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) 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.
Roche (OTCQX:RHHBY) received U.S. FDA clearance for its Elecsys pTau217 blood test, the first and only FDA-cleared, single‑biomarker assay to aid both rule‑in and rule‑out assessment of amyloid pathology associated with Alzheimer's disease in adults 55+ with cognitive decline.
The test, developed with Eli Lilly, categorizes results as positive, intermediate or negative and must be interpreted alongside other clinical information. It showed high agreement with amyloid PET imaging and is designed for broad deployment across more than 4,500 Roche cobas laboratory instruments in the U.S., enabling integration into existing workflows. Roche highlights this as a key milestone in its Alzheimer's diagnostics portfolio and broader strategy spanning biomarkers and investigational therapies.
Roche (OTCQX: RHHBY), via its US subsidiary Genentech, plans to invest approximately $750 million in a new device fill-finish manufacturing facility at its 75-acre Hillsboro, Oregon campus. The project will double the site’s size, add end-to-end device filling capabilities and expand capacity for Roche and Genentech’s future medicines.
The investment is expected to create 250 high-wage manufacturing jobs plus about 200 construction jobs, with commercial operations targeted for 2031. The flexible facility will produce advanced drug delivery devices such as pre-filled syringes and autoinjectors and follows the recent topping out of Genentech’s new manufacturing site in Holly Springs, North Carolina.
Genentech (OTCQX: RHHBY) plans to invest approximately $750 million to build a new device fill-finish manufacturing facility at its 75-acre Hillsboro, Oregon campus. The project is expected to double the size of the existing site and add end-to-end device filling capabilities to Genentech’s U.S. network.
The investment is projected to create 250 high-wage manufacturing jobs and about 200 construction jobs in Oregon, with commercial operations targeted for 2031. The flexible facility will support advanced drug delivery devices, including pre-filled syringes and autoinjectors, strengthening domestic manufacturing and supply chain resilience.