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), 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.
Roche (OTCQX:RHHBY) will showcase integrated diagnostic, digital and point-of-care solutions at the ADLM 2026 Annual Scientific Meeting & Clinical Lab Expo in Anaheim, July 28–30. At booth no. 2901, Roche will unveil the cobas® Mass Spec solution live and feature the new AXELIOS 1 next-generation sequencing platform* for genomics research.
The company will highlight automation for core and molecular labs, AI-enabled digital pathology, decentralized point-of-care platforms, and its FDA-cleared Elecsys® Phospho-Tau (181P) blood test, alongside the navify® Digital Solutions portfolio for lab operations, analytics, quality and POC management.
Roche (OTCQX:RHHBY) has appointed Dan Malarek, currently CEO of Foundation Medicine, as President and CEO of Roche Diagnostics North America, effective August 1, 2026. He will be based in Indianapolis and report to Matt Sause, Global CEO of Roche Diagnostics. Malarek succeeds Brad Moore, who will retire at the end of July after nearly 10 years with Roche.
Roche also created a new role, appointing Antonio Vergara as Chief Commercial Officer of Roche Diagnostics U.S., also effective August 1, 2026, reporting to Malarek. Concurrently, Foundation Medicine COO Vera Grossmann becomes interim CEO while a search for a permanent successor is conducted, according to Roche.
Roche (OTCQX:RHHBY) reported that the US FDA granted Priority Review to its supplemental Biologics License Application for Gazyva/Gazyvaro (obinutuzumab) in adults with primary membranous nephropathy (pMN). The review is supported by phase III MAJESTY data showing Gazyva/Gazyvaro was superior to tacrolimus.
MAJESTY met its primary endpoint: 36.9% of adults on Gazyva/Gazyvaro achieved complete remission at 104 weeks versus 5.7% with tacrolimus (adjusted difference 31.1%; 95% CI 18.2–44.0; p<0.001). Key secondary endpoints also favored Gazyva/Gazyvaro and safety was consistent with its known profile, with no new safety signals identified.
The FDA previously granted Breakthrough Therapy Designation for Gazyva/Gazyvaro in pMN and is expected to decide on approval by November 2026. If approved, it would be the first FDA-approved therapy for pMN. MAJESTY is the fourth positive phase III study of Gazyva/Gazyvaro in immune-mediated diseases, and data are being submitted to additional health authorities, including the EMA.