ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced that all proposals from its Board of Directors were approved at the Annual General Meeting held on 16 March 2021. Christoph Franz was re-elected as Chairman with 99.73% support. The company increased its dividend for the 34th consecutive year to CHF 9.10 per share. Despite pandemic challenges, Roche highlighted solid annual results and progress in its product pipeline, with 19 new active ingredients in late-stage development. Shareholders also approved the bonus amounts for executives and the remuneration for the Board, both receiving over 99% approval.

Roche announces the launch of the cobas SARS-CoV-2 Variant Set 1 Test for detecting key mutations in COVID-19 variants, including those from the UK, South Africa, and Brazil. This test supports research by enabling the assessment of variants' impact on diagnostics and therapeutics. Roche confirms that existing diagnostic tests remain effective against these mutations. The test operates on cobas 6800/8800 Systems and aims to enhance COVID-19 variant tracking, aiding public health responses.

Genentech, part of Roche Group (SIX: RO, ROG; OTCQX: RHHBY), released promising 2-year results from the SUNFISH study on Evrysdi™ (risdiplam) for Type 2 and non-ambulant Type 3 spinal muscular atrophy (SMA) in patients aged 2-25. Improvements in motor function achieved at 12 months were maintained or enhanced at 24 months across primary and secondary endpoints. The study, presented at the 2021 MDA Conference, showed no new safety signals. The findings reinforce Evrysdi's potential long-term benefits and favorable risk profile for SMA patients.

Roche announced new long-term data from the SUNFISH Part 2 study on Evrysdi (risdiplam) for Type 2 and non-ambulant Type 3 spinal muscular atrophy (SMA). The study shows that motor function improvements seen at 12 months were maintained or improved at 24 months, indicating sustained efficacy. The study, involving patients aged 2-25, demonstrated a favorable safety profile with no new safety signals. Evrysdi, the first at-home SMA treatment approved by the FDA, has treated over 2,500 patients in clinical and real-world settings.

Roche is set to acquire GenMark Diagnostics for US$ 24.05 per share, totaling approximately US$ 1.8 billion. This all-cash transaction represents a 43% premium over GenMark's stock price before acquisition rumors. The merger will enhance Roche's molecular diagnostics portfolio, particularly for infectious diseases, by incorporating GenMark’s ePlex platform. The acquisition is expected to close in the 2nd quarter of 2021, subject to regulatory approvals and shareholder tender.

Roche has announced that its cobas® HIV-1 and cobas® HCV Tests for the cobas® 6800/8800 Systems received WHO prequalification. This recognition aims to enhance access to reliable diagnostics in regions with limited healthcare resources, improving disease management for patients, particularly in the context of HIV and HCV. The Global Access Program, launched in 2014, aims to provide affordable diagnostic solutions and support WHO's 2030 goals for disease elimination. Roche's innovative cobas Plasma Separation Card further facilitates testing in remote settings.

Genentech announced that the global Phase III REMDACTA study of Actemra (tocilizumab) plus Veklury (remdesivir) for treating severe COVID-19 pneumonia did not meet its primary endpoint of improved hospital discharge time. No new safety signals were reported for Actemra. The study, conducted with Gilead Sciences, failed to meet key secondary endpoints as well. Previous studies COVACTA did not meet its primary endpoint, while EMPACTA did. Genentech remains committed to evaluating the overall data for potential application of Actemra in COVID-19 treatments.

Roche's REMDACTA clinical trial evaluating Actemra/RoActemra and Veklury for severe COVID-19 pneumonia failed to meet its primary endpoint of improved hospital discharge time. Neither did it meet key secondary endpoints, including mortality rates. No new safety concerns were raised during the trial. Roche plans to submit the results for peer-reviewed publication and continues to explore data from this and other COVID-19 studies involving Actemra. Currently, Actemra is not approved for treating COVID-19 pneumonia, despite ongoing evaluation of its potential role in certain patient scenarios.

Roche has received FDA approval for the VENTANA ALK (D5F3) CDx Assay, a companion diagnostic that identifies ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with LORBRENA® (lorlatinib). This assay is unique as the only FDA-approved immunohistochemistry test for LORBRENA. Previous studies showed ALK-positive patients treated with ALK inhibitors can achieve nearly three years of progression-free survival, compared to seven to eight months with chemotherapy. The assay also identifies more patients suitable for anti-ALK therapy than traditional FISH testing.