ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Genentech announced interim results from the Phase III HAVEN 6 study of Hemlibra for treating moderate or mild hemophilia A without factor VIII inhibitors. Data presented on December 12, 2021, indicate Hemlibra has a favorable safety profile, with 80.3% of participants reporting no bleeding episodes needing treatment. Additionally, 90.1% experienced no joint bleeds. The study involved 71 participants, confirming low annualized bleeding rates. Common adverse effects included headache (14.1%) and injection site reactions (12.7%), but there were no serious thrombotic events reported.

Roche announced promising new data on its bispecific antibody, mosunetuzumab, at the 63rd ASH Annual Meeting. Results from the pivotal phase I/II GO29781 study show a 60.0% complete response rate in patients with relapsed/refractory follicular lymphoma after two or more prior therapies, lasting at least 18 months. A median progression-free survival of 17.9 months and a duration of response of 22.8 months among responders were also reported. Roche aims to market this potential first-in-class treatment in Europe and the U.S..

Roche (RHHBY) announced promising results from the phase II CITYSCAPE trial for tiragolumab plus Tecentriq in patients with PD-L1-positive metastatic non-small cell lung cancer (NSCLC). After 2.5 years of median follow-up, the combination therapy demonstrated a 71% reduction in disease worsening compared to Tecentriq alone, with a median progression-free survival of 16.6 months. Overall survival also showed improvement, with a median of 23.2 months for the combination versus 14.5 months for Tecentriq. Tiragolumab, the first anti-TIGIT therapy to receive Breakthrough Therapy Designation, is under further development in multiple trials.

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.