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Roche | MEDIA

Roche is a global healthcare company headquartered in Basel, Switzerland. It operates in two main areas: pharmaceuticals and diagnostics. Roche is known for its research and development in innovative medicines and diagnostic tools. Their pharmaceutical division focuses on treatments for a range of conditions including oncology, immunology, and neuroscience. The diagnostics division provides tools and tests for detecting diseases, managing health conditions, and personalizing patient care. Roche is recognized for its contributions to medical research and its commitment to improving healthcare outcomes worldwide.
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RSS Hunter RSS Hunter • Aug 19, 2024

Thread Of Notes

CHMP recommends EU approval of Roche’s Susvimo, the first continuous delivery treatment for neovascular age-related macular degeneration (nAMD)

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Susvimo for treating neovascular age-related macular degeneration (nAMD). This new treatment offers an alternative to standard monthly eye injections for patients. Susvimo utilizes a refillable implant called Contivue, which continuously delivers medication directly into the eye. Clinical studies, including Archway, LADDER, and Portal, demonstrated that Susvimo maintained vision equivalent to current monthly injections. With this implant, patients may only require two treatments per year, reducing the need for frequent clinic visits. nAMD is a significant cause of blindness in individuals over 60, affecting millions in the European Union. The Contivue implant system involves a one-time surgical procedure for insertion, along with ancillary devices for filling, refilling, and removal. Susvimo contains a customized formulation of ranibizumab, a VEGF inhibitor. Roche is exploring other molecules for potential use with the Port Delivery Platform to enhance efficacy and durability. The final decision on Susvimo's approval is expected from the European Commission soon.
https://www.roche.com/media/releases/med-cor-2026-07-24 roche.com
RSS Hunter RSS Hunter • Jul 24

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s strong momentum continues in the first half of 2026, delivering +6% sales growth at constant exchange rates; -2% in CHF due to the significant appreciation of the Swiss franc

Roche reported strong first-half results driven by demand for innovative medicines and diagnostics, with sales up 6% at constant exchange rates. The Pharmaceuticals Division saw growth from key drugs like Xolair, Hemlibra, and Ocrevus, while the Diagnostics Division benefited from increased demand for its products. Core operating profit rose 10% at constant exchange rates, though reported profits in Swiss francs were impacted by currency appreciation. Several drugs received US Priority Reviews for various cancers and autoimmune diseases, indicating significant pipeline progress. Positive Phase III data emerged for divarasib in lung cancer, and promising results were presented for other compounds in multiple sclerosis and obesity. The company also launched a new next-generation sequencing platform and received EU approval for Alzheimer's and tuberculosis tests. Acquisitions and collaborations, including a deal with Nurix Therapeutics and the planned purchase of PathAI, further bolster Roche's diagnostic capabilities. The company reaffirmed its 2026 outlook, expecting mid-single-digit sales growth and high-single-digit core earnings per share growth at constant exchange rates. This continued momentum positions Roche for sustained future growth and further dividend increases.
https://www.roche.com/media/releases/med-cor-2026-07-23 roche.com
RSS Hunter RSS Hunter • Jul 23

FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy

Roche announced that the FDA has granted Priority Review for Gazyva/Gazyvaro (obinutuzumab) to treat primary membranous nephropathy (pMN). This decision is based on positive Phase III MAJESTY study results, showing superior efficacy over tacrolimus in adults with pMN. Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years (36.9%) compared to tacrolimus (5.7%). If approved, Gazyva/Gazyvaro would be the first FDA-approved therapy for pMN, a chronic autoimmune kidney disease. Untreated pMN can lead to kidney failure in up to 30% of patients within ten years. The FDA has also granted Breakthrough Therapy Designation for Gazyva/Gazyvaro in pMN and expects an approval decision by November 2026. This is the second priority review for Gazyva/Gazyvaro this year, following idiopathic nephrotic syndrome. The drug targets tissue-resident B cells, addressing an underlying cause of pMN to help maintain kidney function. Safety results were consistent with Gazyva/Gazyvaro’s known profile. These data have been submitted to other global health authorities, including the European Medicines Agency.
https://www.roche.com/media/releases/med-cor-2026-07-15 roche.com
RSS Hunter RSS Hunter • Jul 15

Roche introduces cobas Hepatitis D Virus (HDV) test, the first fully automated diagnostic solution to identify the most severe form of viral hepatitis

Roche has introduced the cobas HDV test, a fully automated diagnostic tool for detecting and quantifying Hepatitis D Virus (HDV) RNA. This test is available for use on Roche's cobas 5800/6800/8800 systems in CE mark accepting countries. The cobas HDV test aims to address the urgent need for consistent and widely accessible HDV diagnostics. Hepatitis D is the most aggressive form of viral hepatitis, affecting nearly 12 million people globally. It often leads to severe liver damage, including liver failure and cancer, at a faster rate than other hepatitis types. The virus can only infect individuals who already have Hepatitis B. This can manifest as co-infection or a more dangerous super-infection. Previously, HDV testing was often limited to manual or inconsistent lab-developed methods. The new cobas HDV test is the first high-throughput, fully automated assay on the market, facilitating more effective patient identification and treatment monitoring. This advancement is particularly crucial as new treatments for HDV become available, requiring precise diagnostics for optimal patient care. The automated platforms allow for seamless integration into existing laboratory workflows, delivering accurate and timely results. This commitment from Roche aims to improve outcomes for individuals living with liver disease.
https://www.roche.com/media/releases/med-cor-2026-07-14 roche.com
RSS Hunter RSS Hunter • Jul 14

Roche receives CE Mark for blood test to identify tuberculosis infection

Roche has announced its Elecsys IGRA TB test has received CE Mark approval. This new blood test identifies tuberculosis infection (latent TB) in standard laboratory settings. The test offers rapid, efficient diagnosis with results available in under 24 hours. Processing time per patient is reduced to just 19 minutes, significantly faster than current methods. This automated solution runs on Roche's widely used cobas immunoassay systems, increasing laboratory throughput. The Elecsys IGRA TB test aims to improve accessibility and reduce reliance on manual workflows. It is a crucial step towards achieving the World Health Organization's global TB elimination targets. The test demonstrates high accuracy with excellent positive and negative agreement rates. It also offers a less invasive alternative to skin tests and is minimally affected by BCG vaccinations. Roche's integrated solution can work alongside existing assays for both latent and active TB.
https://www.roche.com/media/releases/med-cor-2026-07-09 roche.com
RSS Hunter RSS Hunter • Jul 9

Roche presents new data in Alzheimer’s disease from across its integrated pharmaceutical and diagnostics portfolio at AAIC

Roche will present new data from its Alzheimer's disease portfolio at the Alzheimer's Association International Conference in London on July 12-15. The data will demonstrate the company's progress in developing next-generation medicines and diagnostic tests for Alzheimer's disease. Five oral presentations will highlight trontinemab, including new long-term data from the Phase Ib/IIa Brainshuttle AD study and the design of the Phase III PrevenTRON study in preclinical Alzheimer's. Roche will also present data on its Elecsys pTau217 blood test, which recently received CE mark certification for use in Alzheimer's diagnosis. The company aims to bring together advanced diagnostics and transformative medicines to benefit Alzheimer's patients through earlier detection and intervention. Roche's Chief Medical Officer, Levi Garraway, stated that the company's goal is to slow, stop, or even prevent the progression of Alzheimer's disease. The company will also present data on its investigational therapeutic approaches, including NLRP3 inhibition, and its approved Elecsys pTau181 blood test for ruling out Alzheimer's disease. Roche is committed to addressing the global burden of Alzheimer's disease and partners with clinicians, scientists, patient advocates, policymakers, and health systems to ensure that advances in research translate into benefits for patients worldwide. The company's Alzheimer's disease portfolio spans several investigational medicines and diagnostics, including trontinemab, nivegacetor, and RG6627, as well as approved and investigational digital and blood-based tests. Roche's presentations at the conference will feature data from its expanding Alzheimer's disease portfolio, including investigational trontinemab, neuroinflammatory approaches, and blood-based diagnostics.
https://www.roche.com/media/releases/med-cor-2026-07-07 roche.com
RSS Hunter RSS Hunter • Jul 7

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer

Roche has announced positive results from the phase III Krascendo 1 study evaluating divarasib, an investigational next-generation KRAS G12C inhibitor, in patients with previously treated KRAS G12C non-small cell lung cancer. The study met its primary and key secondary endpoint, with divarasib achieving clinically meaningful and statistically significant improvements in both progression-free survival and overall survival. The safety profile for divarasib remained consistent with previous data, with no new findings detected and the most common treatment-related events being manageable and reversible. The results of the study demonstrate the potential of divarasib to improve clinical outcomes for people with KRAS G12C non-small cell lung cancer. The data from the Krascendo 1 study will be presented at an upcoming medical meeting and submitted to health authorities with the aim of bringing this potential treatment option to people with KRAS G12C NSCLC as soon as possible. The KRAS G12C mutation is one of the most common KRAS oncogene mutations, found in approximately 14% of NSCLC cases and associated with poor prognosis for patients. Roche is committed to advancing the field of lung cancer treatments, leveraging more than 20 years of deep scientific expertise to improve patient outcomes and their overall experience. The company has a comprehensive phase III clinical development programme in NSCLC, investigating divarasib as both a monotherapy and as a chemotherapy-free combination, across different disease settings and lines of therapy. The US Food and Drug Administration granted Breakthrough Therapy Designation to divarasib in 2022, and in 2026, Orphan Drug Designation for KRAS G12C non-small cell lung cancer. Overall, the results of the Krascendo 1 study are a significant step forward in the treatment of KRAS G12C non-small cell lung cancer, and Roche is committed to bringing this potential treatment option to patients as soon as possible.
https://www.roche.com/media/releases/med-cor-2026-07-02 roche.com
RSS Hunter RSS Hunter • Jul 2

FDA grants Priority Review to Roche’s Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED)

The U.S. Food and Drug Administration has accepted and granted priority review for Enspryng (satralizumab) for the treatment of thyroid eye disease. This decision is based on positive results from the global phase III SatraGO-1 and SatraGO-2 studies. These studies demonstrated consistent, clinically meaningful improvements in key efficacy endpoints for active thyroid eye disease. Specifically, Enspryng showed significant reductions in proptosis (bulging eyes) and improvements in diplopia (double vision). The drug's safety profile was consistent with its known profile in other conditions. Enspryng targets the underlying biology of thyroid eye disease, an autoimmune condition that can cause disfigurement and vision loss. If approved, Enspryng has the potential to be the first at-home subcutaneous disease-modifying standard of care for thyroid eye disease. The FDA is expected to make a decision on its approval by October 15, 2026. This represents an important step in expanding treatment options for patients with this debilitating condition.
https://www.roche.com/media/releases/med-cor-2026-06-30 roche.com
RSS Hunter RSS Hunter • Jun 30

Roche announces the launch of AXELIOS 1, a transformative next-generation sequencing platform

Roche has launched AXELIOS 1, a new single-molecule sequencing platform powered by proprietary SBX technology. This platform offers a unique combination of accuracy, speed, scalability, and cost efficiency for laboratories. AXELIOS 1 enables end-to-end, same-day whole-genome sequencing with results available in hours for research applications. The platform's flexible design allows it to handle studies of varying sizes, from small projects to massive genomic endeavors. Collaborations with institutions like Hartwig Medical Foundation and Broad Clinical Labs have validated its real-world capabilities. AXELIOS 1 also supports library preparation and analysis tools, including partnerships with 10x Genomics and Google DeepVariant. The SBX technology converts DNA/RNA into high signal-to-noise 'Xpandomers' for accurate sequencing. Roche will provide tailored library prep kits and an open-source bioinformatics analysis suite called XOOS. The technology has demonstrated potential across various research applications, including oncology and infectious diseases, and has achieved a world record for sequencing speed. AXELIOS 1 is currently for research use only and not for diagnostic procedures.
https://www.roche.com/media/releases/med-cor-2026-06-29 roche.com
RSS Hunter RSS Hunter • Jun 29

FDA accepts supplemental Biologics License Application for Roche’s Lunsumio and Polivy combination for people with relapsed or refractory large B-cell lymphoma

The US FDA has accepted Roche's supplemental Biologics License Application for Lunsumio VELO in combination with Polivy. This submission is for adult patients with relapsed or refractory large B-cell lymphoma (LBCL). The application is supported by data from the phase III SUNMO study. This combination demonstrated a significant 59% reduction in the risk of disease progression or death versus the R-GemOx regimen. Median progression-free survival was substantially longer with Lunsumio VELO and Polivy at 11.5 months compared to 3.8 months for R-GemOx. The safety profile of the combination was consistent with individual drug profiles, and cytokine release syndrome events were low. If approved, this outpatient-ready regimen could improve access to care in community settings. Relapsed or refractory LBCL represents a high unmet need in lymphoma treatment. The development signifies a potential important chemotherapy-free option for these patients. The FDA is expected to decide on approval by February 9, 2027.
https://www.roche.com/media/releases/med-cor-2026-06-18 roche.com
RSS Hunter RSS Hunter • Jun 18

Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer

Roche announced FDA approval for the VENTANA PTEN (SP218) RxDx Assay. This is the first immunohistochemistry companion diagnostic test for PTEN protein loss in prostate cancer. It identifies patients who may benefit from combination treatment with AstraZeneca's TRUQAP. PTEN protein loss is linked to faster disease progression and poorer outcomes with standard treatments. This approval marks a significant step in personalized healthcare for prostate cancer patients. TRUQAP offers a new first-line treatment option for PTEN-deficient metastatic prostate cancer. Previously, treatments specifically targeting this PTEN protein loss biology were unavailable. Approximately 25% of metastatic hormone-sensitive prostate cancer patients have PTEN-deficient tumors. Foundation Medicine is one laboratory utilizing this diagnostic kit. The assay's approval was based on the CAPItello-281 clinical study results.
https://www.roche.com/media/releases/med-cor-2026-06-12 roche.com
RSS Hunter RSS Hunter • Jun 12

FDA grants Priority Review for Roche’s Tecentriq for a certain type of stage III colon cancer

Roche announced the FDA accepted its filing for Tecentriq plus chemotherapy for stage III dMMR/MSI-H colon cancer. This acceptance is based on the Alliance ATOMIC study, which showed a significant reduction in recurrence or death risk. Nearly one in three stage III colon cancer patients relapse within five years, highlighting an urgent need for new treatments. If approved, Tecentriq plus chemotherapy could become a new standard of care for this specific patient group after surgery. The ATOMIC study, published in The New England Journal of Medicine, demonstrated a 50% reduction in recurrence or death by adding Tecentriq to standard chemotherapy. Disease-free survival at 36 months was 86% with Tecentriq and chemotherapy compared to 76% with chemotherapy alone. The safety profile remained consistent with previous findings for both treatments. Approximately 15% of colon cancers are dMMR/MSI-H, indicating a high mutation rate that can respond to immunotherapy. Roche is seeking further regulatory approvals globally for this potential new adjuvant therapy. This collaboration with academic groups underscores Roche's commitment to advancing cancer treatment.
https://www.roche.com/media/releases/med-cor-2026-06-11 roche.com
RSS Hunter RSS Hunter • Jun 11

Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology

Roche and Nurix Therapeutics have formed an exclusive licensing and collaboration agreement to co-develop and commercialize bexobrutideg, an investigational BTK degrader. This partnership aims to advance bexobrutideg as a best-in-class therapy for B-cell malignancies and explore its potential in immunology and neurology. Unlike current BTK inhibitors, bexobrutideg eliminates the BTK protein, potentially overcoming resistance mechanisms. The collaboration will include a clinical development plan across blood cancers, chronic spontaneous urticaria, and multiple sclerosis. Bexobrutideg's novel approach targets both kinase and scaffolding functions of BTK. The deal involves an upfront payment to Nurix and milestone payments, with shared development costs and profits. Roche's oncology pipeline is enhanced by this agreement, particularly in hematology. The global market for BTK-targeting drugs is projected to be substantial. Bexobrutideg is expected to enter Phase 3 trials for second-line CLL treatment this summer. This collaboration signifies a significant step in leveraging targeted protein degradation for patient benefit.
https://www.roche.com/media/releases/med-cor-2026-06-08 roche.com
RSS Hunter RSS Hunter • Jun 8

FDA accepts New Drug Application for Roche’s giredestrant in ER-positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting

The FDA has accepted Roche's New Drug Application for giredestrant, an investigational oral treatment for early-stage ER-positive, HER2-negative breast cancer. This acceptance is under Priority Review, indicating a potentially faster evaluation process. The decision is based on Phase III lidERA Breast Cancer study results. These results showed giredestrant reduced the risk of invasive disease recurrence or death by 30% compared to standard endocrine therapy. This represents a significant advance in adjuvant endocrine therapy in over two decades. Giredestrant has the potential to become a new standard of care, especially since most ER-positive breast cancers are diagnosed early. The FDA's decision is expected by November 30, 2026. Giredestrant works by degrading the estrogen receptor, thereby blocking cancer cell growth. The drug was also well-tolerated, with a lower discontinuation rate than standard treatment. Roche is committed to developing giredestrant for various breast cancer settings to improve patient outcomes.
https://www.roche.com/media/releases/med-cor-2026-06-02 roche.com
RSS Hunter RSS Hunter • Jun 2

Roche to present new data advancing its obesity portfolio at the American Diabetes Association’s 2026 Scientific Sessions

Roche announced promising late-breaking data from its obesity portfolio, set to be presented at the ADA 2026 Scientific Sessions. The data highlights the efficacy and safety of enicepatide (CT-388) and petrelintide. Enicepatide, a dual GLP-1/GIP receptor agonist, showed significant weight loss in a Phase II study. Petrelintide, an investigational amylin analog, demonstrated positive results in the ZUPREME-1 Phase II trial. Roche plans to initiate a Phase II multi-arm combination trial of enicepatide and petrelintide in mid-2026. These developments aim to offer tailored treatment options for people with overweight or obesity. The company emphasizes the potential of these drugs to improve long-term treatment adherence. Both compounds are advancing into Phase III development. More detailed findings will also be presented during a virtual event on June 8, 2026. The company is committed to addressing the global obesity crisis. Roche is also evaluating enicepatide in a study for patients with type 2 diabetes.
https://www.roche.com/media/releases/med-cor-2026-06-01 roche.com
RSS Hunter RSS Hunter • Jun 1

Roche launches the Liver Disease Panel, the first suite of certified algorithms to support Chronic Liver Disease management

Roche has released its Liver Disease Panel, a comprehensive suite of certified algorithms for chronic liver disease management. This panel includes LiverPRO, an algorithm requiring only age and common blood markers for fibrosis detection. The panel aims to improve early detection and management of chronic liver disease, a global health concern affecting 1.5 billion people. By combining biomarkers and algorithms, the panel supports informed clinical decisions across the patient pathway. The Liver Disease Panel will help in the early identification of risks and in providing proactive care. LiverPRO, developed with Evido, is endorsed as a first-line test by EASL. The Liver Disease Panel is available on the navify Algorithm Suite and integrates with existing hospital systems. Roche's investment in digital diagnostics aims to advance the standard of care in liver disease. The digital solutions are designed to standardize patient referrals.
https://www.roche.com/media/releases/med-cor-2026-05-27 roche.com
RSS Hunter RSS Hunter • May 27

Roche to present new data at ASCO 2026, reinforcing giredestrant's potential to transform the treatment paradigm in early breast cancer

Roche will present new data from nine approved and investigational medicines at the 2026 ASCO meeting. A major focus is giredestrant, an oral SERD, being tested for ER-positive, HER2-negative breast cancer. Data from the lidERA study will explore giredestrant's efficacy across menopausal stages in early breast cancer. The persevERA study revealed numerical improvements in progression-free survival with giredestrant plus palbociclib. Analyses of evERA will address sustained clinical benefit after progression on CDK4/6 inhibitors. Preliminary results will be shared for ZN-A-1041, a blood-brain barrier-permeable HER2 TKI in HER2-positive breast cancer. The Krascendo 170 study will present data on the KRAS G12C inhibitor divarasib combined with pembrolizumab in lung cancer. Updated findings from the SUNMO trial will support the effectiveness of Lunsumio plus Polivy in DLBCL. Roche's presentation also encompass a variety of innovative treatments for multiple types of cancer. The company is committed to addressing cancers with a high burden on patients and society.
https://www.roche.com/media/releases/med-cor-2026-05-19 roche.com
RSS Hunter RSS Hunter • May 19

Roche receives CE mark for new blood test to detect Alzheimer's pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217)

Roche has received CE Mark for Elecsys pTau217, a blood test for Alzheimer's disease pathology developed in collaboration with Eli Lilly. This test uses a single-assay design to measure the pTau217 protein, an indicator of amyloid pathology. The test aims to aid in earlier and more accessible Alzheimer's disease diagnosis. It offers a more convenient and less invasive alternative to current methods. The test's accuracy is comparable to spinal fluid diagnostics and PET-CT scans. A positive result indicates a high likelihood of amyloid pathology, guiding clinicians. A negative result suggests a low likelihood, potentially ruling out Alzheimer's. The test is designed for use in primary and secondary care. The launch marks a significant step towards earlier diagnosis and timely intervention.
https://www.roche.com/media/releases/med-cor-2026-05-12 roche.com
RSS Hunter RSS Hunter • May 12

Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics

Roche is acquiring PathAI, a digital pathology and AI-powered technology company, to enhance its digital pathology capabilities. This merger builds on a successful partnership established in 2021, focusing on AI-enabled companion diagnostics. The acquisition will integrate PathAI's technology, including its advanced Image Management System (IMS), within Roche's Diagnostics division. This integration aims to streamline laboratory workflows and accelerate the shift toward personalized healthcare. The collaboration seeks to enhance precision diagnosis of cancer and improve treatment regimens for patients. PathAI's AI-driven solutions will complement Roche's expertise in companion diagnostics, boosting biopharma services. This will foster the discovery of new biomarkers and novel diagnostic tools, increasing Roche's value to biopharma companies. The deal involves an upfront payment of USD 750 million plus potential milestone payments up to USD 300 million. This acquisition will expand Roche's global reach in the rapidly growing digital pathology market.
https://www.roche.com/media/releases/med-cor-2026-05-07 roche.com
RSS Hunter RSS Hunter • May 7

Roche to present extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026

Roche will present significant ophthalmology data at the ARVO Annual Meeting, highlighting their commitment to vision preservation. Real-world evidence from the VOYAGER study will showcase Vabysmo's efficacy in drying retinas for nAMD and DME patients. These findings demonstrate consistent improvements in both treatment-naïve and previously treated individuals. The company will also present new data for Susvimo, emphasizing its potential for long-lasting disease control with reduced treatment burden. Additionally, early insights into the investigational IL-6 inhibitor, vamikibart, will be shared. These presentations cover a range of retinal conditions including geographic atrophy and uveitic macular edema. Roche is showcasing over 45 abstracts, with 20 oral presentations, underlining their broad ophthalmology pipeline. Vabysmo, a bispecific antibody, targets Ang-2 and VEGF-A pathways to stabilize blood vessels. Susvimo utilizes a refillable implant for continuous ranibizumab delivery. Vamikibart is an investigational antibody targeting IL-6 for inflammatory retinal conditions.
https://www.roche.com/media/releases/med-cor-2026-04-30 roche.com
RSS Hunter RSS Hunter • Apr 30

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong sales growth of +6% at constant exchange rates in the first quarter of 2026; -5% in CHF due to the significant appreciation of the Swiss franc

Roche reported a strong start to the year with group sales up 6% at constant exchange rates. Pharmaceuticals Division saw a 7% increase in sales at CER, driven by strong growth in key medicines. Diagnostics Division sales rose 3% at CER, despite headwinds from China's healthcare reforms. Several products like Xolair and Hemlibra were significant growth drivers. Roche highlighted positive clinical data for various treatments, including those for multiple sclerosis and obesity. A new Elecsys NfL blood test was approved, and the cobas MPX-E assay was launched. The company entered an agreement to acquire SAGA Diagnostics to enhance their oncology diagnostics. Roche's CEO expressed confidence in sustained future growth. The company confirmed its 2026 outlook, expecting mid-single-digit sales growth at CER. They also aim for core earnings per share growth in the high single digits (CER) and plan to increase the dividend. Key geographical regions showed varying sales performance, with the U.S. and Japan performing well. Positive data was announced for various drug trials in breast cancer, lupus, obesity, and multiple sclerosis.
https://www.roche.com/media/releases/med-cor-2026-04-23 roche.com
RSS Hunter RSS Hunter • Apr 23

Roche’s fenebrutinib significantly reduced relapses versus standard of care to approximately one every 17 years in RMS

Roche announced positive results from Phase III FENhance 1 and 2 studies of fenebrutinib in relapsing multiple sclerosis (RMS). The studies demonstrated fenebrutinib's superiority over teriflunomide in reducing annualized relapse rates and brain lesions. Fenebrutinib reduced relapse rates by over 50% compared to teriflunomide and significantly decreased brain disease activity. Positive trends were observed in reducing disability progression with fenebrutinib in both studies. Liver enzyme elevations were comparable between fenebrutinib and teriflunomide, although there were more deaths in the fenebrutinib arm. Fenebrutinib is a novel BTK inhibitor that targets both relapsing and progressive aspects of MS. A previous study, FENtrepid, showed non-inferiority of fenebrutinib versus OCREVUS in primary progressive MS (PPMS). Fenebrutinib could potentially be a first-in-class oral treatment option for both RMS and PPMS. Roche plans to submit the complete data from all three Phase III studies to regulatory authorities.
https://www.roche.com/media/releases/med-cor-2026-04-21c roche.com
RSS Hunter RSS Hunter • Apr 21

Roche’s ENSPRYNG (satralizumab) reduces risk of relapses by 68% demonstrating potential to become first treatment for MOGAD

The Phase III METEOROID study showed ENSPRYNG significantly reduced the risk of relapse in adults and adolescents with MOGAD. ENSPRYNG demonstrated a 68% reduction in the risk of new relapses compared to placebo, meeting its primary endpoint. The primary endpoint focused on the time to the first MOGAD relapse during the study's double-blind period. ENSPRYNG also reduced the annualized relapse rate by 66% and reduced CNS inflammation and the use of rescue therapies. The study observed an 87% relapse-free rate with ENSPRYNG at 48 weeks, compared to 67% with placebo. No new safety signals were reported, and the safety profile aligned with existing data from other studies. The data from METEOROID will be submitted to regulatory authorities worldwide for review. MOGAD is a rare autoimmune disease affecting the CNS, with no approved treatment options currently available. ENSPRYNG is a humanized monoclonal antibody targeting IL-6 receptor activity, offering a potential new treatment. Roche is pursuing other neurological autoimmune and inflammatory diseases for ENSPRYNG development.
https://www.roche.com/media/releases/med-cor-2026-04-21b roche.com
RSS Hunter RSS Hunter • Apr 21

FDA accepts application for Roche’s Gazyva/Gazyvaro for the treatment of the most common form of lupus

Roche announced the FDA has accepted its application for Gazyva/Gazyvaro for systemic lupus erythematosus (SLE), based on positive phase III ALLEGORY data. The ALLEGORY study showed Gazyva/Gazyvaro significantly reduced disease activity compared to placebo, measured by the SRI-4 at 52 weeks. The FDA is expected to make an approval decision by December 2026. Gazyva/Gazyvaro is already approved for lupus nephritis in the US and EU. The study also demonstrated improvements in secondary endpoints, like BICLA response and glucocorticoid reduction. Patients on Gazyva/Gazyvaro were less likely to experience flares and showed higher remission rates. The safety profile of Gazyva/Gazyvaro was consistent with previous findings. Gazyva/Gazyvaro targets B cells, and could become a new standard of care for SLE, affecting millions. The ALLEGORY data has also been submitted to the European Medicines Agency for review. This treatment offers hope for better disease control and reducing the burden of long-term steroid use.
https://www.roche.com/media/releases/med-cor-2026-04-21 roche.com
RSS Hunter RSS Hunter • Apr 21

Roche receives CE mark for new Elecsys NfL blood test to detect neuroinflammation in multiple sclerosis

Roche announced CE mark approval for its Elecsys NfL blood test intended for detecting neuroinflammation in relapsing remitting multiple sclerosis (RRMS) patients. This test monitors neuroaxonal damage by measuring neurofilament light chain (NfL) levels in a simple blood sample. The test offers a less invasive alternative to traditional methods like MRI for monitoring MS disease activity. Elecsys NfL provides insights into neuroinflammatory activity, potentially enabling earlier clinical intervention and better disease management. This technology complements routine assessments and could improve access to regular monitoring for more patients. The Elecsys NfL test yields consistent results and can be performed locally, reducing patient travel. NfL, a protein released during nerve cell injury, serves as a sensitive indicator of neuroaxonal damage. The Elecsys NfL test offers a standardised method for consistent monitoring. Roche aims to advance diagnostics and treatments for people with neurological disorders, including MS.
https://www.roche.com/media/releases/med-cor-2026-04-13 roche.com
RSS Hunter RSS Hunter • Apr 13

Roche launches the cobas MPX-E assay, a new 4-in-1 donor screening test to further safeguard the global blood supply

The cobas MPX-E assay, launched by Roche, is a single test detecting HIV, HCV, HBV, and HEV, enhancing lab efficiency. This multiplex real-time PCR test offers faster turnaround times and facilitates Hepatitis E screening without new instruments. The assay is designed for the high-throughput cobas x800 systems, allowing up to eight hours of walk-away time. The test improves blood safety by identifying these crucial viral pathogens simultaneously in a single workflow. It addresses the high global incidence of HEV infections, aiming to prevent transmission through blood transfusions. Dual-target detection in the assay ensures reliable HIV-1 group M results, even with mutations. The cobas MPX-E assay is targeting the Nucleic Acid Testing (NAT) market, which is a significant global market. The assay also has flexible testing options, allowing single or all four targets to be run. Laboratories screening for HEV will benefit from quicker results. Safe blood product access is a key goal.
https://www.roche.com/media/releases/med-cor-2026-03-30 roche.com
RSS Hunter RSS Hunter • Mar 30

Roche inaugurates new research home for the Institute of Human Biology, pioneering human model systems to accelerate drug discovery and development

Roche is inaugurating its Institute of Human Biology (IHB) in Basel, a key step in its drug discovery strategy. This new research facility, part of a larger CHF 1.4 billion investment, signifies Roche's commitment to Switzerland. The IHB will focus on advanced human model systems to accelerate medicine development. Scientists will use models like organoids and AI to better understand and combat human diseases. The institute aims to make research more predictive and efficient, improving patient outcomes. Building 92, the IHB's home, will house up to 250 researchers in a collaborative environment. Roche has invested significantly in Swiss research and development, totaling around CHF 41 billion since 2016. The IHB's multidisciplinary approach will bridge fundamental and industry sciences. The official opening ceremony will be attended by Federal Councillor Elisabeth Baume-Schneider. The goal is to translate scientific breakthroughs into patient-focused solutions more quickly.
https://www.roche.com/media/releases/med-cor-2026-03-23 roche.com
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RSS Hunter RSS Hunter • Mar 23

Roche launches NVIDIA AI factory to accelerate the development of new therapeutics and diagnostics solutions

Roche has significantly expanded its AI infrastructure with 2,176 new NVIDIA Blackwell GPUs, creating the largest announced hybrid-cloud AI factory in the pharmaceutical industry. This addition brings Roche's total GPU count to over 3,500, supporting its goal of an AI-accelerated healthcare organization. This investment builds upon a strategic collaboration with NVIDIA to advance drug development and improve healthcare outcomes. The AI factory integrates AI across the entire value chain, from research and development to manufacturing and commercialization. Roche utilizes NVIDIA's BioNeMo platform for research acceleration and insights. Digital twins built with NVIDIA Omniverse optimize manufacturing processes. The company also employs accelerated computing for diagnostics and digital pathology, improving image analysis. Roche uses NVIDIA NeMo Guardrails to ensure safe and reliable healthcare-grade conversational AI. This expansion strengthens Roche's leadership in AI-driven drug discovery and development. The initiative aims to shorten the path from scientific insights to life-saving medicines. This AI factory investment is a cornerstone of Roche's broader digital transformation.
https://www.roche.com/media/releases/med-cor-2026-03-16 roche.com
RSS Hunter RSS Hunter • Mar 16

Roche Annual General Meeting 2026

Roche shareholders approved all proposals at their Annual General Meeting held on March 10, 2026. Severin Schwan was re-elected as Chairman with a high percentage of the vote. The meeting approved the financial statements, remuneration report, and sustainability report for 2025. A dividend increase to CHF 9.80 per share was also approved, marking the 39th consecutive increase. Shareholders authorized the discharge of the Board of Directors and Corporate Executive Committee members. The meeting approved the total bonuses for the Corporate Executive Committee for the 2025 year. All other board members were re-elected, and Lubomira Rochet was newly elected to the Board. Shareholders also approved the appointment of KPMG AG as auditors for 2026. A key decision was the approval of exchanging Genussscheine for Participation Certificates. The Participation Certificates will be listed on the SIX Swiss Exchange with a new ticker symbol. Shareholders holding printed certificates were advised to convert them to intermediated securities.
https://www.roche.com/media/releases/med-cor-2026-03-10 roche.com
RSS Hunter RSS Hunter • Mar 10

[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on phase III persevERA study in ER-positive advanced breast cancer

The persevERA study of giredestrant and palbociclib in advanced breast cancer did not meet its primary goal but showed numerical improvement. Giredestrant in the combination was well-tolerated, with side effects aligning with known profiles. Roche is focusing on transforming ER-positive breast cancer treatment, referencing successful results from evERA and lidERA trials. The FDA has accepted a New Drug Application based on evERA data and will receive lidERA data soon. The pionERA study is planned for 2027 in endocrine-resistant breast cancer patients. Giredestrant is designed to block estrogen and inhibit cancer cell growth. The giredestrant clinical development program encompasses multiple trials spanning various stages of breast cancer. The early-stage lidERA trial and the advanced stage evERA trials provide evidence for giredestrant's clinical benefits. The full persevERA results will be presented at a forthcoming medical meeting. Roche aims to identify patients who would gain most from giredestrant treatment.
https://www.roche.com/media/releases/med-cor-2026-03-09 roche.com
RSS Hunter RSS Hunter • Mar 9

New England Journal of Medicine publishes phase III ALLEGORY data showing Roche’s Gazyva/Gazyvaro significantly reduces disease activity in the most common form of lupus

Roche announced positive results from the phase III ALLEGORY trial of Gazyva/Gazyvaro for systemic lupus erythematosus (SLE). The study showed significant improvement in SLE patients using Gazyva/Gazyvaro plus standard therapy compared to placebo. Over 76% of patients on Gazyva/Gazyvaro achieved a significant improvement in their SLE symptoms. Gazyva/Gazyvaro also demonstrated superiority in secondary endpoints, like time to first flare and remission rates improving them. If approved, Gazyva/Gazyvaro could become the first Type II anti-CD20 therapy for SLE, targeting B cells. The treatment showed a consistent safety profile, with no new safety signals identified. Data is being shared with health authorities to expedite access to this potential new treatment. The ALLEGORY study is a major success in SLE treatment, potentially reducing reliance on steroids. SLE affects millions worldwide, underlining the need for better treatments. Roche is investing in immunology and immune-mediated diseases to improve patient care.
https://www.roche.com/media/releases/med-cor-2026-03-06 roche.com
RSS Hunter RSS Hunter • Mar 6

Roche announces positive Phase II results for petrelintide, an amylin analog developed for people living with overweight and obesity

Roche announced positive Phase II trial results for petrelintide, an investigational weight-loss drug. The ZUPREME-1 trial showed significant weight loss in participants with overweight and obesity over 42 weeks. Participants taking petrelintide achieved up to 10.7% mean weight loss, compared to 1.7% with a placebo. The drug demonstrated a favorable tolerability profile, similar to the placebo, with few discontinuations due to adverse events. Gastrointestinal-related events were the most frequent, but mostly mild. The study met its primary endpoint, highlighting petrelintide's potential in chronic weight management. The data support further development, which will inform Phase III trial designs. Roche will present full trial data at an upcoming medical congress. Another Phase II trial for petrelintide in type 2 diabetes patients is expected in the second half of 2026. A combination trial with CT-388 will be initiated later in 2026. Roche is committed to advancing solutions for obesity and its related health problems.
https://www.roche.com/media/releases/med-cor-2026-03-05 roche.com
RSS Hunter RSS Hunter • Mar 5

[Ad hoc announcement pursuant to Art. 53 LR] Roche's fenebrutinib confirms its potential as first and only BTK inhibitor for relapsing and primary progressive MS in third positive Phase III study (FENhance 1)

Roche announced positive results from the FENhance 1 Phase III study of fenebrutinib in relapsing multiple sclerosis (RMS). Fenebrutinib significantly reduced relapses by 51% compared to teriflunomide, mirroring the FENhance 2 study's 59% reduction. These results, alongside FENtrepid data in primary progressive MS, will be submitted to regulators. Fenebrutinib, a BTK inhibitor, aims to be the first high-efficacy oral treatment for both RMS and PPMS. The drug targets B cells and microglia to address both acute inflammation and chronic damage. Secondary endpoints in both RMS studies showed significant reductions in brain lesions, and progression endpoints showed favorable trends. Full data will be presented at the AAN Annual Meeting 2026. The therapy has shown a favorable safety profile, with liver transaminase elevations similar to teriflunomide. The studies involved over 1,400 RMS patients comparing fenebrutinib to teriflunomide, with the primary endpoint being the annualised relapse rate.
https://www.roche.com/media/releases/med-cor-2026-03-02 roche.com
RSS Hunter RSS Hunter • Mar 2

FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer

Roche announced the FDA has accepted its New Drug Application for giredestrant plus everolimus. This combination is for adult patients with ER-positive, HER2-negative, ESR1-mutated advanced breast cancer. The FDA’s decision is expected by December 18, 2026. The filing is based on Phase III evERA data. Giredestrant plus everolimus reduced the risk of disease progression or death by 44% in the ITT population. In the ESR1-mutated population, the risk reduction was 62%. Overall survival data showed a positive trend. The combination's adverse events were manageable and consistent with known safety profiles. It could be the first oral SERD approved in the post-CDK4/6 inhibitor setting. The evERA study aimed to help address resistance to endocrine therapies. Further data from other trials will provide additional evidence. The company's development program seeks to provide innovative medicines for ER-positive breast cancer.
https://www.roche.com/media/releases/med-cor-2026-02-20 roche.com
RSS Hunter RSS Hunter • Feb 20

Change to the Roche Enlarged Corporate Executive Committee

Roche announced Mark Dawson, M.D., Ph.D., will lead Roche Pharma Research and Early Development (pRED) starting May 1, 2026. Dawson is a distinguished physician-scientist with extensive experience in cancer biology. He joins Roche from the Peter MacCallum Cancer Centre where he served as Associate Director of Research. His research focuses on chromatin regulation and epigenetics, crucial for understanding cancer. Dawson also holds a professorial appointment at the University of Melbourne. He is recognized by multiple scientific academies in Australia and Europe. Dawson's accolades include the Prime Minister’s Prize for Science and the Paul Marks Prize for Cancer Research. His background as a clinician-researcher is expected to drive innovation at Roche pRED. Roche, founded in 1896, is a global leader in biotechnology and diagnostics, committed to personalized healthcare.
https://www.roche.com/media/releases/med-cor-2026-02-17 roche.com
RSS Hunter RSS Hunter • Feb 17

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

The MAJESTY phase III study in primary membranous nephropathy met its primary endpoint, demonstrating Gazyva/Gazyvaro achieved complete remission at two years. This marks a significant advancement as up to 30% of patients with this condition progress to kidney failure. Gazyva/Gazyvaro, an anti-CD20 monoclonal antibody, has shown promise in various autoimmune and kidney diseases. The study found Gazyva/Gazyvaro superior to tacrolimus in achieving complete remission. Furthermore, it demonstrated clinical benefits in overall remission and earlier complete remission rates. These positive results could lead to Gazyva/Gazyvaro becoming the first approved treatment specifically for primary membranous nephropathy. Primary membranous nephropathy is a serious autoimmune condition affecting kidney function and potentially leading to kidney failure. Achieving complete remission is crucial for preserving kidney function and preventing severe complications. The MAJESTY study's findings will be presented to health authorities for potential approval. This represents Roche's ongoing commitment to developing innovative treatments for kidney-related diseases.
https://www.roche.com/media/releases/med-cor-2026-02-16 roche.com
RSS Hunter RSS Hunter • Feb 16

Roche’s fenebrutinib is the first investigational medicine in over a decade that reduces disability progression in primary progressive multiple sclerosis (PPMS)

Late-breaking Phase III FENtrepid study results show the investigational oral, brain-penetrant Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib met its primary endpoint of non-inferiority compared to OCREVUS (ocrelizumab) in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS). Fenebrutinib, a potential first-in-class treatment for PPMS and relapsing multiple sclerosis (RMS), numerically reduced the risk of disability progression by 12% compared to OCREVUS, the only previously approved medicine for PPMS. The primary endpoint measured the time to onset of 12-week composite confirmed disability progression (cCDP12), which includes metrics for functional disability, walking speed, and upper limb function. A consistent treatment effect was observed across patient subgroups, with the strongest effect being a 26% reduction in the risk of worsening upper limb function as measured by the nine-hole peg test (9HPT). A post-hoc analysis further demonstrated that fenebrutinib was superior to OCREVUS on a composite endpoint including EDSS and 9HPT, showing a 22% risk reduction. Common adverse events were comparable between fenebrutinib and OCREVUS, although transient and reversible liver enzyme elevations were more frequent with fenebrutinib. Fenebrutinib is designed to target both acute inflammation by inhibiting B cells and chronic damage by targeting microglia within the central nervous system. Regulatory submission for fenebrutinib in both PPMS and RMS is planned following the readout of the second pivotal RMS study, FENhance 1, expected in the first half of 2026. This data represents a potential scientific breakthrough for the PPMS community, offering a meaningful clinical benefit versus the current standard of care.
https://www.roche.com/media/releases/med-cor-2026-02-07 roche.com
RSS Hunter RSS Hunter • Feb 7

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2025 results with 7% sales growth

Roche reported a strong 2025 with group sales growing by 7% at constant exchange rates, driven by robust demand for medicines and diagnostics. The Pharmaceuticals Division saw a 9% increase, with key drugs like Phesgo and Vabysmo leading growth. The Diagnostics Division achieved a 2% sales increase, despite challenges in China. Core operating profit rose by 13%, reflecting higher sales and efficiency improvements. Core earnings per share grew by 11%, and IFRS net income significantly increased by 58%. Several new drug approvals and positive clinical trial data, particularly for breast cancer and multiple sclerosis, highlight pipeline strength. Diagnostics also saw advancements with new tests for dengue and vaginitis. The company plans to increase its dividend for the 39th consecutive year. Looking ahead, Roche anticipates mid-single-digit sales growth and high-single-digit core EPS growth in 2026. A new board member with digital and technology expertise is proposed for election.
https://www.roche.com/media/releases/med-cor-2026-01-29 roche.com
RSS Hunter RSS Hunter • Jan 29

[Ad hoc announcement pursuant to Art. 53 LR] Roche announces positive Phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity

Roche announced positive topline results from CT388-103, a Phase II clinical trial of CT-388, an investigational once-weekly dual GLP-1/GIP receptor agonist for treating obesity. At the highest 24 mg dose, CT-388 achieved a statistically and clinically significant placebo-adjusted weight loss of 22.5% at 48 weeks without reaching a plateau. This robust efficacy resulted in 54% of participants on the 24 mg dose achieving resolution of obesity, compared to 13% in the placebo group. The treatment also showed a clear dose-response relationship, with high percentages of participants achieving substantial weight loss thresholds, including 95.7% losing 5% or more of their body weight. Furthermore, 73% of pre-diabetic participants on the 24 mg dose achieved normal blood glucose levels at week 48, versus 7.5% in the placebo group. CT-388 demonstrated a safety and tolerability profile consistent with its drug class, with the majority of gastrointestinal adverse events being mild-to-moderate and a low discontinuation rate due to adverse events. Roche is highly confident in the drug's potential, reinforcing this by advancing CT-388—a fast-track asset—to Phase III clinical trials, expected to begin this quarter. The dual GLP-1/GIP mechanism aims to reduce appetite and regulate blood sugar via biased signaling to prolong pharmacological activity. Obesity is a major global health risk, projected to affect over four billion people by 2035, highlighting the need for transformative treatments like CT-388. Roche is accelerating the development of CT-388, which is also being investigated in an additional Phase II study and considered a combination therapy asset.
https://www.roche.com/media/releases/med-cor-2026-01-27 roche.com
RSS Hunter RSS Hunter • Jan 27

FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma

Roche announced FDA approval of Lunsumio VELO (mosunetuzumab) for relapsed or refractory follicular lymphoma. This subcutaneous formulation reduces administration time to approximately one minute, a significant improvement. The approval is based on the GO29781 study showing high complete response rates in patients with third-line or later disease. Lunsumio VELO is approved under accelerated approval, with full approval pending confirmatory trial results. The drug's manageable cytokine release syndrome profile is an advantage for delivery in community settings. The study results include 75% objective response and 59% complete response rates. Common adverse reactions included injection site reactions and fatigue. This approval broadens access to effective treatments for those living with follicular lymphoma. Lunsumio VELO's fixed-duration treatment contrasts with potentially indefinite "treat-to-progression" options. Roche is also studying Lunsumio and Lunsumio VELO in earlier lines of treatment. This is a step in improving care for those with this chronic disease.
https://www.roche.com/media/releases/med-cor-2025-12-22 roche.com
RSS Hunter RSS Hunter • Dec 22, 2025

Roche expands automated mass spectrometry menu with antibiotics drug monitoring CE mark approval offering industry’s broadest in vitro diagnostic menu

Roche secured CE Mark approval for its mass spectrometry reagent pack, expanding its in-vitro diagnostics menu. This makes Roche's offering the broadest available for any automated mass spectrometry platform, with 39 tests now. The tests include therapeutic drug monitoring for antibiotics, immunosuppressants, steroid hormones, and vitamin D metabolites. This automated solution replaces manual processes, improving turnaround times and standardizing care. The comprehensive menu allows clinicians to make quicker and more precise diagnoses. The cobas Mass Spec solution can integrate with Roche’s existing laboratory systems for streamlined workflows. Roche's solution has received "moderate complexity" categorization in the US, broadening its clinical utility. Roche is committed to expanding this menu further in the coming years. The technology provides the sensitivity and specificity of gold-standard testing.
https://www.roche.com/media/releases/med-cor-2025-12-11 roche.com
RSS Hunter RSS Hunter • Dec 11, 2025

Roche’s giredestrant reduced risk of invasive disease recurrence or death by 30% in ER-positive early-stage breast cancer

Roche announced positive results from the lidERA phase III study evaluating giredestrant in early-stage, ER-positive, HER2-negative breast cancer. Giredestrant, an oral SERD, showed a 30% reduction in the risk of invasive disease recurrence or death compared to standard endocrine therapy. This data will be presented at the 2025 San Antonio Breast Cancer Symposium. At three years, 92.4% of patients on giredestrant were disease-free versus 89.6% on standard therapy. The iDFS benefit was consistent across all subgroups, and a positive overall survival trend was observed. Giredestrant also reduced the risk of distant recurrence by 31% and was well-tolerated. ER-positive breast cancer is common, and recurrence after adjuvant therapy is a significant concern. Giredestrant aims to become a new standard of care in the early-stage setting. The lidERA trial enrolled over 4,100 patients, with iDFS being the primary endpoint. Roche is committed to developing giredestrant across multiple treatment settings.
https://www.roche.com/media/releases/med-cor-2025-12-10 roche.com
RSS Hunter RSS Hunter • Dec 10, 2025

Roche launches new PCR test to help improve diagnostic accuracy for women affected by vaginitis in countries following the CE Mark

Roche has launched a new PCR test, cobas BV/CV, to diagnose bacterial vaginosis (BV) and candida vaginitis (CV) accurately. This test identifies specific bacteria and yeast in vaginal samples, improving diagnostic accuracy. The test offers faster diagnosis using a single swab for broader sexual health testing, streamlining the process. Traditional methods often result in inaccurate diagnoses, leading to delayed or inappropriate treatment. The cobas BV/CV assay delivers precise results, allowing for quicker, targeted therapies. Bacterial vaginosis affects roughly 25% of women, while candida vaginitis impacts up to 75% at some point in their lives. These conditions, causing uncomfortable symptoms, can also increase STI risks. The global sexual health market, with vaginitis as a primary driver, is experiencing significant growth. The cobas BV/CV test expands Roche's sexual health portfolio, enabling efficient testing on the cobas 5800/6800/8800 systems. The test is now available in countries accepting the CE Mark.
https://www.roche.com/media/releases/med-cor-2025-12-09b roche.com
RSS Hunter RSS Hunter • Dec 9, 2025

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

The European Commission has approved Gazyva/Gazyvaro in combination with mycophenolate mofetil for treating adult patients with active lupus nephritis. This approval follows positive results from the phase II NOBILITY and phase III REGENCY studies, demonstrating Gazyva/Gazyvaro's superiority over standard therapy alone. The REGENCY study showed a higher rate of complete renal response in patients treated with Gazyva/Gazyvaro. The drug also led to a reduction in corticosteroid use and improvements in disease markers. Gazyva/Gazyvaro is the only anti-CD20 antibody to show a benefit in complete renal response in a randomized phase III lupus nephritis study. It has the potential to become a new standard of care for approximately 135,000 people in the EU affected by this condition. Lupus nephritis is a serious disease that can lead to end-stage kidney disease, requiring dialysis or transplant. This approval in the EU follows a similar approval in the United States. Gazyva/Gazyvaro is also being investigated for other autoimmune diseases. The drug is a monoclonal antibody targeting CD20, a protein on certain B cells.
https://www.roche.com/media/releases/med-cor-2025-12-09 roche.com
RSS Hunter RSS Hunter • Dec 9, 2025

Roche presents Lunsumio data showing potential across earlier treatment lines in indolent and aggressive lymphomas

New data presented at the 67th American Society of Hematology Annual Meeting highlight Lunsumio's potential for earlier lymphoma treatment. Preliminary data suggest Lunsumio combined with lenalidomide shows promise for relapsed or refractory follicular lymphoma. This combination demonstrated a high complete response rate in a US extension of the CELESTIMO study. Cytokine release syndrome and neutropenia were noted as manageable side effects. Long-term follow-up data from the GO40516 study revealed improved outcomes for Lunsumio subcutaneous plus Polivy in relapsed or refractory large B-cell lymphoma. This combination also showed benefits in quality of life compared to standard treatment regimens. Furthermore, five-year follow-up data from the GO29781 study indicated durable responses with Lunsumio in relapsed/refractory follicular lymphoma. Three-year follow-up data also support durable responses with subcutaneous Lunsumio in this patient group. These findings underscore Lunsumio's potential to offer improved, chemotherapy-free outpatient treatment options. Roche continues to explore innovative combinations of Lunsumio to enhance patient outcomes across various lymphoma types and stages.
https://www.roche.com/media/releases/med-cor-2025-12-08b roche.com
RSS Hunter RSS Hunter • Dec 8, 2025

Roche’s Columvi combination shows sustained survival benefit at three-year follow up of pivotal phase III STARGLO study

Roche announced promising three-year follow-up data from the STARGLO study for relapsed or refractory DLBCL patients. Columvi in combination with GemOx demonstrated significantly longer overall survival (OS) compared to MabThera/Rituxan plus GemOx. The OS rate was double for patients treated with the Columvi combination, suggesting a potential curative effect. Benefits were consistent across different patient subgroups, with the greatest advantage seen in second-line patients. The safety profile remained consistent, with cytokine release syndrome as the most common adverse event. This Columvi combination is now approved in over 50 countries and included in international treatment guidelines. It offers an off-the-shelf and fixed-duration therapy, potentially avoiding treatment delays. Roche is also exploring Columvi's potential in first-line DLBCL and mantle cell lymphoma. The STARGLO study evaluated this combination's efficacy and safety in patients ineligible for transplant. The study showed positive results regarding progression-free survival.
https://www.roche.com/media/releases/med-cor-2025-12-08 roche.com
RSS Hunter RSS Hunter • Dec 8, 2025

Roche receives FDA clearance with CLIA waiver and CE Mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis)

Roche has received FDA 510(k) clearance and CLIA waiver for its new point-of-care test for Bordetella infections, including whooping cough. This innovative PCR test, utilized with the cobas® liat system, delivers accurate results in just 15 minutes. This rapid diagnosis allows healthcare providers to take immediate action, preventing severe complications and the spread of the illness. The test uniquely differentiates between three Bordetella species, ensuring precise identification of the cause of respiratory symptoms. Early and accurate diagnosis is particularly crucial for vulnerable populations like infants and the elderly. Whooping cough, a significant public health concern, is currently experiencing a surge exacerbated by vaccination interruptions. The test's ability to diagnose during a single consultation reduces reliance on central labs and speeds up treatment decisions. This advancement complements existing assays for other respiratory pathogens on the cobas® liat platform. Roche aims to transform healthcare delivery through pioneering diagnostics and medicines for better patient outcomes. The test's speed and accuracy are vital in combating the challenges posed by Bordetella infections.
https://www.roche.com/media/releases/med-cor-2025-12-02 roche.com
RSS Hunter RSS Hunter • Dec 2, 2025

European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma

The European Commission has granted conditional marketing authorization for Lunsumio subcutaneous (SC) for adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies. This approval stems from the GO29781 study, which demonstrated pharmacokinetic non-inferiority of Lunsumio SC compared to its intravenous form. Lunsumio SC offers a significantly reduced administration time of approximately one minute, enhancing patient convenience and lifestyle flexibility. It provides a fixed-duration treatment option that can be initiated in an outpatient setting. The drug has shown a favorable benefit-risk profile with high rates of deep and durable remissions in third-line or later follicular lymphoma. Long-term data for both IV and SC administration routes will be presented at the upcoming ASH Annual Meeting. Phase III studies, including one investigating Lunsumio SC in combination with lenalidomide, are ongoing. Lunsumio is part of Roche's bispecific antibody portfolio, aimed at improving patient experience and offering treatment choices. Follicular lymphoma is the most common indolent form of non-Hodgkin lymphoma, often characterized by relapse. Lunsumio's mechanism involves T-cell engagement to eliminate B cells.
https://www.roche.com/media/releases/med-cor-2025-11-19 roche.com
RSS Hunter RSS Hunter • Nov 19, 2025

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s giredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer

Roche announced positive phase III results for investigational giredestrant in early-stage breast cancer. The lidERA study met its primary endpoint, showing a significant improvement in invasive disease-free survival. This marks the first phase III trial of a selective estrogen receptor degrader (SERD) to show benefit in the adjuvant setting. Giredestrant demonstrated a statistically significant and clinically meaningful benefit compared to standard-of-care endocrine monotherapy. These findings support its potential as a new standard of care for early-stage ER-positive breast cancer. Overall survival data showed a positive trend, and giredestrant was well-tolerated. Data will be presented at an upcoming medical meeting and submitted to health authorities. This is the second positive phase III result for giredestrant, following the evERA study. The extensive clinical program for giredestrant reflects Roche's commitment to improving outcomes for ER-positive breast cancer patients.
https://www.roche.com/media/releases/med-cor-2025-11-18 roche.com
RSS Hunter RSS Hunter • Nov 18, 2025

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s fenebrutinib shows unprecedented positive Phase III results as the potential first and only BTK inhibitor in both relapsing and primary progressive multiple sclerosis

Roche announced positive Phase III results for fenebrutinib. The investigational drug met its primary endpoint in the FENhance 2 study for relapsing multiple sclerosis (RMS), significantly reducing relapses compared to teriflunomide. In the FENtrepid study for primary progressive multiple sclerosis (PPMS), fenebrutinib demonstrated non-inferiority to OCREVUS in slowing disability progression. These results suggest fenebrutinib could be a highly effective oral treatment for both RMS and PPMS. Fenebrutinib targets B cells and microglia, aiming to reduce inflammation and chronic damage. Liver safety noted in studies is consistent with previous findings. The readout of the second RMS study, FENhance 1, is expected in the first half of 2026. All data will then be submitted for regulatory review. Fenebrutinib's dual mechanism of action offers potential for comprehensive multiple sclerosis care.
https://www.roche.com/media/releases/med-cor-2025-11-10 roche.com
RSS Hunter RSS Hunter • Nov 10, 2025