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/ADR (RHHBY) is linked to a stream of news that reflects the company’s activities in biotechnology, pharmaceuticals and diagnostics. Recent announcements from Roche and its U.S. affiliate Genentech highlight regulatory approvals, late‑stage clinical trial results, new diagnostic platforms and agreements related to access and manufacturing.
Investors and healthcare observers following RHHBY news will see updates on oncology and haematology programmes, such as the U.S. Food and Drug Administration’s accelerated approval of Lunsumio VELO, a subcutaneous CD20xCD3 bispecific antibody for relapsed or refractory follicular lymphoma after at least two prior lines of systemic therapy. News also covers Phase III data for the investigational oral SERD giredestrant in ER‑positive early‑stage breast cancer, as well as new data on Lunsumio combinations and long‑term outcomes in lymphomas presented at major scientific meetings.
On the diagnostics side, Roche has reported the U.S. launch of next‑generation cobas 6800/8800 systems and software upgrades, CE Mark approval for its cobas Mass Spec solution reagent pack for antibiotics drug monitoring, and CE Mark for the cobas BV/CV assay for bacterial vaginosis and candida vaginitis. These stories illustrate how the company is expanding its in‑vitro diagnostic menu and enhancing laboratory efficiency.
Additional news items include European Commission approval of Gazyva/Gazyvaro for lupus nephritis and Genentech’s agreement with the U.S. government addressing prescription drug costs and direct‑to‑patient programmes. For users of this page, the RHHBY news feed offers a central place to review such regulatory milestones, clinical trial readouts, product launches and policy‑related developments associated with Roche and the Roche Group.
Roche (OTCQX: RHHBY) announced that its subsidiary accepted for payment all shares validly tendered in its tender offer to acquire 89bio (NASDAQ: ETNB) at $14.50 per share in cash plus a non-tradeable contingent value right (CVR) for up to $6.00 per share. The tender offer expired at one minute after 11:59 p.m. New York time on October 29, 2025, and approximately 94,113,710 shares were validly tendered, representing about 60.49% of outstanding 89bio shares (excluding guaranteed-delivery certificates). Roche intends to complete a merger today to acquire the remaining shares, after which 89bio will become a wholly owned Roche subsidiary and its shares will cease trading on the Nasdaq Global Market.
Roche (OTCQX:RHHBY) received CE mark on 29 October 2025 for the Elecsys Dengue Ag test, a fully automated, high-throughput immunoassay to aid diagnosis of acute dengue infection. The test reports results in 18 minutes, claims high clinical sensitivity and specificity, and is inclusive for all four dengue virus serotypes. Automation aims to improve lab efficiency, traceability and reduce human error, supporting faster workflows and patient management during outbreaks. The announcement cites rising global dengue burden, with a 2024 peak of over 14.6 million cases and >12,000 deaths.
Genentech (OTCQX: RHHBY) reported positive Phase III INShore results for Gazyva (obinutuzumab) in children and young adults (ages 2–25) with idiopathic nephrotic syndrome on Oct 28, 2025. The study met its primary endpoint: more participants achieved sustained complete remission at week 52 versus mycophenolate mofetil (MMF).
Key secondary endpoints met included higher relapse-free survival, longer median time to relapse or death, reduced cumulative corticosteroid dose to week 52, and fewer relapses through week 52. No new safety signals were identified; safety aligned with the known adult profile. Data will be presented at a medical meeting and submitted to regulators including the FDA and EMA.
Roche (OTCQX: RHHBY) reported positive phase III INShore results for Gazyva/Gazyvaro (obinutuzumab) in children and young adults (aged 2–25) with idiopathic nephrotic syndrome.
The study met its primary endpoint: more participants achieved sustained complete remission at week 52 versus mycophenolate mofetil (MMF). Key secondary endpoints met included improved relapse-free survival, longer median time to relapse or death, reduced cumulative corticosteroid dose to week 52, and fewer relapses versus MMF. No new safety signals were identified. Data will be presented at a medical meeting and shared with FDA and EMA.
Roche (OTCQX: RHHBY) announced that Nina Schwab-Hautzinger (born 1975) will be appointed Head of Group Communications and join the enlarged Corporate Executive Committee effective 1 February 2026.
Schwab-Hautzinger rejoins Roche from BASF where she was Head of Corporate Communications and Government Relations. She previously spent 13 years at Roche in senior communications roles and has led a healthcare practice at a strategic communications consultancy in Singapore. Her academic background includes studies at University of Mannheim, University of Waterloo, and a doctorate from University of Zurich.
CEO Thomas Schinecker thanked the outgoing Head of Group Communications, Barbara Schaedler, who will remain to ensure a smooth hand-over.
Roche (OTCQX: RHHBY) reported Group sales of CHF 45.9bn for January–September 2025, a 7% increase at constant exchange rates (CER) and 2% in CHF, driven by Pharmaceuticals (+9% CER) and Diagnostics (+1% CER). The top five pharmaceutical drivers—Phesgo, Xolair, Hemlibra, Vabysmo and Ocrevus—generated CHF 15.8bn, up CHF 2.4bn at CER versus 2024. Roche raised its 2025 earnings outlook, targeting mid-single-digit Group sales growth (CER), high-single to low-double-digit core EPS growth (CER), and a higher Swiss-franc dividend.
Key developments include multiple regulatory approvals and positive phase III readouts, a merger agreement to acquire 89bio (FGF21 candidate for MASH), and next-generation sequencing tech decoding a genome in under four hours.
Roche (OTCQX: RHHBY) reported positive phase III IMvigor011 results for Tecentriq (atezolizumab) as adjuvant therapy in muscle-invasive bladder cancer using a ctDNA-guided approach.
At median follow-up 16.1 months, Tecentriq reduced risk of death by 41% (OS HR=0.59; 95% CI 0.39–0.90; median OS 32.8 vs 21.1 months) and risk of recurrence or death by 36% (DFS HR=0.64; 95% CI 0.47–0.87; median DFS 9.9 vs 4.8 months) versus placebo. The trial used Signatera ctDNA MRD testing to select patients and reported a safety profile consistent with prior studies. Results presented at ESMO Congress 2025 and will be discussed with health authorities including the FDA.
Genentech (OTCQX: RHHBY) reported positive Phase III IMvigor011 results showing that adjuvant Tecentriq (atezolizumab) given in a ctDNA-guided setting reduced risk of death by 41% and risk of disease recurrence or death by 36% versus placebo in muscle-invasive bladder cancer (MIBC).
At median follow-up of 16.1 months, median disease-free survival was 9.9 months with Tecentriq vs 4.8 months with placebo (HR=0.64; 95% CI 0.47–0.87; p=0.0047). Median overall survival was 32.8 months vs 21.1 months (HR=0.59; 95% CI 0.39–0.90; p=0.0131). The trial used Natera Signatera ctDNA testing to identify patients with molecular residual disease and spared ctDNA-negative people from adjuvant therapy.
Roche (OTCQX: RHHBY) announced FDA approval of Gazyva/Gazyvaro (obinutuzumab) on 20 October 2025 for adult patients with active lupus nephritis receiving standard therapy.
The approval followed phase II NOBILITY and phase III REGENCY data showing a higher complete renal response: 46.4% vs 33.1% with Gazyva/Gazyvaro plus standard therapy. The label permits four initial doses in year one, then dosing twice yearly, and a shorter 90-minute infusion option after the first infusion for eligible patients.
Genentech (RHHBY) announced FDA approval of Gazyva (obinutuzumab) on October 20, 2025 for adult patients with active lupus nephritis receiving standard therapy.
Approval was supported by Phase II NOBILITY and Phase III REGENCY, where 46.4% of patients on Gazyva plus standard therapy achieved complete renal response versus 33.1% on standard therapy alone. Gazyva showed reductions in proteinuria, anti-dsDNA, corticosteroid use, and complementary improvements in biomarkers. The label allows a shortened 90-minute infusion after the first dose for eligible patients and a dosing schedule of four initial doses in year one followed by twice-yearly maintenance.
Gazyva received Breakthrough Therapy designation in 2019 and has a recent CHMP positive opinion in Europe, with further regulatory decisions pending.