primary Membranous Nephropathy, Marking a Significant Milestone in This Autoimmune Disease

– MAJESTY, the first global Phase III study in primary membranous nephropathy, met its primary endpoint of complete remission at two years –

– Up to 30% of people with membranous nephropathy progress to kidney failure over 10 years despite current treatment approaches; achieving complete remission can help delay or prevent this –

– Gazyva could become the first approved treatment for primary membranous nephropathy, having already achieved positive results in lupus nephritis, systemic lupus erythematosus and idiopathic nephrotic syndrome –

– Gazyva is a glycoengineered, anti-CD20 monoclonal antibody designed to achieve deep tissue B cell depletion –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today 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). Results show that significantly more people achieved complete remission at two years (104 weeks) with Gazyva versus tacrolimus. Safety was in line with the well-characterized profile of Gazyva and no new safety signals were identified.


“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,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “If approved, Gazyva would be the first therapy specifically indicated for people with primary membranous nephropathy, where there are limited treatment options.”

Analysis of key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva versus tacrolimus in overall remission (complete or partial remission) at week 104 and complete remission at week 76.

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.

Primary membranous nephropathy is a chronic autoimmune condition that causes potentially irreversible kidney damage and reduced kidney function, and it is estimated that it affects over 96,000 people in the U.S. Up to 30% of people with primary membranous nephropathy will develop kidney failure over 10 years, which requires invasive intervention like dialysis or transplant and has a significant impact on patients and their families, as well as carrying substantial cost to health systems. Gazyva has the potential to address this by targeting an underlying cause of the condition, which may help maintain kidney function for longer and prevent the onset of life-threatening complications.

MAJESTY is the fourth positive Phase III study of Gazyva in immune-mediated diseases, following REGENCY in lupus nephritis, ALLEGORY in systemic lupus erythematosus and INShore in idiopathic nephrotic syndrome. This growing body of evidence supports Gazyva’s potential in addressing disease activity across a spectrum of immune-mediated diseases.

Gazyva is approved in the U.S. and European Union for the treatment of adults with active lupus nephritis based on data from the REGENCY and NOBILITY studies and is being investigated in a global Phase II study of children and adolescents with lupus nephritis. Beyond Gazyva, we have a broad pipeline as part of our ambition to be leaders in immunology, in particular in immune-mediated and kidney-related diseases.

About Gazyva

Gazyva® (obinutuzumab) is a humanized 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 is approved for adults with lupus nephritis in the US and EU. Gazyva is also approved in 100 countries for various types of hematological cancers.

About the MAJESTY Study

MAJESTY [NCT04629248] is a Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of Gazyva® (obinutuzumab) in people with primary membranous nephropathy. The study enrolled 142 people who were randomized 1:1 to receive Gazyva or tacrolimus. The primary endpoint is the percentage of people who achieve complete remission at two years (week 104).

About Primary Membranous Nephropathy

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 disease. Achieving complete remission is critical to help maintain kidney function and delay or prevent the onset of serious and potentially fatal complications.

GAZYVA Indications

GAZYVA® (obinutuzumab) is a prescription medicine used:

  • With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment
  • With the chemotherapy drug, bendamustine, followed by GAZYVA alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment
  • With chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III, or IV FL in adults who have not had previous FL treatment
  • For the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy

Important Safety Information

The most important safety information patients should know about GAZYVA

Patients must tell their doctor right away about any side effect they experience. GAZYVA can cause side effects that can become serious or life-threatening, including:

  • Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If the patient has a history of hepatitis B infection, GAZYVA could cause it to return. Patients should not receive GAZYVA if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen them for hepatitis B before, and monitor the patient for hepatitis during and after, their treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes.
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. The patient’s weakened immune system could put them at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems.

Who should not receive GAZYVA:

Patients should NOT receive GAZYVA if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to GAZYVA. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past.

Additional possible serious side effects of GAZYVA:

Patients must tell their doctor right away about any side effect they experience. GAZYVA can cause side effects that may become severe or life-threatening, including:

  • Infusion-Related Reactions: These side effects may occur during or within 24 hours of any GAZYVA infusion. Some infusion-related reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion-related reactions. If the patient has a reaction, the infusion is either slowed or stopped until their symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion-related reaction is life-threatening, the infusion of GAZYVA will be permanently stopped. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each GAZYVA treatment. Symptoms of infusion-related reactions may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort.
  • Hypersensitivity Reactions Including Serum Sickness: Some patients receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, the patient’s doctor will stop the infusion and permanently discontinue GAZYVA
  • Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. GAZYVA works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart and may lead to kidney failure requiring the need for dialysis treatment. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness. TLS is not identified as a risk in LN.
  • Serious, Including Fatal, Infections: While the patient is taking GAZYVA, they may develop infections. Some of these infections may be fatal and severe, so the patient should be sure to talk to their doctor if they think they have an infection. Patients administered GAZYVA in combination with chemotherapy, followed by GAZYVA alone are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients taking GAZYVA plus standard therapy may be at higher risk for fatal or severe infections compared to patients taking standard therapy plus placebo. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking GAZYVA plus CHOP or CVP. If the patient develops a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection.
  • Low White Blood Cell Count: When the patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking GAZYVA, their doctor will do blood work to check their white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If the patient’s white blood cell count is low, their doctor may prescribe medication to help prevent infections.
  • Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets the patient has in their blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While the patient is taking GAZYVA, their doctor will do blood work to check their platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If the patient’s platelet count gets too low, their treatment may be delayed or reduced.
  • Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by the patient’s doctor as it can lead to uncontrollable bleeding.

The most common side effects of GAZYVA in CLL were infusion-related reactions and low white blood cell counts.

The most common side effects seen with GAZYVA in a study that included relapsed or refractory NHL, including FL patients, were infusion-related reactions, fatigue, low white blood cell counts, cough, upper respiratory tract infection, and joint or muscle pain.

The most common side effects seen with GAZYVA in a study that included previously untreated FL patients were infusion-related reactions, low white blood cell count, upper respiratory tract infections, cough, constipation and diarrhea.

The most common side effects of GAZYVA in LN were upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion-related reactions, and neutropenia.

Before receiving GAZYVA, patients should talk to their doctor about:

  • Immunizations: Before receiving GAZYVA therapy, the patient should tell their healthcare provider if they have recently received or are scheduled to receive a vaccine. Patients who are treated with GAZYVA should not receive live vaccines.
  • Pregnancy: The patient should tell their doctor if they are pregnant, think that they might be pregnant, plan to become pregnant, or are breastfeeding. GAZYVA may harm their unborn baby. The patient should speak to their doctor about using GAZYVA while they are pregnant. The patient should talk to their doctor or their child’s doctor about the safety and timing of live virus vaccinations to their infant if they received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after your GAZYVA treatment.
  • Breastfeeding: Because of the potential risk of serious side reactions in breastfed children, patients should not breastfeed while taking GAZYVA and for 6 months after your last dose.

Patients should tell their doctor about any side effects.

These are not all of the possible side effects of GAZYVA. For more information, patients should ask their doctor or pharmacist.

GAZYVA is available by prescription only.

Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit https://www.GAZYVA.com for the GAZYVA full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.

About Genentech in Immunology

Genentech is committed to harnessing pioneering science and innovation to address critical unmet needs for patients with immune-mediated inflammatory diseases. Our pipeline includes over a dozen clinical programs in immunology aiming to transform care for people living with lupus, MASH, ulcerative colitis, Crohn’s disease, immunoglobulin A nephropathy, idiopathic nephrotic syndrome, atopic dermatitis, and rheumatoid arthritis. We are investing end-to-end in immunology from discovery to R&D to commercialization across a variety of modalities including monoclonal antibodies, bispecifics, and CAR-T cell therapies to help solve some of the most difficult challenges in immunology today.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact:

Kendall Tich

(650) 467-6800

Advocacy Contact:

Meg Harrison

(617) 694-7060

Investor Contacts:

Loren Kalm

(650) 225-3217

Bruno Eschli

+41 61 687 5284

Galderma Announces Appointment of New Chief Financial Officer

Galderma Announces Appointment of New Chief Financial Officer




Galderma Announces Appointment of New Chief Financial Officer

Ad hoc announcement pursuant to Art. 53 LR


ZUG, Switzerland–(BUSINESS WIRE)–Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced the appointment of Luigi La Corte as Chief Financial Officer (CFO), effective May 1, 2026.

Luigi La Corte will join Galderma on April 1 to begin a smooth and orderly transition with Thomas Dittrich, who has served as CFO of Galderma since October 2019. As previously announced, Thomas will remain with the company through Q2 2026 to ensure a seamless transition before pursuing another senior executive opportunity outside the organization.

 

“Luigi La Corte is an accomplished financial leader with deep experience across global healthcare and consumer organizations. I am delighted to welcome him to the Executive Committee and look forward to working with him closely as we continue to execute our Integrated Dermatology Strategy and extend our category leadership in dermatology. I would also like to thank Thomas for his commitment to ensuring a seamless transition and his many contributions to Galderma during his time with the company.”

 

FLEMMING ØRNSKOV, M.D., MPH

CHIEF EXECUTIVE OFFICER

GALDERMA

 

Luigi La Corte brings more than 30 years of international financial leadership experience across healthcare and consumer businesses. Most recently, he served as CFO of the global pharmaceutical company Recordati S.p.A from 2019 – 2025, where he was responsible for Group Finance, Investor Relations, Sustainability and Information Systems. He was appointed to Recordati’s Board of Directors in 2022, a position he continues to hold.

Previously, Luigi La Corte held a range of senior finance leadership roles within the pharmaceutical sector, including positions at GlaxoSmithKline, AstraZeneca and Alliance Unichem, and served as CFO at Pladis Food Group. Earlier in his career he also worked for Bain & Company, PepsiCo and Procter & Gamble. An Italian national, he holds a Master in Economics from Luiss University and is a Fellow of the Chartered Institute of Management Accountants.

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

Forward-looking statements

Certain statements in this announcement are forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “plans”, “targets”, “aims”, ” believes”, “expects”, “anticipates”, “intends”, “estimates”, “will”, “may”, “continues”, “should” and similar expressions. These forward-looking statements reflect, at the time, Galderma’s beliefs, intentions and current targets/ aims concerning, among other things, Galderma’s results of operations, financial condition, industry, liquidity, prospects, growth and strategies and are subject to change. The estimated financial information is based on management’s current expectations and is subject to change. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions, intense competition in the markets in which Galderma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Galderma’s markets, and other factors beyond the control of Galderma). Neither Galderma nor any of their respective shareholders (as applicable), directors, officers, employees, advisors, or any other person is under any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this announcement. Statements contained in this announcement regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. Some of the information presented herein is based on statements by third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, reasonableness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for any purpose whatsoever. Except as required by applicable law, Galderma has no intention or obligation to update, keep updated or revise this announcement or any parts thereof.

Contacts

For further information:

Media

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Richard Harbinson

Corporate Communications Director

richard.harbinson@galderma.com
+41 76 210 60 62

Investors

Emil Ivanov

Head of Strategy, Investor Relations and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43