Priority Review decision is based on phase III MAJESTY results, where Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years compared to tacrolimus 1 If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory...
The new test enables clinicians to reliably diagnose HDV and monitor patients’ treatment response. Hepatitis D affects nearly 12 million of people globally and is considered the most aggressive form of viral hepatitis, often leading to liver failure and cancer faster than other types....
The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress toward the World Health Organization's elimination targets. Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on...
Five oral presentations in a Featured Research Session will highlight trontinemab, including new long-term data from Phase Ib/IIa Brainshuttle TM AD study and design of Phase III PrevenTRON study in preclinical Alzheimer’s New data on Roche’s CE mark Elecsys pTau217 blood test will be presented on its use for Alzheimer's diagnosis in both primary and...
Phase III (Krascendo 1) demonstrates best-in-class potential for patients with previously treated advanced KRAS G12C non-small cell lung cancer Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors;...
The filing application is based on improvements seen across key efficacy endpoints from the global phase III SatraGO-1 and SatraGO-2 studies, including proptosis (bulging eyes) and diplopia (double vision) in active TED Enspryng (satralizumab) has the potential to become the first at-home subcutaneous disease-modifying standard of care for TED TED is an...
AXELIOS 1 delivers a unique combination of accuracy, speed, scalability and cost efficiency, giving laboratories of all sizes the freedom to customise their workflows and explore a wider array of applications....
Filing acceptance based on data from the phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death 1 People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies If approved, this...
The new VENTANA PTEN (SP218) RxDx Assay fulfils an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with TRUQAP In prostate cancer, PTEN protein loss is associated with faster disease progression and reduced benefit from current standard-of-care treatments 1 The FDA approval...
Filing acceptance is based on the phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone 1 Nearly one in three patients with stage III colon cancer relapse within five years, highlighting a critical need for new adjuvant treatment options 2,3 If approved, Tecentriq plus...
Agreement offers potential best-in-class targeted protein degrader therapy option for people living with B-cell malignancies Collaboration adds to Roche’s oncology pipeline and offers potential indications in immunology (chronic spontaneous urticaria) and neurology (multiple sclerosis) Bexobrutideg utilises a novel approach to eliminate the Bruton’s...
Filing acceptance, under priority review, based on phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy 1 Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years 1-3 Giredestrant has the potential to become a new...
Late-breaking Phase II data highlight enicepatide’s (CT-388) efficacy and safety, reinforcing its potential to deliver best-in-class weight loss across a broad population of people living with overweight or obesity Late-breaking data from the Phase II ZUPREME-1 trial showcase petrelintide’s efficacy, safety, and compelling tolerability profile, which has...
Roche introduces the first comprehensive library of certified healthcare algorithms to support chronic liver disease (CLD) management The Liver Disease Panel includes LiverPRO—a certified algorithm developed by the health tech company Evido—requiring only age and routine blood markers for the timely detection of liver fibrosis With CLD affecting 1.5 billion...
New giredestrant data from the lidERA study on its potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages Primary results from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease Overall,...
Elecsys® pTau217 is the first blood test for Alzheimer’s disease pathology with a single ‑ assay design, intended to rule in and rule out amyloid pathology across primary and secondary care, offering faster diagnosis for millions of patients around the world....
PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities will complement Roche's digital pathology portfolio to drive laboratory efficiency Combining Roche’s strong position in companion diagnostics and PathAI’s advanced AI platform helps accelerate clinical therapy development, foster the discovery of new...
New real-world data confirm Vabysmo’s potent retinal drying in nAMD and DME Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden Roche will present more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions Basel, 30 April 2026...
Group sales were +6% at constant exchange rates (CER) 1 , -5% when reported in CHF and +9% in USD 2 , in the first three months, driven by high demand for our innovative medicines and diagnostics....
Late-breaking Phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in relapsing multiple sclerosis (RMS) Both studies showed positive trends in reducing disability progression with fenebrutinib compared to teriflunomide Fenebrutinib could become a...
Phase III METEOROID study met its primary endpoint in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) MOGAD is a rare autoimmune disease of the central nervous system characterised by unpredictable attacks of the optic nerves, spinal cord or brain that are often severe and debilitating Data will be submitted to...
Filing acceptance based on phase III ALLEGORY data for Gazyva/Gazyvaro showing a significant reduction in disease activity compared with placebo in people with systemic lupus erythematosus (SLE) If approved, Gazyva/Gazyvaro would be the first anti-CD20 therapy to directly target B cells in SLE, potentially becoming the new standard of care for this...
The Elecsys NfL blood test detects neuroaxonal damage associated with neuroinflammation in adults diagnosed with relapsing remitting multiple sclerosis. 1 This minimally invasive blood test enables greater patient access to monitoring of neuroinflammatory status versus current standard of care methods....
The cobas MPX-E test provides four critical results (for HIV, HCV, HBV, and HEV) in a single test, increasing laboratory efficiency and decreasing healthcare costs. The new test delivers faster turnaround times and allows labs to implement Hepatitis E (HEV) screening without requiring additional instrumentation....
The new building is part of a CHF 1.4 billion site investment, reinforcing Roche’s commitment to Switzerland and the Basel life sciences cluster The Institute of Human Biology (IHB) enables scientists to pioneer human model systems, accelerating the development of new medicines to improve the lives of patients Federal Councillor Elisabeth Baume-Schneider,...