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 (RHHBY) announced that the European Commission approved Gazyva/Gazyvaro (obinutuzumab) on 9 December 2025 for adults with active Class III or IV, with or without Class V, lupus nephritis, in combination with mycophenolate mofetil (MMF).
The approval was based on phase II NOBILITY and phase III REGENCY results: 46.4% of patients on Gazyva plus standard therapy achieved complete renal response versus 33.1% on standard therapy alone. Data also showed reduced corticosteroid use and improved proteinuric response. The EC decision follows a U.S. FDA approval in October 2025. Roche said the treatment could benefit up to an estimated 135,000 people with lupus nephritis in the EU.
Roche (OTCQX: RHHBY) presented data at ASH 2025 showing Lunsumio (mosunetuzumab) combinations may be effective earlier in lymphoma care.
Key results: a 54-patient US CELESTIMO cohort of Lunsumio plus lenalidomide showed a CR 87.0% (95% CI: 75.1–94.6) with mostly low-grade CRS; Lunsumio plus Polivy in 2L+ LBCL gave ORR 77.5% vs 50.0% (comparator) and median PFS 25.4 vs 6.4 months. Long-term follow-up in R/R FL showed durable responses, including a 5-year OS 78.5% and sustained CR durations for IV and SC formulations.
Genentech (OTCQX:RHHBY) presented data on Lunsumio (mosunetuzumab-axgb) showing potential in earlier lymphoma treatment lines at ASH 2025. Key findings: CELESTIMO single-arm extension (n=54) reported a complete response 87.0% in 2L+ follicular lymphoma; cytokine release syndrome occurred in 27.8% (mostly Grade 1–2). SC Lunsumio + Polivy in 2L+ large B-cell lymphoma showed ORR 77.5% vs 50.0% comparator and median PFS 25.4 vs 6.4 months. Long-term follow-up in 3L+ FL reported 5-year overall survival 78.5% and durable CRs. No new safety signals reported; FDA decision in the U.S. expected soon.
Roche (RHHBY) reported three-year follow-up from the phase III STARGLO study in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) on 8 December 2025.
After a median follow-up of 35.1 months, overall survival was longer with Columvi (glofitamab) plus GemOx versus R-GemOx (25.5 vs 12.5 months; HR=0.60, 95% CI: 0.43-0.8). Median PFS was 20.4 vs 5.5 months (HR=0.41). In second-line patients median OS was not reached with the Columvi combo; 54.6% were alive at 36 months.
The combination is approved in more than 50 countries and included in major guidelines, but the FDA issued a Complete Response Letter for the US supplemental application. Cytokine release syndrome occurred in 44.8% of Columvi-treated patients.
Roche (OTCQX:RHHBY) announced U.S. FDA 510(k) clearance with a CLIA waiver and CE IVDR certification for its first point-of-care PCR test for Bordetella infections, including whooping cough, on 2 December 2025.
The cobas liat system delivers PCR-accurate results in 15 minutes at GP practices and emergency rooms, and detects and differentiates three Bordetella species (B. pertussis, B. parapertussis, B. holmesii) to support faster, targeted treatment and reduce severe complications and transmission.
Roche (OTCQX: RHHBY) announced the European Commission granted conditional marketing authorisation for Lunsumio (mosunetuzumab) subcutaneous for adult patients with relapsed or refractory follicular lymphoma after two or more systemic therapies (3L+ FL) on 19 November 2025.
Approval is based on the phase I/II GO29781 study showing pharmacokinetic non‑inferiority vs IV and no unexpected safety signals. Lunsumio SC offers an approximately one‑minute injection versus a 2–4 hour IV infusion. Long‑term IV data show 57% of patients in CR remained in remission at five years. Data will be presented at ASH and have been submitted to other regulators including the FDA; Phase III studies including MorningLyte are ongoing.
Genentech (RHHBY) announced positive Phase III lidERA results on November 18, 2025, where investigational oral giredestrant met the trial's primary endpoint at a pre-planned interim analysis.
The study showed a statistically significant and clinically meaningful improvement in invasive disease-free survival versus standard-of-care endocrine monotherapy in ER-positive, HER2-negative early-stage breast cancer. Overall survival was immature but showed a positive trend. Giredestrant was well tolerated with no unexpected safety findings. lidERA is described as the first Phase III SERD to show adjuvant benefit and follows a prior positive Phase III readout (evERA) presented at ESMO 2025.
Roche (OTCQX: RHHBY) reported positive Phase III results from the lidERA trial of investigational oral SERD giredestrant in ER-positive, HER2-negative early-stage breast cancer on 18 November 2025. At a pre-planned interim analysis the study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival versus standard-of-care endocrine monotherapy.
lidERA is described as the first Phase III SERD to show a benefit in the adjuvant setting and is the second positive Phase III readout for giredestrant after evERA. Overall survival was immature at interim but trended positively; safety was consistent with the known profile with no unexpected findings. Data will be presented at a medical meeting and shared with health authorities.
Roche (OTCQX: RHHBY) commissioned a Europe survey (5,518 respondents) and found 31% of eligible millennials (age 29–42) postponed or missed cervical screening—27% above the all-age average. The research reports fear (30%) and workplace demands as top barriers, with high-income earners 22% more likely to delay and 27% of parents reporting missed appointments. Millennials cited workplace flexibility (19%), travel/childcare support (12%), and encouragement (10%) as motivators. Roche promotes self-sampling and tailored outreach to increase attendance and advance its cervical cancer elimination campaign.
Genentech (OTCQX: RHHBY) reported that the first pivotal RMS Phase III (FENhance 2) met its primary endpoint, with investigational fenebrutinib significantly reducing annualized relapse rate versus teriflunomide over at least 96 weeks. In the pivotal PPMS study (FENtrepid), fenebrutinib was non-inferior to ocrelizumab for delaying composite confirmed disability progression over at least 120 weeks, with a numerical benefit seen from week 24 onward. Liver safety was reported as consistent with prior studies and additional safety data are under evaluation. The second RMS readout (FENhance 1) is expected in the first half of 2026 and together with the remaining data will inform regulatory submissions.