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) 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.
Genentech (RHHBY) reported positive topline Phase II results for enicepatide (CT-388), a once-weekly dual GLP-1/GIP receptor agonist in adults with type 2 diabetes and overweight or obesity at 48 weeks.
At the highest titrated 24 mg dose, enicepatide reduced mean HbA1c by 2.65% from a baseline of 8.1%. In patients with poor baseline control (HbA1c >8.5%), HbA1c fell by 4.13%. By week 48, 90% of patients on 24 mg reached ≤6.5% HbA1c and 62% achieved normoglycemia (<5.7%). Mean weight loss in the 24 mg arm was 15.5% with no clear plateau. Safety and tolerability were consistent with established incretin therapies; adverse events were mainly mild-to-moderate gastrointestinal, and discontinuations due to adverse events were 2.0% for enicepatide versus 0.0% for placebo.
Genentech is conducting two Phase III chronic weight management trials and plans Phase III glycemic-control and cardiovascular outcomes programs from 2027.
Roche (RHHBY) reported positive 48‑week Phase II results for dual GLP‑1/GIP agonist enicepatide in adults with type 2 diabetes and overweight or obesity on 22 September 2026.
In the CT-388-104 trial, once-weekly enicepatide met both primary endpoints, showing dose-dependent reductions in HbA1c and body weight versus baseline. At the highest 24 mg dose, mean HbA1c fell by 2.65 percentage points from a baseline of 8.1%. In participants with poor baseline control (HbA1c >8.5%), the 24 mg dose produced a 4.13 percentage point HbA1c reduction.
By week 48, 90% of patients on 24 mg reached ≤6.5% HbA1c and 62% achieved normoglycemia (<5.7%). Mean weight loss at 48 weeks on 24 mg was 15.5% without a demonstrable plateau. Safety and tolerability were consistent with established incretin therapies, with mainly mild-to-moderate gastrointestinal events and a 2.0% discontinuation rate in enicepatide arms. Roche is running two Phase III studies in chronic weight management and plans a Phase III glycemic-control programme and cardiovascular outcomes trials in 2027.
Roche (RHHBY) received European Commission approval for Susvimo (ranibizumab 100 mg/mL solution for injection) on 21 September 2026 to treat neovascular age-related macular degeneration (nAMD) in adults over 60.
Susvimo is used with the Contivue Port Delivery Platform, a surgically implanted, refillable device that continuously delivers ranibizumab into the eye and can help maintain vision with as few as two treatments per year. Approval is based on the Phase III Archway trial and the Phase II Ladder and Portal studies, where Susvimo maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections, with long-term data showing vision maintenance for up to seven years and about 95% of patients needing no supplemental anti-VEGF therapy with two refills annually.