Roche Holding Ltd. (RHHBY) reports healthcare developments across medicines, diagnostics and digital health, including updates from Genentech as a member of the Roche Group. Recurring news covers operating and financial results, regional sales trends, product performance and regulatory disclosures tied to the company’s pharmaceutical and diagnostic portfolios.
Company updates frequently feature ophthalmology products and pipeline assets such as Vabysmo, Susvimo and vamikibart across retinal conditions including diabetic macular edema and neovascular age-related macular degeneration. Roche also reports clinical data in neurology and autoimmune disease, including fenebrutinib in multiple sclerosis and ENSPRYNG in myelin oligodendrocyte glycoprotein antibody-associated disease, along with diagnostics approvals and patient-education initiatives.
Roche (RHHBY) received FDA 510(k) clearance for its cobas eplex respiratory pathogen panel 3, expanding its cleared respiratory testing portfolio. The RP3 test detects up to 19 viral and bacterial targets from one nasopharyngeal swab sample. It adds Bordetella pertussis to the targets covered by the earlier RP2 panel and includes updated influenza virus and SARS-CoV-2 assays to improve coverage of current and recently circulating strains.
Laboratories can select up to five panel configurations to match local disease prevalence and patient needs, using cobas eplex system software version 3.0 or higher. The automated workflow requires less than one minute of hands-on preparation and delivers qualitative results in less than two hours. Unlike RP3, the earlier RP2 panel operates under an Emergency Use Authorization and has not been cleared or approved by the FDA.
Roche (RHHBY) has globally launched the VENTANA BAP1 (SP527) test to help distinguish mesothelioma from other cancers and benign tissue growth. The automated tissue-staining test is registered as a Class I in vitro diagnostic with the U.S. Food and Drug Administration and has received IVDR approval as a Class C device.
The test detects loss of BAP1 expression in cell nuclei and is used alongside markers that identify mesothelial tissue. Roche says BAP1, together with its recently launched MTAP and Claudin-4 tests, helps distinguish cancers while preserving limited patient tissue for molecular sequencing and other testing.
Roche (RHHBY) has received the CE Mark for its cobas smart e immunoanalyser, a standalone testing platform for smaller laboratories.
The system complements Roche’s cobas e 402 and cobas e 801 analytical units and uses the same reagents and Elecsys technology. Roche plans a menu of over 100 assays, launched in sequential waves. The platform occupies under one square metre, with reaction times of 18 minutes or less for more than 90% of Roche immunoassays. Roche says it enables smaller facilities to bring testing in-house and reduce diagnostic turnaround times.
Roche (RHHBY) reported that investigational divarasib improved survival versus sotorasib or adagrasib in previously treated KRAS G12C-mutated lung cancer.
The phase III Krascendo 1 trial enrolled 338 adults with advanced or metastatic non-small cell lung cancer and met its primary and key secondary endpoints. Divarasib reduced the risk of death by 44%; median overall survival was 17.7 months versus 12.0 months. The risk of disease progression or death fell 42%, with median progression-free survival of 9.8 versus 5.7 months. Confirmed tumour response rates were 58% versus 32%.
No new safety findings emerged. Treatment-related adverse events caused discontinuation in 4.8% versus 11.7% of participants. Common treatment-related effects included gastrointestinal toxicity and liver toxicity. Roche is advancing phase III studies across additional treatment settings. Results were presented at ESMO 2026 and published in The New England Journal of Medicine.
Roche (RHHBY) reported interim phase III results showing sefaxersen reduced proteinuria by 43.1% relative to placebo in adults with IgA nephropathy. The reduction in urine protein, an indicator of kidney damage, was measured at 37 weeks in patients receiving optimised standard care. The primary endpoint result was statistically significant (95% confidence interval: 32.5–52.0; P<0.0001), with consistent effects across all prespecified subgroups.
Among patients with blood in their urine at baseline, a greater proportion achieved resolution with sefaxersen than placebo at week 37. Treatment was well tolerated, with no new safety signals. The 459-person IMAgINATION study remains blinded and will assess kidney function at week 105. Roche plans to share data with health authorities. Sefaxersen remains investigational and is intended for once-monthly injection under the skin, with self-administration at home.
Genentech, part of Roche (RHHBY), presented interim Phase III results showing sefaxersen reduced proteinuria versus placebo in IgA nephropathy.
In IMAgINATION, adults receiving optimized standard care had a 43.1% reduction relative to placebo at 37 weeks in proteinuria, a marker of kidney damage, measured by 24-hour urine protein-to-creatinine ratio (95% confidence interval: 32.5–52.0; P<0.0001). Treatment effects were consistent across all prespecified subgroups. Among patients with blood in their urine at baseline, a greater proportion achieved resolution with sefaxersen than placebo at Week 37.
Sefaxersen was well tolerated, with no new safety signals and a safety profile consistent with Phase II. The blinded study continues to evaluate kidney-function change at week 105. Genentech plans to share the data with health authorities. The investigational treatment is designed for once-monthly injection under the skin at home.
Roche (RHHBY) reported third-quarter sales growth of 7% at constant exchange rates, alongside higher sales across both divisions in January–September. Third-quarter growth in Swiss francs was 8%. Nine-month Group sales reached CHF 46,493 million, up 6% at constant exchange rates (CER), which exclude currency movements, and 1% in Swiss francs. Pharmaceuticals sales rose 7% at CER to CHF 36,212 million; Diagnostics rose 4% to CHF 10,281 million, with reported Swiss-franc sales stable.
US approvals covered Enspryng for thyroid eye disease, Tecentriq for certain stage III colon cancer and Gazyva/Gazyvaro for a childhood-onset kidney condition. Pipeline updates included positive phase III results and FDA Priority Reviews for fenebrutinib and Enspryng. Roche confirmed its 2026 outlook: mid-single-digit sales growth and a high-single-digit core earnings-per-share target at CER, plus an expected dividend increase in Swiss francs.
Roche (RHHBY) presented Phase III neuroimmunology data, including a 55% reduction in annualised relapse rate with investigational fenebrutinib versus teriflunomide. Pooled relapsing multiple sclerosis trials measured that reduction over 96 weeks; annual brain volume loss fell 23% and 12-week confirmed disability progression on a composite measure fell 16%. Fenebrutinib also reduced slowly expanding lesion volume by up to 30% versus active comparators in relapsing and primary progressive disease.
With Ocrevus, 90% of children aged 10–17 at trial entry remained relapse-free over two years. European Commission approval for paediatric relapsing-remitting multiple sclerosis followed on 15 October. Exploratory Enspryng results in MOGAD, an autoimmune disease, showed numerically better recovery after relapse versus placebo. Roche expects a U.S. approval decision for MOGAD in January 2027.
Roche (RHHBY), through Genentech, presented Phase III neuroimmunology data showing benefits for fenebrutinib, Ocrevus and Enspryng across neurological diseases.
Pooled relapsing multiple sclerosis trials showed investigational fenebrutinib reduced annualized relapse rates by 55% versus the comparator over 96 weeks. It also reduced annual total brain volume loss by 23% and 12-week confirmed disability progression on a composite measure by 16%. Slowly expanding lesion volume fell by up to 30% versus active comparators in relapsing and primary progressive MS.
In OPERETTA 2, 90% of Ocrevus-treated children aged 10–17 at entry remained relapse-free over two years. Exploratory METEOROID analyses associated Enspryng with numerically better recovery after relapses in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The company expects a U.S. decision on Enspryng for MOGAD in January 2027.
Roche (RHHBY) will present phase III cancer results at ESMO 2026, including divarasib’s superiority over first-generation KRAS G12C inhibitors. The meeting runs from 23 to 27 October in Madrid. Krascendo 1 compared divarasib with sotorasib or adagrasib in previously treated advanced KRAS G12C-mutated non-small cell lung cancer.
Patient-reported outcomes from lidERA suggest giredestrant’s improved efficacy versus standard endocrine therapy in early-stage breast cancer did not compromise tolerability or health-related quality of life. Roche also highlighted potential efficacy and a favourable safety profile for Tam-Peli in phase III results in Chinese patients with metastatic nasopharyngeal carcinoma. It plans to initiate global Tam-Peli trials across multiple tumour types.