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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 (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.
Genentech (OTCQX:RHHBY) reported that the U.S. FDA granted priority review to its supplemental Biologics License Application for Gazyva (obinutuzumab) in adults with primary membranous nephropathy (pMN). The decision is based on Phase III MAJESTY results showing Gazyva’s superiority to tacrolimus, with 36.9% of adults achieving complete remission at two years versus 5.7% on tacrolimus (adjusted difference 31.1%; 95% CI 18.2–44.0; p<0.001).
The FDA, which previously granted Breakthrough Therapy Designation in pMN, is expected to decide on approval by November 2026. If approved, Gazyva would become the first FDA‑approved therapy for pMN. According to Genentech, safety in MAJESTY was consistent with Gazyva’s known profile, with no new safety signals identified. Gazyva already has U.S. and EU approvals for active lupus nephritis and has generated positive Phase III data across several immune‑mediated diseases.
Roche (OTCQX:RHHBY) announced the introduction of the cobas HDV test for use on its fully automated cobas 5800/6800/8800 systems in countries that accept the CE mark. The assay detects and quantifies Hepatitis D Virus (HDV) RNA, enabling clinicians to both diagnose infections and monitor treatment response.
According to Roche, this is the first high-throughput, fully automated HDV assay available, addressing reliance on manual and lab-developed tests. The launch supports care for an estimated 12 million people globally affected by HDV and aligns with the rollout of new HDV-specific treatments.
Roche (OTCQX:RHHBY) received CE Mark for its Elecsys IGRA TB blood test, enabling automated identification of tuberculosis infection on cobas immunoassay systems. The assay provides results in under 24 hours, processes each patient in about 19 minutes, and is designed for scalable, high-throughput laboratory workflows.
According to Roche, Elecsys IGRA TB showed 91.12% positive percent agreement, 94.57% negative percent agreement, 100% relative sensitivity in bacteriologically confirmed TB patients, and 95.32% specificity in a low-risk cohort when compared with established standard-of-care methods.