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 (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.
Roche (RHHBY) announced FDA approval of Lunsumio VELO (mosunetuzumab) subcutaneous for adult patients with relapsed or refractory follicular lymphoma after two or more prior therapies, granted under accelerated approval on 22 December 2025.
Approval is based on the GO29781 trial where Lunsumio VELO showed an objective response rate 75% and complete response rate 59% in third-line or later FL, with a median duration of response of 22.4 months. The SC formulation reduces administration time to ~one minute versus 2–4 hour IV infusions and can be given as a fixed-duration regimen as short as six months. The most common adverse reactions included injection site reactions, fatigue, rash and cytokine release syndrome (CRS, 30%; Grade 3: 2.1%).
Genentech (OTCQX: RHHBY) announced FDA accelerated approval of Lunsumio VELO (mosunetuzumab-axgb) as a subcutaneous treatment for adult patients with relapsed or refractory follicular lymphoma after two or more prior systemic therapies, based on the Phase I/II GO29781 study.
Key trial results: ORR 75%, CR 59%, median duration of response 22.4 months. Administration is a ~one-minute subcutaneous injection versus a 2–4 hour IV infusion; treatment can be fixed-duration (as short as six months). Approval is accelerated and may require confirmatory trial verification. Common adverse reactions include injection site reactions, fatigue, rash and cytokine release syndrome (CRS) occurred in 30% (mostly Grade 1–2).
Genentech (OTCQX: RHHBY) announced an agreement with the U.S. government on December 19, 2025 that aims to lower prescription drug costs for state Medicaid programs, expand direct-to-patient access for its influenza medicines via TrumpRx.gov, and encourage other wealthy countries to reward biopharmaceutical innovation.
The company reaffirmed a $50 billion U.S. investment in manufacturing, infrastructure, and R&D, cited support for more than 11,000 jobs (including ~6,500 construction jobs) and up to 1,000 new skilled roles, and secured a three-year tariff exemption to enable continued onshoring. Specific agreement terms remain confidential.
Roche (OTCQX: RHHBY) announced U.S. launch of cobas 6800/8800 systems version 2.0 and software v2.0.1 after FDA 510(k) clearance earlier in 2025. The upgrade increases assay flexibility (unique assays per run 3→6), allows up to 6 assays per sample, and supports simultaneous LDT and IVD testing. A second analytic unit option for cobas 6800 can boost throughput to 2,112 tests/day. The update is available as a software upgrade to existing systems and aims to reduce downtime, consolidate test menus, and address staffing and cost pressures while modernizing the user interface.