ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has successfully acquired 100% of TIB Molbiol Group, enhancing its diagnostics portfolio with over 45 CE-IVD assays and 100 research-use assays. This acquisition aims to strengthen Roche's capabilities in developing rapid diagnostic tests for emerging pathogens and health threats, like COVID-19. TIB Molbiol will operate as a subsidiary within Roche Diagnostics, continuing its research focus on urgent healthcare needs, including infectious diseases. The collaboration between the two companies spans over 20 years, highlighting their history of addressing critical healthcare challenges.

On 26 November 2021, Roche announced the approval of all proposals by its Board of Directors during an Extraordinary General Meeting. This included the approval of audited statutory interim financial statements as of 31 October 2021 and a share capital reduction through the cancellation of 53,309,000 bearer shares, facilitating the repurchase of shares from Novartis. The approval received overwhelming support from shareholders, with 100% approval for the financial statements and 99.85% for the share cancellation. The repurchase is expected to close in early December 2021.

Roche announced pivotal results from its hematology portfolio at the ASH Annual Meeting, enhancing treatment options for blood disorders. The Phase III POLARIX trial showed that Polivy plus R-CHP significantly improved outcomes for newly diagnosed DLBCL patients, marking a breakthrough in treatment over the past twenty years. Additionally, data on mosunetuzumab indicated strong response rates for relapsed follicular lymphoma, and interim results from the HAVEN 6 trial demonstrated the safety and efficacy of Hemlibra for moderate to mild hemophilia A patients.

Genentech announced significant advances in its hematology portfolio at the American Society of Hematology (ASH) Annual Meeting from December 11-14, 2021. The Phase III POLARIX trial demonstrated that Polivy plus R-CHP significantly improved outcomes in newly diagnosed diffuse large B-cell lymphoma compared to standard treatments. Key findings on mosunetuzumab showed high response rates in relapsed follicular lymphoma patients. Additionally, interim data from the HAVEN 6 study indicated that Hemlibra is effective in patients with moderate to mild hemophilia A.

Roche has received conditional marketing authorization from the European Commission for Gavreto (pralsetinib) as a monotherapy for adults with RET fusion-positive advanced NSCLC who have not undergone prior treatment with a RET inhibitor. This approval is based on promising results from the ongoing phase I/II ARROW study, where Gavreto demonstrated a 72.0% overall response rate in treatment-naïve patients. Gavreto also shows potential across multiple solid tumor types and is part of Roche's expanding portfolio of precision medicines.

Roche has launched the cobas 5800 System, a new molecular laboratory instrument that enhances diagnostic capabilities for infectious diseases. This compact system offers efficiency and timely results, addressing the growing medical needs of patients worldwide. Designed for laboratories of all sizes, it automates the workflow for maximum productivity, providing up to 144 results in an eight-hour shift. Roche anticipates FDA approval in Q3 2022, which could further enhance its market presence.

Roche (OTCQX: RHHBY) received EU marketing authorization for Ronapreve™ (casirivimab and imdevimab) to treat and prevent COVID-19 in certain patients. This approval follows prior endorsements in Japan, the UK, and Australia. The decision was based on positive clinical trial data, indicating Ronapreve reduces hospitalization risk by 70% and symptomatic COVID-19 infections by 81%. Amid rising COVID-19 cases in Europe, Roche aims to collaborate with global regulators to expand Ronapreve's use for hospitalized patients.

Roche announced a positive recommendation from the EMA’s CHMP for the COVID-19 treatment Ronapreve (casirivimab and imdevimab). The antibody combination is recommended for use in adults and adolescents at risk of severe disease and for prevention post-exposure. Data from the REGN-COV 2067 and REGN-COV 2069 studies indicated a 70% reduction in hospitalizations or death and an 81% reduction in symptomatic infections, respectively. The final approval by the European Commission is awaited. Emergency authorizations are already in place in other regions.