ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has received European Commission approval for Polivy (polatuzumab vedotin) in combination with R-CHP for treating previously untreated diffuse large B-cell lymphoma (DLBCL). This first new treatment in over 20 years demonstrates a significant improvement in progression-free survival over the standard R-CHOP regimen, with a 27% reduction in disease progression risk. The approval was grounded in the pivotal POLARIX study results, showing comparable safety profiles. Roche aims to alleviate DLBCL burdens on patients and healthcare systems.

Roche and its subsidiary TIB Molbiol have launched three LightMix® Modular Virus kits designed for the detection of the monkeypox virus amid rising cases in non-endemic countries. The kits will aid in assessing the spread of the virus and support public health measures. The first kit detects orthopoxviruses, while the second targets only monkeypox viruses. A third kit simultaneously identifies both, enhancing research capabilities. These test kits will be available for research use globally.

Roche (OTCQX: RHHBY) announced significant findings to be presented at the 2022 ASCO Annual Meeting, focusing on innovative cancer treatments. Key highlights include data on glofitamab, a bispecific antibody designed for aggressive lymphoma, and its phase II trial results. Further presentations will cover genomic testing in cancer treatment, as well as updates on various oncology therapies, showcasing Roche's commitment to advancing personalized cancer care and improving patient outcomes.

Roche (OTCQX: RHHBY) has partnered with The Global Fund to enhance diagnostic capabilities in low- and middle-income countries (LMICs), targeting infectious diseases like tuberculosis (TB) and HIV. The collaboration aims to improve access to diagnostics, helping millions of undiagnosed individuals. Currently, about 2 billion people are estimated to have TB, with a significant portion of TB fatalities occurring in LMICs. The COVID-19 pandemic has further disrupted healthcare programs, intensifying the need for immediate action in diagnostics to save lives.

The Phase III SKYSCRAPER-01 study of tiragolumab plus Tecentriq did not meet its co-primary endpoint of progression-free survival for treating non-small cell lung cancer (NSCLC). While the overall survival endpoint remains immature, the study will continue until the next analysis. Although the results were disappointing, numerical improvements were noted in both co-primary endpoints, and the combination treatment was well-tolerated, with no new safety signals. Ongoing trials aim to explore tiragolumab's potential in NSCLC and other cancers.

Roche's phase III SKYSCRAPER-01 study evaluating tiragolumab alongside Tecentriq for advanced non-small cell lung cancer (NSCLC) did not achieve its co-primary endpoint of progression-free survival. While overall survival data is still maturing, the study will proceed to further analysis. Despite these setbacks, tiragolumab continues to be explored in various cancer types, indicating Roche's commitment to developing this investigational therapy.

Roche has extended its commitment to the World Federation of Hemophilia's Humanitarian Aid Program until 2028, aiming to provide prophylactic treatment for up to 1,000 individuals with haemophilia A in underserved regions. This initiative, launched in February 2019, has already benefited over 940 people across 30 countries. The program addresses critical access issues for individuals with bleeding disorders, particularly in developing nations where standard care is limited. Roche has been recognized as a Visionary Contributor to the program, emphasizing its dedication to improving health outcomes for affected populations.

Roche (OTCQX: RHHBY) announced new three-year data from the FIREFISH study, showing that 91% of infants treated with Evrysdi (risdiplam) are alive after three years. The study indicates significant improvements in motor functions, including the ability to sitting without support and swallowing. The treatment demonstrated a reduction in serious adverse events and hospitalizations, with notable ongoing efficacy in over 5,000 patients. Evrysdi is now approved in 79 countries and under review in 29 more.

Roche reported a 11% increase in Group sales during Q1 2022, reaching CHF 16.4 billion. The Pharmaceuticals Division grew by 6%, driven by new medicines for severe diseases, while the Diagnostics Division surged 24%, largely due to high demand for COVID-19 tests. Significant developments included FDA approval of Vabysmo for eye diseases and EU recommendations for Polivy and Tecentriq for cancer treatments. Roche confirms its full-year outlook, projecting stable sales growth, although sales from COVID-19 products are expected to decline.