Roche Hldg Stock Price, News & Analysis

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.

Roche (OTCQX: RHHBY) on 18 October 2025 reported positive phase III evERA results showing giredestrant plus everolimus significantly improved progression-free survival (PFS) versus standard-of-care endocrine therapy plus everolimus in post-CDK4/6 inhibitor ER-positive, HER2-negative advanced breast cancer.

Key metrics: PFS risk reduction of 44% (ITT; HR=0.56; median 8.77 vs 5.49 months) and 62% (ESR1-mutated; HR=0.38; median 9.99 vs 5.45 months). OS data were immature but trended favorably; safety was manageable with no new signals, including no photopsia.

Roche (OTCQX: RHHBY) reported phase III data for investigational vamikibart in uveitic macular edema (UME) from two pivotal trials, MEERKAT and SANDCAT, presented 17 October 2025.

MEERKAT showed statistically significant superiority versus sham for the primary endpoint: ≥15-letter BCVA gain at week 16 (0.25 mg +19.9% P=0.0008; 1 mg +36.9%). SANDCAT did not meet nominal primary significance (0.25 mg +20.7% nominal; 1 mg +10.9% P=0.0699). Both trials showed rapid mean BCVA and central subfield thickness (CST) improvements versus sham. Vamikibart was generally well tolerated with low intraocular inflammation rates and no retinal occlusive vasculitis observed.

Genentech (OTCQX:RHHBY) announced Phase III pivotal data for vamikibart in uveitic macular edema (UME) from two trials, MEERKAT and SANDCAT, presented at AAO 2025. MEERKAT showed statistically significant superiority vs sham for the primary endpoint: proportion gaining ≥15 letters (0.25 mg: +19.9%, P=0.0008; 1 mg: +36.9%). SANDCAT had nominal/non‑significant primary results (0.25 mg: +20.7% nominal; 1 mg: +10.9%, P=0.0699). Both trials showed rapid, clinically meaningful improvements in BCVA and large reductions in central subfield thickness. Vamikibart was generally well tolerated with low rates of intraocular inflammation and no retinal occlusive vasculitis reported.

Roche (OTCQX:RHHBY) announced that the European Medicines Agency's CHMP has recommended approval of Gazyva/Gazyvaro (obinutuzumab) with mycophenolate mofetil for adults with active Class III or IV lupus nephritis, with or without Class V. A European Commission decision is pending.

Recommendation is based on phase II NOBILITY and phase III REGENCY data: 46.4% of patients on Gazyva plus standard therapy achieved complete renal response versus 33.1% on standard therapy alone, with a significant reduction in corticosteroid use and improved proteinuric response. Safety was consistent with known haematology-oncology profile. An FDA decision is expected later this year.