Roche Hldg - RHHBY STOCK NEWS

Roche announced the discontinuation of dosing in the Phase III GENERATION HD1 study of tominersen for Huntington's disease, following a recommendation from an Independent Data Monitoring Committee. The iDMC determined the investigational therapy's benefit/risk profile was not favorable, although no new safety signals were identified. Roche will continue to follow participants for safety and clinical outcomes without administering the treatment. The open-label extension study GEN-EXTEND will also pause dosing as data analysis progresses.

Genentech, part of Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the Phase III IMpower010 study of Tecentriq^® (atezolizumab) met its primary endpoint of disease-free survival (DFS) in non-small cell lung cancer (NSCLC) patients at interim analysis. Significant DFS improvement was observed, especially in PD-L1-positive patients. Follow-up analyses will assess overall survival data. Tecentriq's safety profile remained consistent. Data will be presented at medical meetings and submitted to regulatory authorities for further evaluation.

Roche announced that its Phase III IMpower010 study evaluating Tecentriq (atezolizumab) significantly improved disease-free survival (DFS) in resectable early-stage lung cancer compared to best supportive care. The study involved 1,005 participants with non-small cell lung cancer (NSCLC). Follow-up will assess overall survival (OS) data, which was not mature at interim analysis. Safety results were consistent with known profiles. Roche aims to submit the data to global health authorities, including the U.S. FDA and EMA, for regulatory approval.

Roche has launched the cobas pure integrated solutions, a compact analyser designed for small to medium laboratories, offering over 230 diagnostic tests. With a footprint of just two square meters, it can perform up to 870 tests per hour while reducing technician maintenance time by 80%. This innovation aims to enhance workflow efficiency and patient care. The system's standardization with cobas pro analyzers allows for improved speed and accuracy in diagnostics.

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.