ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

On March 30, 2021, Roche announced the European Commission's approval of Evrysdi (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients aged two months and older. This decision, based on pivotal clinical trials FIREFISH and SUNFISH, marks a significant advancement in SMA treatment, enabling at-home administration. Over 3,000 patients have been treated with Evrysdi, and Roche is working with regulators in the EU to expedite patient access. The approval ensures availability across all 27 EU member states and is supported by favorable safety and efficacy data.

Roche has launched eight new configurations for its cobas pro integrated solutions, enhancing laboratory flexibility and efficiency. This new analyser can now process up to 4,400 tests per hour, effectively doubling previous capacities. The modifications allow labs to consolidate multiple analytical units on a single platform, ensuring faster turnaround times for patient samples. The cobas pro solutions cater to diverse testing needs in areas like cardiology and oncology, improving patient care through quicker diagnostics.

Roche announced positive results from the REGN-COV 2067 trial, demonstrating that the casirivimab and imdevimab antibody cocktail reduced the risk of hospitalization or death by 70% (1,200 mg) and 71% (2,400 mg) in non-hospitalized COVID-19 patients. The treatment also shortened symptom duration from 14 to 10 days. Ongoing studies include a phase II/III trial for hospitalized patients and another for prevention in household contacts. Over 25,000 individuals have participated in trials, and Roche aims for regulatory submissions soon.

Genentech, part of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced the discontinuation of dosing in the Phase III GENERATION HD1 study of tominersen for Huntington’s disease based on data reviewed by an Independent Data Monitoring Committee. While no new safety signals were identified, the study’s potential benefit/risk profile led to this decision. The open-label extension study (GEN-EXTEND) will also pause dosing for further analysis. Genentech aims to continue following participants for safety and outcomes, sharing insights within the HD community once full data is analyzed.

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.