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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 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.
Genentech (RHHBY) has received U.S. FDA Priority Review for a supplemental Biologics License Application for Enspryng (satralizumab) to treat myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), a rare CNS autoimmune disease with no approved treatments. The FDA is expected to decide on approval by January 10, 2027.
The review is based on the Phase III METEOROID study, where Enspryng reduced the risk of MOGAD relapses by 68% versus placebo (p=0.0025), with 48‑week relapse‑free rates of 87% on Enspryng versus 67% on placebo, and improvements in annualized relapse rate, MRI lesion activity and rescue therapy use. The safety profile was consistent with more than a decade of Enspryng experience in neuromyelitis optica spectrum disorder. The European Medicines Agency has validated the MOGAD application, with a European Commission decision expected in Q3 2027.
Roche (RHHBY) received U.S. FDA Priority Review for a supplemental Biologics License Application for Enspryng (satralizumab) to treat myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The FDA decision on this filing is expected by 10 January 2027. If approved, Enspryng would become the first and only disease-modifying therapy for MOGAD, a rare autoimmune central nervous system disorder with no approved treatments.
The filing is supported by the Phase III METEOROID trial, in which Enspryng reduced the risk of MOGAD relapses by 68% versus placebo (p=0.0025), with 87% of treated patients relapse-free at 48 weeks compared with 67% on placebo, and showed benefits on annualised relapse rate, MRI lesion activity and rescue therapy use. The safety profile was consistent with over a decade of experience in neuromyelitis optica spectrum disorder. The EMA has also validated an application for Enspryng in MOGAD, with a European Commission decision expected in the third quarter of 2027.
Roche (OTCQX: RHHBY) reported new two-year Phase IIIb/IV SALWEEN data for Vabysmo (faricimab) in Asian patients with polypoidal choroidal vasculopathy (PCV), a severe subtype of neovascular age-related macular degeneration (nAMD). Patients gained an average of 7.3 letters in best-corrected visual acuity and showed a 127 µm reduction in central subfield thickness over weeks 100–108. At year two, 74% had no retinal fluid, 62% showed complete regression and 86% inactivation of polypoidal lesions. By the end of year two, 61% of patients were on an extended 20-week dosing interval. According to Roche, Vabysmo was well tolerated with a safety profile consistent with prior nAMD data.
Roche (OTCQX:RHHBY) announced that the US FDA has approved expanded use of its PATHWAY HER2 (4B5) immunohistochemistry test and VENTANA HER2 Dual ISH DNA Probe Cocktail as companion diagnostics for metastatic gastroesophageal adenocarcinoma (GEA), including gastric, gastroesophageal junction and esophageal adenocarcinoma.
The tests are now approved to assess HER2-positive status in adults with unresectable locally advanced or metastatic HER2‑positive GEA who may be eligible for two FDA‑approved first‑line ZIIHERA (zanidatamab‑hrii) regimens from Jazz Pharmaceuticals. According to Roche, this marks the first FDA approval of tests to determine HER2 status in esophageal cancer and broadens access to HER2‑targeted therapies. The assays, already widely used in breast and gastric cancers, are integrated into the VENTANA BenchMark platform and show high concordance with HER2 FISH testing, supporting more consistent, automated and precise HER2 assessment across multiple cancer types.