Welcome to our dedicated page for Roche Hldg news (Ticker: RHHBY), a resource for investors and traders seeking the latest updates and insights on Roche Hldg stock.
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 (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.
Genentech (OTCQX:RHHBY) marked a key construction milestone by placing the final beam on its new biomanufacturing facility in Holly Springs, North Carolina, completing the building’s structural framework. The company is investing approximately $2 billion in its first East Coast manufacturing site.
According to Genentech, the plant will produce next-generation treatments for metabolic conditions such as obesity and will use advanced biomanufacturing, automation, robotics, and an AI-powered digital twin to simulate operations and reduce waste. The project is expected to support more than 2,000 jobs, including over 500 high-wage manufacturing roles and 1,500 construction jobs, and forms part of Roche and Genentech’s broader $50 billion U.S. R&D and manufacturing commitment.
Roche (OTCQX: RHHBY) announced the launch of two new real-time PCR tests for research detection of Cyclospora cayetanensis, developed with subsidiary TIB MOLBIOL, to support U.S. public health efforts amid an ongoing cyclospora outbreak.
The LightMix® Modular Cyclospora assay (RUO) targets cyclospora only on LightCycler® 480 and LightCycler® PRO instruments, while the LightMix® OneTube Gastro Para 2 assay (RUO) enables multiplex detection of six gastrointestinal parasites, including Cyclospora. These tests complement the existing UC-TIB-Gastro-PARA-2 multiplex RUO assay for cobas® 5800/6800/8800 systems. All assays are for research use only and not for diagnostic procedures.
Roche (OTCQX:RHHBY) announced that the U.S. FDA has granted 510(k) clearance for the cobas® BV/CV assay, a real-time PCR test that detects organisms associated with bacterial vaginosis and Candida vaginitis from a single clinician-collected or clinician-instructed, self-collected vaginal swab.
The in vitro diagnostic assay, for professional laboratory use on the cobas® 6800/8800 systems, provides simultaneous BV and CV results for symptomatic women and can be combined with cobas® CT/NG and cobas® TV/MG assays for broader sexual-health testing from the same sample. According to Roche, this supports faster, more accurate diagnosis, streamlined workflows for laboratories and clinics, and integration with CDC guidelines on Candida speciation. Roche plans to extend the assay to the cobas® 5800 system under the FDA’s Reagent Replacement and Instrument Family Policy, with U.S. commercial launch expected later in 2026.
Roche (OTCQX: RHHBY) announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of Susvimo (ranibizumab injection) 100 mg/mL for treating neovascular age-related macular degeneration (nAMD). Susvimo is continuously released into the eye via the Contivue refillable implant.
The opinion is based on the Phase III Archway trial and the LADDER and Portal studies, which showed vision outcomes equivalent to monthly intravitreal ranibizumab and maintenance of vision for up to seven years. With two refills per year, about 95% of patients needed no additional anti-VEGF therapy. A final decision by the European Commission is pending.
Roche (OTCQX:RHHBY) reported first-half 2026 Group sales of CHF 30.4 billion, up 6% at constant exchange rates (CER), but -2% in CHF, with Pharmaceuticals +6% CER and Diagnostics +3% CER. Core operating profit rose 10% CER to CHF 11.9 billion and core EPS increased 9% CER, while IFRS operating profit declined 6% in CHF to CHF 9.7 billion due to Swiss franc appreciation.
Growth was driven by Xolair, Hemlibra, Ocrevus, Phesgo and Vabysmo, which together generated CHF 11.0 billion (+12% CER). According to Roche, it secured five US FDA Priority Reviews, reported positive phase III data for divarasib and fenebrutinib, launched the Axelios 1 sequencing platform, announced the PathAI acquisition and confirmed its 2026 outlook for mid single-digit sales and high single-digit core EPS growth (CER) with a further dividend increase in CHF.