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) 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 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.
Roche (RHHBY) received a positive CHMP recommendation to approve Ocrevus for children and adolescents with relapsing multiple sclerosis.
The opinion covers paediatric patients aged 10 years and older with relapsing forms of MS, with a final decision by the European Commission expected in the near future. The recommendation is based on the Phase III OPERETTA 2 trial, where Ocrevus reduced relapse risk by 48% versus fingolimod and achieved greater suppression of brain inflammation, with new or enlarging T2 lesions reduced by 48% and gadolinium-enhancing T1 lesions reduced by 87%.
Safety in paediatric patients was consistent with the established Ocrevus profile in more than 525,000 treated adults, with no treatment discontinuations due to side effects.
Roche (RHHBY) has opened the Roche Genentech Innovation Center Boston as its new Cardiovascular, Renal and Metabolism hub within Harvard’s Enterprise Research Campus in Allston.
The center brings together discovery research, clinical development, artificial intelligence and data science to create an end-to-end R&D environment from early discovery through late-stage clinical development. It expands Roche and Genentech’s presence in the Greater Boston life sciences ecosystem and forms part of their stated USD 50 billion investment commitment in US manufacturing and R&D, which also includes recent facilities in North Carolina and Oregon.
Genentech (RHHBY), a member of the Roche Group, has opened the Roche Genentech Innovation Center Boston under a 10-year lease for a 95,000-square-foot facility with capacity for up to 500 people across research, clinical development and data science.
Located at Harvard’s Enterprise Research Campus in Allston, the center focuses on cardiovascular, renal and metabolic diseases and integrates artificial intelligence, machine learning and data science across discovery through late-stage clinical development. The site complements existing R&D hubs in South San Francisco and Basel and forms part of Roche and Genentech’s stated $50 billion commitment to U.S. manufacturing and R&D, which includes a network of 15 R&D centers and 13 manufacturing sites employing about 25,000 people nationwide.
Roche (RHHBY) reported that the phase III CELESTIMO trial of Lunsumio (mosunetuzumab) plus lenalidomide versus MabThera/Rituxan (rituximab) plus lenalidomide in relapsed or refractory follicular lymphoma after at least one prior line of therapy met its primary endpoint at interim analysis.
The Lunsumio-based regimen delivered a statistically significant and clinically meaningful improvement in progression-free survival. Overall survival data were immature at the time of analysis. The safety profile of Lunsumio plus lenalidomide was consistent with the known profiles of the individual medicines, with no new safety signals. CELESTIMO is a confirmatory study intended to convert Lunsumio’s accelerated/conditional approval in third-line or later follicular lymphoma to full approval and to support a second-line or later indication. Roche plans to submit the data to health authorities and present them at an upcoming medical meeting.
Genentech (RHHBY) reported that the Phase III CELESTIMO study of Lunsumio (mosunetuzumab-axgb) plus lenalidomide versus Rituxan (rituximab) plus lenalidomide in relapsed or refractory follicular lymphoma met its primary endpoint at interim analysis.
The Lunsumio-based regimen delivered a statistically significant and clinically meaningful improvement in progression-free survival in patients who had received at least one prior systemic therapy. Overall survival data were immature at the time of the interim analysis. The safety profile of Lunsumio plus lenalidomide was consistent with the known profiles of the individual medicines and no new safety signals were identified.
CELESTIMO serves as the confirmatory trial required to convert Lunsumio’s accelerated/conditional approval in third-line or later follicular lymphoma to full approval and to support a second-line or later indication. Genentech plans to submit the data to health authorities and present them at an upcoming medical meeting.
Roche (RHHBY) reported that collaborator MediLink’s phase III TAISHAN-302 trial in China met its primary endpoint, with Tam-Peli significantly improving overall survival versus topotecan in relapsed small-cell lung cancer.
Tam-Peli reduced the risk of death by 54%, with median OS of 13.3 vs 9.4 months (HR 0.46; p<0.0001), and cut the risk of disease progression by 71%, with median PFS of 7.4 vs 2.8 months (HR 0.29; p<0.0001). Confirmed objective response rates were 59.1% for Tam-Peli vs 9.7% for topotecan. Consistent OS and PFS benefits were seen across prespecified subgroups, including patients with brain metastases.
Grade ≥3 treatment-related adverse events were lower with Tam-Peli (46.4% vs 74.7%), although ILD/pneumonitis of any grade occurred in 4.9% vs 1.4% of patients. China’s CDE has accepted the Tam-Peli New Drug Application, and Roche plans rapid initiation of global phase III trials in its licensed territories.