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Roche Holding Ltd. (RHHBY) reports healthcare developments across medicines, diagnostics and digital health, including updates from Genentech as a member of the Roche Group. Recurring news covers operating and financial results, regional sales trends, product performance and regulatory disclosures tied to the company’s pharmaceutical and diagnostic portfolios.
Company updates frequently feature ophthalmology products and pipeline assets such as Vabysmo, Susvimo and vamikibart across retinal conditions including diabetic macular edema and neovascular age-related macular degeneration. Roche also reports clinical data in neurology and autoimmune disease, including fenebrutinib in multiple sclerosis and ENSPRYNG in myelin oligodendrocyte glycoprotein antibody-associated disease, along with diagnostics approvals and patient-education initiatives.
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Roche has announced a collaboration with Pfizer to enhance awareness and access to COVID-19 testing and treatment options in the U.S. Their Pilot® COVID-19 At-Home Test will now feature a QR code linking to covid19knowmore.com, providing vital health information. Approximately 90% of adults find personal health information difficult to understand, making this initiative crucial as winter approaches and COVID-19 cases may surge. The at-home test is authorized for individuals aged 14 and older and boasts a sensitivity of 93.2% and specificity of 100%.
Roche (RHHBY) presented updated clinical data on its bispecific antibodies, glofitamab and Lunsumio, at the ASH 2022 meeting. Glofitamab showed promising results in heavily pre-treated large B-cell lymphoma, with 61% of patients maintaining complete responses (CR) after 12 months. Lunsumio also exhibited high efficacy in relapsed follicular lymphoma, achieving a 60% CR rate. Both treatments are designed to offer fixed-duration therapies, enhancing patient outcomes and treatment convenience. Regulatory submissions for glofitamab are ongoing in Europe and the U.S.
Genentech, part of Roche Group (OTCQX: RHHBY), revealed promising clinical data for its bispecific antibodies, glofitamab and mosunetuzumab, at the ASH Annual Meeting 2022. The pivotal Phase II studies showed glofitamab induced durable responses in heavily pretreated large B-cell lymphoma, with 61% maintaining complete responses after 12 months. Meanwhile, mosunetuzumab demonstrated a 60% complete response rate in relapsed follicular lymphoma patients at a 27-month follow-up. Both treatments are under review by health authorities, including the FDA.
Roche announced updated data from the phase III POLARIX study at the 64th American Society of Hematology Annual Meeting. The study demonstrated a statistically significant reduction in the risk of disease worsening or death in patients with untreated diffuse large B-cell lymphoma (DLBCL) when treated with Polivy plus R-CHP compared to R-CHOP (HR 0.76). Improvements in health-related quality of life were similar for both treatments. Polivy has received approval in over 50 countries for DLBCL, with FDA decision expected by April 2, 2023.
Roche Holding Ltd has announced significant leadership changes ahead of its Annual General Meeting on 14 March 2023. Christoph Franz will not seek re-election as Chairman, with Severin Schwan proposed as the successor. Thomas Schinecker is set to become the new CEO effective the same date. New board members proposed include Mark Schneider and Prof. Akiko Iwasaki. Additionally, Bill Anderson will leave his role as CEO of Roche Pharmaceuticals at the end of December 2022, with Schinecker stepping in as interim CEO. Other executive transitions were also outlined in the release.
Genentech presented updated results from the Phase III POLARIX study at the American Society of Hematology Annual Meeting, showcasing Polivy combined with R-CHP as a significant advancement in treating diffuse large B-cell lymphoma (DLBCL). After three years, progression-free survival (PFS) showed a statistically significant drop in disease worsening or death (HR 0.76). Quality of life metrics were comparable between Polivy and R-CHOP, with improvements sustained over 24 months. Polivy is now approved in over 50 countries for previously untreated DLBCL, pending a U.S. FDA decision by April 2023.
Roche (OTCQX: RHHBY) announced interim results from the phase III HAVEN 7 study, demonstrating that Hemlibra effectively controls bleeding in infants with severe haemophilia A without factor VIII inhibitors. The results show that 77.8% of participants experienced no bleeding episodes requiring treatment, and 42.6% reported no bleeds at all. These findings, presented at the 64th ASH Annual Meeting, support the early use of Hemlibra, which is already approved in over 100 countries. The study aims to highlight the treatment's safety and efficacy profile for infants.
Genentech has announced interim results from the Phase III HAVEN 7 study, revealing that Hemlibra® (emicizumab-kxwh) effectively prevents bleeding in infants with severe hemophilia A. Notably, 77.8% of participants experienced no bleeding episodes requiring treatment. The study included data from 54 infants and aims to confirm Hemlibra’s safety and efficacy. Data also support its favorable profile from real-world studies. Hemlibra is currently approved in over 100 countries for treating hemophilia A without factor VIII inhibitors.
Roche has announced successful results from the phase III COMMODORE 3 study for crovalimab, a treatment for paroxysmal nocturnal hemoglobinuria (PNH). The study met its primary endpoints, showing a 51.0% transfusion avoidance rate and 78.7% hemolysis control among participants. Crovalimab, an innovative anti-C5 recycling monoclonal antibody, is now under Priority Review for approval in China, aiming to provide critical treatment options for PNH patients where options are limited. The study included 51 patients, confirmed rapid improvements in fatigue, and had an excellent safety profile.