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 Diagnostics has launched the Pilot® COVID-19 At-Home Test, now available over-the-counter nationwide. This first over-the-counter test is designed for easy self-collection using an anterior nasal swab, delivering results in as little as 20 minutes. Authorized by the FDA under emergency use, the test boasts a relative sensitivity of 93.2% and a specificity of 100%. It is accessible at major retailers such as CVS and Amazon, enhancing testing convenience for individuals exposed to COVID-19. The initiative aligns with CDC guidance to mitigate virus spread.
Roche announced the early termination of the STRONG-HF study, demonstrating significant efficacy in reducing all-cause mortality and heart failure readmissions in patients after acute heart failure. The study highlighted the effectiveness of rapid up-titration of therapies and close follow-up, utilizing the Roche Elecsys NT-proBNP biomarker. Key results included an absolute risk reduction of 8.1% and a relative risk reduction of 34% in adverse outcomes at six months. Quality of life improved in the high-intensity care group. The findings could lead to a shift in heart failure management protocols.
Roche has launched its digital health portfolio under the navify brand, showcasing next-generation software solutions aimed at improving healthcare delivery. Debuted at HLTH 2022 in Las Vegas, the navify portfolio leverages analytics and data science to enhance operational processes and support clinical decision-making. The initiative aims to address interoperability issues in healthcare, potentially saving an estimated $30 billion in the US. Roche's commitment to personalized healthcare and digital transformation continues with over 30 digital solutions available globally.
Roche (OTCQX: RHHBY) announced significant findings from its haematology portfolio at the 64th ASH Annual Meeting. Key highlights include interim phase III HAVEN 7 data confirming Hemlibra’s efficacy for infants with severe haemophilia A, new data on Polivy's potential in diffuse large B-cell lymphoma, and promising results for bispecific antibodies Lunsumio and glofitamab. Additionally, crovalimab data shows efficacy in paroxysmal nocturnal haemoglobinuria. Roche focuses on innovative therapies addressing critical needs in blood disorders.
Genentech, part of Roche Group, announced new data from its hematology portfolio at the 64th ASH Annual Meeting, highlighting the efficacy of Hemlibra in infants with severe hemophilia A. New findings also support Polivy's potential in treating previously untreated diffuse large B-cell lymphoma (DLBCL). Additional insights were shared on bispecific antibodies mosunetuzumab and glofitamab, demonstrating promising results in lymphoma treatment. Furthermore, crovalimab showed effectiveness in paroxysmal nocturnal hemoglobinuria. These advancements emphasize Genentech's commitment to addressing unmet medical needs in blood disorders.
Roche has announced the upcoming U.S. launch of the cobas® 5800 System, a compact, fully automated molecular testing solution designed to enhance the diagnosis of infectious diseases. The cobas 5800 is FDA-approved for the cobas HIV-1 assay and aims to streamline workflows in labs of all sizes, delivering up to 144 results in eight hours. This new system addresses challenges faced by laboratories, including staffing shortages and increasing testing requirements. The cobas 5800 will be showcased at the Association for Molecular Pathology Annual Meeting in Phoenix, Arizona.
Roche announced positive topline results from its phase III studies, BALATON and COMINO, evaluating Vabysmo for treating macular edema due to retinal vein occlusion (RVO). Vabysmo achieved non-inferior visual acuity gains compared to aflibercept, with a safety profile consistent with previous trials. The treatment targets angiopoietin-2 and VEGF-A, offering a new option for RVO patients. Results will be submitted to regulatory authorities globally, with Vabysmo already approved in over 40 countries for other retinal conditions.
Genentech announced positive topline results from two Phase III studies, BALATON and COMINO, for its eye treatment Vabysmo (faricimab-svoa) in patients with macular edema due to retinal vein occlusion (RVO). Both studies met primary endpoints, demonstrating non-inferiority to aflibercept. Vabysmo showed rapid reduction in retinal fluid and was generally well tolerated, maintaining a safety profile consistent with prior trials. The results will be submitted to regulatory authorities and detailed at an upcoming medical meeting.
Roche (RHHBY) reports significant findings on its drug OCREVUS at the ECTRIMS Congress. A study revealed that 77% of early-stage relapsing-remitting multiple sclerosis (RRMS) patients achieved no evidence of disease activity after two years on OCREVUS. Initiating treatment early also reduced relapses, hospitalizations, and healthcare costs. Long-term safety data from over 5,800 patients confirmed a favorable benefit-risk profile, with no increased pregnancy risks observed in women treated with OCREVUS.
Genentech, a member of Roche Group (OTCQX: RHHBY), shared promising data on Ocrevus for early-stage relapsing-remitting multiple sclerosis (RRMS) patients. An interim analysis from the Phase IIIb ENSEMBLE study revealed that 77% of patients achieved no evidence of disease activity (NEDA) after two years. Initiating Ocrevus as a first-line treatment showed lower relapses, hospitalizations, and costs compared to second-line treatment. Long-term safety data extended over nine years demonstrated a consistent benefit-risk profile, while pregnancy outcomes showed no increased risk of adverse effects.
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