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.
Genentech, part of Roche (RHHBY), and Breastcancer.org launched About Damn Time, a campaign addressing life after initial breast cancer treatment. It focuses on women with hormone receptor-positive, HER2-negative early breast cancer who face ongoing therapy and survivorship needs after surgery, chemotherapy or radiation.
Developed with patients and advocacy organizations, the campaign offers educational resources, patient stories and tools at AboutDamnTime.com. Genentech says the initiative aims to help women prepare for conversations with their care teams about long-term treatment, side effects and recurrence concerns.
Genentech, part of Roche (RHHBY), presented new VOYAGER results showing Vabysmo’s real-world treatment outcomes across three retinal conditions at EURETINA 2026.
The prospective, non-interventional study includes more than 5,000 patients. After 12 months, previously untreated eyes gained 4.6 vision-chart letters in wet age-related macular degeneration and 8.2 in diabetic macular edema. Previously treated eyes changed by -0.1 and +2.7 letters, respectively. After six months, untreated branch and central/hemi retinal vein occlusion eyes gained 10.0 and 16.6 letters; previously treated eyes gained 2.0 and 3.9. Retinal thickness and fluid presence decreased across cohorts. Wet AMD and DME patients received fewer injections in months 7–12 than months 1–6. Safety was generally consistent with Phase III studies, with no new safety signals.
Roche (RHHBY) presented new VOYAGER real-world data showing Vabysmo treatment outcomes across three retinal conditions at EURETINA 2026 in Vienna.
After 12 months, previously untreated eyes gained 4.6 vision-test letters in neovascular age-related macular degeneration and 8.2 in diabetic macular edema. Previously treated eyes recorded changes of -0.1 and +2.7 letters, respectively. Retinal thickness and fluid presence decreased in both groups. After six months, vision and retinal thickness improved in untreated and previously treated eyes with branch or central/hemi-retinal vein occlusion.
Patients in the first two disease groups received fewer injections during months 7–12 than months 1–6. Across cohorts, no new safety signals emerged, and the safety profile was generally consistent with Phase III studies.
Roche (RHHBY) announced publication of phase III evERA results showing giredestrant plus everolimus improved progression-free survival in advanced breast cancer.
The study involved ER-positive, HER2-negative disease previously treated with a CDK4/6 inhibitor and endocrine therapy. Progression-free survival, the time before disease progression or death, was 8.8 versus 5.5 months in all randomised patients and 10.0 versus 5.5 months in patients with ESR1 mutations, compared with standard endocrine therapy plus everolimus. Risk reductions were 44% and 62%, respectively. Overall survival data remained immature; no unexpected safety findings occurred.
The FDA accepted applications for the combination in ESR1-mutated advanced disease and for giredestrant in early-stage disease, the latter under Priority Review. FDA goal dates are 18 December 2026 and 30 November 2026, respectively.
Roche (RHHBY) received FDA filing acceptance under priority review for fenebrutinib to treat relapsing and primary progressive multiple sclerosis. The application is supported by three Phase III trials. In FENhance 1 and 2, fenebrutinib reduced annualised relapse rates by 51% and 58%, respectively, versus teriflunomide over 96 weeks. Both studies also showed fewer active and chronic brain lesions and positive trends in delaying disability.
In FENtrepid, fenebrutinib met its primary endpoint of non-inferiority to Ocrevus, meaning it met the trial's criterion for comparable effectiveness in reducing disability progression. The numerical risk reduction was 12%, with a hazard ratio of 0.88 and 95% confidence interval of 0.75–1.03. Safety findings included more frequent liver enzyme elevations versus Ocrevus and an imbalance in reported fatalities across the three trials.
Roche (RHHBY) has launched a newborn screening test through its Diagnostics subsidiary TIB MOLBIOL in countries accepting the CE mark.
The LightMix Newborn TREC/SMN1/HBB kit simultaneously screens for spinal muscular atrophy (SMA), severe combined immunodeficiency (SCID) and sickle cell disease (SCD). The test is approved under the In Vitro Diagnostic Regulation (IVDR) and is intended for private and academic hospital laboratories. It runs on established LightCycler systems. Roche describes the screening as a first step toward immediate follow-up testing and treatment, helping clinicians identify these conditions before symptoms appear.
Roche (RHHBY) subsidiary Genentech broke ground on a $750 million expansion of its Hillsboro, Oregon, manufacturing facility.
Construction has started on a 211,000-square-foot addition that will double the existing site's size. Commercial operations are planned to begin in 2031. Once operational, the facility will add device fill-finish capacity, including combination products. It is designed for high- and low-volume filling of medicines across oncology, neurology and immunology.
The project is expected to create approximately 250 manufacturing jobs and support approximately 200 construction jobs. It advances capacity plans announced in August.
Roche (RHHBY) reported positive prespecified interim phase III IMAgINATION data for investigational sefaxersen in adults with primary IgA nephropathy.
The trial met its primary endpoint, with sefaxersen achieving statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks, measured by 24‑hour urine protein‑to‑creatinine ratio. The safety and tolerability profile was consistent with earlier studies, with no new safety signals observed. The once‑monthly subcutaneous therapy is designed for self‑administration. The 459‑patient study will remain blinded to assess change in kidney function over two years via estimated glomerular filtration rate at week 105, and interim results will be shared with regulators and at a medical congress.
Roche (RHHBY) plans a change in its Board of Directors by proposing Dr. Christophe Weber, former CEO of Takeda Pharmaceuticals, for election at the Annual General Meeting on 9 March 2027.
Chairman Severin Schwan said the company expects Weber’s healthcare expertise and leadership experience to further strengthen the Board. The release also reiterates Roche’s global healthcare focus across diagnostics and pharmaceuticals, including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology.
Genentech (RHHBY) reported positive prespecified interim Phase III IMAgINATION data for investigational sefaxersen in adults with primary IgA nephropathy (IgAN), where the trial met its primary endpoint of proteinuria reduction versus placebo at 37 weeks.
Sefaxersen achieved statistically significant and clinically meaningful decreases in proteinuria, measured by 24-hour urine protein-to-creatinine ratio, a surrogate marker strongly associated with long-term kidney function. The once-monthly subcutaneous therapy is designed for self-administration. The safety and tolerability profile was consistent with earlier data, with no new safety signals. The blinded study will continue to assess kidney function over two years, using estimated glomerular filtration rate at week 105, and interim data will be shared at a medical congress and with health authorities.