Roche Hldg Stock Price, News & Analysis

Roche announced positive results from the phase III HAVEN 6 study for Hemlibra (emicizumab), showing that 66.7% of participants with moderate or mild haemophilia A experienced zero treated bleeds at an average follow-up of 55.6 weeks. The study also highlighted Hemlibra's consistent safety profile, with no new safety signals detected. Hemlibra is currently approved for use in over 110 countries for those with haemophilia A, including various treatment options to enhance patient outcomes.

Genentech announced positive results from the Phase III HAVEN 6 study of Hemlibra (emicizumab-kxwh), showing 66.7% of participants with moderate or mild hemophilia A experienced zero treated bleeds over a median follow-up of 55.6 weeks. The study demonstrated Hemlibra's favorable safety profile, with no new safety signals reported. Hemlibra is approved for treating hemophilia A in over 110 countries. The findings will support a submission to the European Medicines Agency for expanding the label to include non-severe hemophilia A patients.

Roche announced that the FDA accepted the Biologics License Application (BLA) for Lunsumio® (mosunetuzumab), a prospective first-in-class treatment for adults with relapsed or refractory follicular lymphoma (R/R FL). With high response rates in trials, Lunsumio could provide an outpatient treatment option without the need for genetic modifications. The FDA's decision is anticipated by December 29, 2022. The drug has previously received Breakthrough Therapy and Orphan Drug Designation, highlighting its potential impact.

Roche has announced the launch of the BenchMark ULTRA PLUS tissue staining system, designed to enhance laboratory diagnostics and improve workflow efficiency. This advanced platform provides quick and accurate results, vital for cancer diagnostics, which affect about 17 million new cases worldwide annually. The system will be available in EU countries from July 2022, followed by the US and Asia-Pacific markets in September 2022, and globally in 2023. Key innovations include intuitive software and environmentally sustainable features, aiming to support pathologists in delivering timely diagnoses.

Roche has launched the VENTANA DP 600, a high-capacity slide scanner designed for digital pathology, which enhances cancer diagnosis and treatment personalization. This next-generation scanner can process up to 240 slides, producing high-resolution images while improving laboratory workflows. The digital pathology solution aims to facilitate better collaboration and remote diagnostics, especially in underserved areas. Roche emphasizes that early cancer detection and effective treatment can save lives, addressing a critical global health issue where cancer claimed nearly 10 million lives in 2020.

Roche has launched a new HPV self-sampling solution in CE-mark-accepting countries, enabling women to privately collect samples for HPV screening at healthcare facilities. This initiative aims to improve access to cervical cancer screening, particularly in low- and middle-income countries where many cases are diagnosed at advanced stages. The solution aligns with Roche's commitment to the World Health Organization's strategy to eliminate cervical cancer. The cobas HPV test provides reliable results and can detect high-risk HPV types responsible for most cervical cancers.

Roche and Banner Alzheimer’s Institute reported that crenezumab failed to significantly slow cognitive decline in individuals with early-onset Alzheimer’s due to a specific genetic mutation. The study, part of a pioneering effort in Alzheimer’s prevention, involved 252 participants, 94% of whom completed the trial. Despite some numerical advantages for crenezumab across various measures, none were statistically significant. No new safety issues were found. Initial data will be presented at the Alzheimer's Association International Conference on August 2, 2022.

Roche has received Emergency Use Authorization (EUA) from the FDA for its cobas SARS-CoV-2 Duo test, a groundbreaking automated RT-PCR assay. This test provides both qualitative and quantitative results, enabling precise measurement of the viral load in COVID-19 patients. The test aims to enhance patient management by improving contact tracing and medical intervention strategies. By linking quantitative results to WHO standards, it facilitates consistent patient assessment across healthcare settings. The test will be available in the U.S. by Q2 2022.

Roche presented new long-term data at the EHA 2022 Congress, highlighting the effectiveness of its therapies for blood cancers. The phase III CLL14 study revealed that over 60% of previously untreated chronic lymphocytic leukaemia (CLL) patients remained in remission five years post-treatment with Venclexta plus Gazyva. Additionally, the final analysis of the phase III GALLIUM study demonstrated significant progression-free survival improvements with Gazyva plus chemotherapy for previously untreated follicular lymphoma patients.