ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced that the European Medicines Agency's CHMP recommended expanding the marketing authorization for Actemra/RoActemra to treat severe COVID-19 in adults needing oxygen or ventilation. This decision was based on data from four phase III studies involving over 5,500 patients, showing a reduced risk of death. A final decision from the European Commission is expected soon, amid rising COVID-19 cases in Europe. Actemra has also received provisional approval in Australia and emergency use authorization in the U.S. and Ghana.

Roche has announced the upcoming launch of the SARS-CoV-2 & Flu A/B Rapid Antigen Test in January for professional use in CE Mark markets. This rapid test distinguishes between SARS-CoV-2 and influenza A/B within 30 minutes, featuring a sensitivity of 84.85% and specificity of 98.59% for COVID-19. The test integrates with NAVIFY® Pass, facilitating result sharing. Roche will seek Emergency Use Authorization (EUA) from the FDA in early 2022, marking a significant advancement in point-of-care testing amid the ongoing pandemic.

Roche has announced a significant change in its Board of Directors ahead of the Annual General Meeting (AGM) on 15 March 2022. Paul Bulcke will not stand for re-election after nearly 11 years. The board proposes Dr. Jemilah Mahmood for election, who brings considerable public health experience, particularly in less developed regions. Current members recommended for re-election include Christoph Franz, André Hoffmann, Julie Brown, and others. Roche continues to emphasize its commitment to advancing healthcare through innovation and sustainability.

Roche's subsidiary TIB Molbiol has launched three new testing kits aimed at detecting mutations in the Omicron SARS-CoV-2 variant, enhancing COVID-19 management strategies. These kits, which include VirSNip SARS Spike ins214EPE, VirSNiP SARS-CoV-2 Spike S371L S373P, and VirSNip SARS Spike E484A, can differentiate between the Omicron variant and others. Utilizing qPCR technology, they offer a crucial tool for researchers monitoring viral mutations. Roche's analysis confirms that existing PCR tests can accurately identify the Omicron variant, supporting ongoing efforts in vaccine development and public health interventions.

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.