Roche Hldg Stock Price, News & Analysis

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.