ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced that its Phase III GRADUATE studies of gantenerumab in early Alzheimer’s disease did not meet primary endpoints for slowing clinical decline. The results showed a relative reduction in clinical decline of only 8% and 6% in two separate trials, which were not statistically significant. Additionally, the beta-amyloid removal levels were lower than anticipated. Despite these setbacks, Roche remains committed to the Alzheimer’s community and plans to present topline findings at the upcoming CTAD Conference on November 30, 2022.

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.

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 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.