Roche Hldg - RHHBY STOCK NEWS

Roche has received an extended marketing authorization for Actemra®/RoActemra® (tocilizumab) from the European Commission for treating severe COVID-19 in adults requiring oxygen or mechanical ventilation. This follows a positive recommendation from the EMA's Committee for Medicinal Products for Human Use (CHMP). Over 5,500 patients were involved in four pivotal phase III studies supporting this approval. This development emphasizes the urgent need for effective COVID-19 treatments and positions Actemra/RoActemra as a critical component in managing severe cases amidst the ongoing pandemic.

Roche has launched three automated digital pathology algorithms, uPath Ki-67 (30-9), uPath ER (SP1), and uPath PR (1E2), aimed at enhancing breast cancer diagnostics. These algorithms utilize deep learning to analyze tumor markers, improving the speed and accuracy of evaluations. Breast cancer, affecting approximately 2.3 million people globally in 2020, is a critical focus for Roche. This initiative aligns with their commitment to digital pathology, with the algorithms intended for research use only and integrated within Roche's digital pathology solutions.

Roche has completed the repurchase of 53,309,000 shares from Novartis, following resolutions passed at the Extraordinary General Meeting on 26 November 2021. This buyback is expected to enhance shareholder value and is aligned with Roche's strategic flexibility without impacting operational capabilities. The company maintains a mid-single-digit sales growth outlook for the year and aims for core EPS growth to follow suit. The dividend is also projected to increase, supporting the positive financial outlook for shareholders.

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.