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 FDA acceptance of the New Drug Application for giredestrant plus everolimus to treat ER-positive, HER2-negative, ESR1-mutated advanced breast cancer. The filing is supported by Phase III evERA results showing PFS benefit and a PDUFA date of December 18, 2026.
evERA reported PFS hazard ratios of 0.56 (ITT) and 0.38 (ESR1-mutated), with median PFS 8.77 and 9.99 months respectively; OS data remain immature but show positive trends.
Roche (OTCQX: RHHBY) announced FDA acceptance of its New Drug Application for giredestrant plus everolimus to treat adult patients with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer. The FDA set a PDUFA date of 18 December 2026.
Phase III evERA data showed PFS risk reductions of 44% (ITT) and 62% (ESR1-mutated), with median PFS 8.77 months (ITT) and 9.99 months (ESR1-mutated) versus ~5.5 months for comparators; OS data remain immature with positive trends.
Roche (OTCQX: RHHBY) announced Mark Dawson, M.D., Ph.D., will become Head of Roche Pharma Research and Early Development (pRED) and join the Enlarged Corporate Executive Committee, effective 1 May 2026.
Dawson joins from Peter MacCallum Cancer Centre, brings clinical and epigenetics expertise, multiple international honors, and academic appointments that position him to lead Roche pRED's next-generation therapy efforts.
Roche (OTCQX:RHHBY) announced that the phase III MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, with significantly more patients achieving complete remission at 104 weeks with Gazyva/Gazyvaro versus tacrolimus.
Key secondary endpoints (overall remission at week 104 and complete remission at week 76) were also statistically significant. Safety was consistent with the known profile and no new safety signals were identified. Data will be presented at a medical meeting and shared with US and EU health authorities.
Genentech (NYSE:RHHBY) announced that the Phase III MAJESTY study in primary membranous nephropathy met its primary endpoint, with significantly more patients achieving complete remission at two years (104 weeks) with Gazyva versus tacrolimus. Safety was consistent with Gazyva's known profile and no new safety signals were identified.
Key secondary endpoints showed significant benefits in overall remission at week 104 and complete remission at week 76. Data will be shared with regulators and at a medical meeting.
Roche (OTCQX: RHHBY) reported Phase III FENtrepid results showing investigational oral BTK inhibitor fenebrutinib met the primary non-inferiority endpoint versus OCREVUS in primary progressive MS (PPMS).
Fenebrutinib reduced risk of 12-week confirmed disability progression by 12% (HR 0.88; 95% CI 0.75–1.03), showed a 26% benefit on upper limb function (9HPT), and plans regulatory submissions after the FENhance 1 readout expected mid‑first half 2026.
Roche (OTCQX: RHHBY) reported 2025 Group sales of CHF 61.5 billion, up 7% at constant exchange rates (2% in CHF). Core operating profit rose 13% to CHF 21.8 billion and core EPS increased 11% to CHF 19.46. IFRS net income was CHF 13.8 billion (+58% IFRS).
Key milestones: US and EU approval of subcutaneous Lunsumio, EU approval of Gazyva/Gazyvaro for lupus nephritis, multiple positive late‑stage trial readouts, 10 molecules advanced to phase III, CE marks for new diagnostic tests, and a proposed dividend of CHF 9.80 per share.
Genentech (OTCQX: RHHBY) reported positive Phase II topline results for CT-388, a once-weekly dual GLP-1/GIP receptor agonist for obesity. At the 24 mg dose, CT-388 produced a placebo-adjusted weight loss of 22.5% (efficacy estimand) and 18.3% (treatment‑regimen estimand) at 48 weeks, with a clear dose-response and no weight‑loss plateau. Responder rates at 48 weeks for 24 mg included 95.7% ≥5%, 87% ≥10%, 47.8% ≥20%, and 26.1% ≥30%. Among pre-diabetic participants, 73% normalized glucose vs 7.5% placebo. Safety was consistent with the incretin class; discontinuations for adverse events were 5.9% in CT-388 arms vs 1.3% placebo. Phase III (Enith1/Enith2) is expected to start this quarter.
Roche (OTCQX: RHHBY) reported positive Phase II topline results for CT-388, a once-weekly dual GLP-1/GIP agonist for obesity. At the highest tested dose (24 mg) CT-388 achieved a placebo-adjusted weight loss of 22.5% (efficacy estimand) and 18.3% (treatment-regimen estimand) at 48 weeks, with a clear dose-response and no weight-loss plateau. At 24 mg, 95.7% lost ≥5%, 87% lost ≥10%, 47.8% lost ≥20%, and 26.1% lost ≥30% at week 48. 73% of pre-diabetic participants normalized blood glucose versus 7.5% for placebo. Safety was consistent with the incretin class; discontinuations for AEs were 6%. Phase III programme (Enith1/Enith2) is expected to start this quarter.
Genentech (OTCQX: RHHBY) will more than double its initial investment in a new Holly Springs, North Carolina biomanufacturing facility to approximately $2 billion, expanding the project announced in May 2025 and begun in August 2025. The expanded buildout will increase production capacity for next-generation metabolic treatments, leverage advanced biomanufacturing, automation, and digital tools, and aim to be operational by 2029. The project is expected to support more than 2,000 jobs (including 500+ high-wage manufacturing roles and 1,500+ construction jobs) and reinforces Roche and Genentech’s broader $50 billion U.S. manufacturing and R&D commitment.