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) received the CE Mark for its cobas® BV/CV PCR assay on 9 December 2025 to detect bacteria causing bacterial vaginosis and yeast causing candida vaginitis from a single vaginal swab.
The test enables broader sexual health testing on cobas 5800/6800/8800 systems without an additional sample, aims to improve diagnostic accuracy versus microscopy/pH/clinical observation, and is now available in countries accepting the CE Mark.
Market context: the global sexual health segment is valued at CHF 1.1 bn with 11% annual growth; vaginitis growth is cited at 26% yearly.
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.