ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche reported a 5% increase in group sales, reaching CHF 32.3 billion in the first half of 2022, driven by strong demand for new medicines and diagnostics. The Pharmaceuticals Division grew 3%, with significant contributions from products like Hemlibra and Ocrevus. The Diagnostics Division saw an 11% rise, bolstered by COVID-19 test sales. Net income rose by 12% to CHF 9.2 billion. Roche confirmed its outlook for 2022, anticipating stable sales growth while facing challenges from declining COVID-19 medicine sales and biosimilar competition, projecting a potential CHF 2.5 billion revenue loss from biosimilars.

Roche has received FDA Breakthrough Device Designation for its Elecsys Amyloid Plasma Panel, aimed at early detection of Alzheimer's disease. This innovative blood test measures biomarkers to facilitate timely diagnosis, addressing the urgent need, as up to 75% of symptomatic patients remain undiagnosed. The panel combines pTau 181 and APOE E4 assays, providing a non-invasive alternative to traditional methods. It enhances patient assessment, potentially streamlining access to confirmatory tests like PET scans, ultimately improving care for over 55 million people affected by dementia worldwide.

Roche has launched the Elecsys HCV Duo, a groundbreaking immunoassay for the simultaneous detection of hepatitis C virus (HCV) antigen and antibodies, available in CE Mark countries as of July 18, 2022. This dual detection enables earlier diagnosis and intervention in patients, aiming to curb disease progression and transmission. Approximately 58 million globally live with chronic HCV, with 290,000 annual fatalities, highlighting the urgent need for improved testing. The Elecsys HCV Duo is expected to enhance healthcare efficiency while addressing significant gaps in testing accessibility.

On July 14, 2022, Roche (OTCQX: RHHBY) released updated results from the phase III APHINITY study, showcasing the efficacy of the Perjeta-based regimen in treating HER2-positive early breast cancer. With a median follow-up of 8.4 years, a 28% reduction in recurrence or death was observed in lymph node-positive patients, translating to a 4.9% absolute benefit. While the safety profile remained consistent, overall survival data are still immature. The regimen is approved in over 100 countries and represents a significant advancement in cancer treatment for high-risk patients.

Roche (OTCQX: RHHBY) announced promising two-year results from the TENAYA and LUCERNE studies, highlighting the effectiveness of Vabysmo (faricimab) in treating neovascular age-related macular degeneration (nAMD). Over 60% of patients could be treated every four months, an increase from 45% at year one, while requiring a median of 10 injections compared to 15 for aflibercept. The treatment showed comparable vision gains and no new safety concerns, reinforcing its favorable benefit-risk profile. These results support Vabysmo's role in the evolving standards of care for retinal diseases.

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.