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.
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.
Genentech (OTCQX: RHHBY) launched a Direct-to-Patient program for Xofluza on October 16, 2025 to expand access and affordability for the upcoming flu season.
Key features: a $50 cash-pay option (stated as 70% lower than list price) available via Alto Pharmacy and Mark Cuban Cost Plus Drug Company; same-day home delivery in select U.S. markets through Alto Pharmacy and Amazon Pharmacy; nationwide mail delivery via all three partner pharmacies; and an enhanced manufacturer coupon letting eligible patients pay as little as $35 with up to $70 off.
Xofluza is described as a single-dose oral antiviral for patients age 5 and up and for post-exposure prophylaxis. The release cites CDC estimates for the 2024-25 season: 47–82 million illnesses, 21–37 million medical visits, 610,000–1.3 million hospitalizations, and 27,000–130,000 deaths.
Roche (OTCQX:RHHBY) presented advances in its sequencing by expansion (SBX) technology at ASHG 2025, highlighting improvements across bulk RNA sequencing, methylation mapping, spatial analyses, and target enrichment.
Key developments include a GUINNESS WORLD RECORD™ by Broad Clinical Labs for fastest DNA sequencing (sample-to-VCF under four hours) achieved with Roche Sequencing Solutions and Boston Children’s Hospital, a new multi‑project evaluation with the Wellcome Sanger Institute, SBX‑Duplex combined with TAPS for methylation mapping, spatial sequencing at the University of Tokyo (≈15 billion reads in one hour), and a UMI‑based SBX‑Simplex target enrichment workflow.
Roche (ROG) announced on October 13, 2025 that the FDA cleared its Elecsys pTau181 blood test as the only blood-based biomarker test indicated for use in primary care to help rule out Alzheimer's-related amyloid pathology. The test is for patients aged 55 and older, was developed with Eli Lilly, and showed a 97.9% negative predictive value in a multicenter study of 312 participants reflective of a primary-care population. With > 4,500 Roche instruments already in U.S. labs and recent CE Mark/IVDR certification, Roche says the test can broaden access, improve referrals, and reduce more invasive confirmatory testing such as PET and CSF.
Genentech (OTCQX: RHHBY) will present more than 30 abstracts across 10+ tumor types at ESMO Congress 2025 (October 17–21, 2025, Berlin).
Key clinical highlights include evERA (giredestrant) Phase III primary results meeting both co-primary endpoints with statistically significant progression-free survival (PFS) benefit in the ITT and ESR1-mutated populations; IMvigor011 (Tecentriq) ctDNA-guided Phase III topline showing statistically significant improvements in disease-free survival (DFS) and overall survival (OS); final OS from the pivotal ALEX (alectinib) study; and ~4-year adjuvant DFS follow-up from ALINA. Safety and important prescribing information for Itovebi (inavolisib) and Alecensa are included.
Roche (OTCQX: RHHBY) will present more than 30 abstracts across 10+ tumour types at ESMO Congress 2025 (17–21 October 2025) in Berlin.
Key highlights: evERA (giredestrant) met both co-primary endpoints with statistically significant, clinically meaningful progression-free survival benefits (late-breaking oral, 18 Oct 2025); IMvigor011 (Tecentriq) showed ctDNA-guided adjuvant treatment improved disease-free survival and overall survival (Presidential Symposium, 20 Oct 2025); ALEX (Alecensa) final overall survival results and ALINA (~4-year median follow-up) adjuvant DFS updates will be presented (17–20 Oct 2025).
Roche (OTCQX: RHHBY) announced on 6 October 2025 that it has received a CE mark for the Kidney Klinrisk Algorithm, described in the PR as the first AI‑based risk stratification tool for progressive kidney function decline. According to the PR, Roche is launching a Chronic Kidney Disease (CKD) algorithm panel on its navify® Algorithm Suite that pairs the new Kidney Klinrisk Algorithm (early risk assessment) with the established CE‑marked Kidney KFRE Algorithm (later stage management).
The PR states the panel combines routine blood and urine inputs, aligns recommendations with clinical guidelines, is cloud‑based and integrates with hospital systems, and will be available in Europe and the UK at launch with later rollouts planned for the United States, Middle East, and Asia.
Roche (OTCQX: RHHBY) announced FDA approval on October 3, 2025 of Tecentriq (atezolizumab) plus lurbinectedin (Zepzelca) as the first‑line maintenance regimen for adults with extensive‑stage small cell lung cancer (ES‑SCLC) whose disease has not progressed after induction with Tecentriq (or Tecentriq Hybreza), carboplatin and etoposide.
The approval is based on phase III IMforte: the combination reduced risk of progression or death by 46% and risk of death by 27%. Median overall survival was 13.2 vs 10.6 months (HR=0.73; p=0.0174); median PFS was 5.4 vs 2.1 months (HR=0.54; p<0.0001). Safety matched known profiles. NCCN updated the regimen to category 2A preferred for maintenance after Tecentriq+CE.
Roche (OTCQX: RHHBY) announced on 3 October 2025 that Dr. Claudia Süssmuth Dyckerhoff will not stand for re-election to the Roche Board at the 2026 Annual General Meeting. She has served on Roche's Board since March 2016 and will be nominated for election to the board of another company in the healthcare industry. Chairman Severin Schwan thanked her for a decade of contributions, citing her knowledge of healthcare and international market dynamics, particularly in Asia.
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