Welcome to our dedicated page for Roche Hldg news (Ticker: RHHBY), a resource for investors and traders seeking the latest updates and insights on Roche Hldg stock.
Roche Holding Ltd/ADR (RHHBY) is linked to a stream of news that reflects the company’s activities in biotechnology, pharmaceuticals and diagnostics. Recent announcements from Roche and its U.S. affiliate Genentech highlight regulatory approvals, late‑stage clinical trial results, new diagnostic platforms and agreements related to access and manufacturing.
Investors and healthcare observers following RHHBY news will see updates on oncology and haematology programmes, such as the U.S. Food and Drug Administration’s accelerated approval of Lunsumio VELO, a subcutaneous CD20xCD3 bispecific antibody for relapsed or refractory follicular lymphoma after at least two prior lines of systemic therapy. News also covers Phase III data for the investigational oral SERD giredestrant in ER‑positive early‑stage breast cancer, as well as new data on Lunsumio combinations and long‑term outcomes in lymphomas presented at major scientific meetings.
On the diagnostics side, Roche has reported the U.S. launch of next‑generation cobas 6800/8800 systems and software upgrades, CE Mark approval for its cobas Mass Spec solution reagent pack for antibiotics drug monitoring, and CE Mark for the cobas BV/CV assay for bacterial vaginosis and candida vaginitis. These stories illustrate how the company is expanding its in‑vitro diagnostic menu and enhancing laboratory efficiency.
Additional news items include European Commission approval of Gazyva/Gazyvaro for lupus nephritis and Genentech’s agreement with the U.S. government addressing prescription drug costs and direct‑to‑patient programmes. For users of this page, the RHHBY news feed offers a central place to review such regulatory milestones, clinical trial readouts, product launches and policy‑related developments associated with Roche and the Roche Group.
Genentech, part of Roche, announced new data on Ocrevus (ocrelizumab) at the 38th ECTRIMS Congress from October 26-28, 2022. Findings include improved disease activity in treatment-naïve early-stage relapsing-remitting multiple sclerosis (RRMS) patients and significant pregnancy safety data from over 2,000 women. Long-term safety results reinforce Ocrevus' favorable benefit-risk profile. The research also examines the impact of misdiagnosis and delayed treatment in neuromyelitis optica spectrum disorder (NMOSD). Genentech aims to enhance treatment initiation and diagnosis accuracy for better patient outcomes.
Group sales for Roche increased by 2% at constant exchange rates and 1% in Swiss francs in the first nine months of 2022, totaling CHF 47 billion. The Pharmaceuticals Division reported stable sales but faced significant declines in COVID-19-related products, while sales in the Diagnostics Division rose by 6%. New product launches included Vabysmo and Xofluza. The company's outlook for 2022 remains stable, with expected low-single-digit sales growth and a projected increase in dividends. Significant challenges include declines in established drug sales due to biosimilars and the waning demand for COVID-19 treatments.
On October 12, 2022, Roche (OTCQX: RHHBY) unveiled its next-generation SARS-CoV-2 rapid antigen tests, enhancing its COVID-19 testing portfolio. The new tests, featuring improved performance and digital capabilities, provide results in as little as 15 minutes. Roche can produce tens of millions of tests monthly to meet global demand, with distribution beginning shortly. All tests can detect major variants, ensuring robust diagnostic capacity as the pandemic evolves. This initiative underscores Roche's commitment to delivering reliable healthcare solutions during ongoing challenges.
Roche (OTCQX: RHHBY) has announced promising new two-year data from the JEWELFISH study, demonstrating the efficacy of Evrysdi (risdiplam) in improving motor function in patients with Spinal Muscular Atrophy (SMA). Enrolling a diverse patient population, the study indicates that treatment with Evrysdi leads to a sustained increase in SMN protein levels and maintenance of motor function over two years. The safety profile remains consistent with previous studies, and the overall adverse event rate decreased significantly after the initial months of treatment.
Genentech has announced new two-year data from the JEWELFISH study for Evrysdi (risdiplam), showing significant improvements in motor function for patients with spinal muscular atrophy (SMA). The study featured a diverse group of 174 participants, many with severe disease characteristics. Evrysdi demonstrated sustained increases in SMN protein levels and a decrease in adverse events over time. With over 7,000 patients treated globally, Evrysdi continues to be a critical drug for SMA, offering hope for patients previously treated with other therapies. Data will be presented at the World Muscle Society Congress in October 2022.
Roche has launched the Anti-PRAME (EPR20330) Rabbit Monoclonal Primary Antibody, aimed at detecting PRAME protein expression in melanoma patients. This antibody helps differentiate benign from malignant lesions, enhancing diagnostic accuracy. Early detection of melanoma significantly improves survival rates, with localized cases showing a 99% five-year survival rate. The PRAME antibody is fully automated for various diagnostic instruments, adding to Roche's expansive dermatology portfolio of over 50 biomarkers. The announcement was made on October 11, 2022.
Roche announced new data regarding its neuromuscular portfolio to be showcased at the World Muscle Society Congress from October 11-15, 2022. Key highlights include promising efficacy data for Evrysdi in treating spinal muscular atrophy (SMA), with results from the RAINBOWFISH, FIREFISH, and SUNFISH studies. Additionally, the gene therapy delandistrogene moxeparvovec for Duchenne muscular dystrophy (DMD) showed sustained effectiveness in ongoing trials. New trials for generalised myasthenia gravis and facioscapulohumeral muscular dystrophy were also presented, underscoring Roche's commitment to addressing rare neuromuscular disorders.
Roche announced FDA approval for the PATHWAY anti-HER2/neu (4B5) test, enhancing the identification of metastatic breast cancer patients with low HER2 levels. This test allows patients to explore treatment options with ENHERTU, a HER2-targeted therapy, potentially improving outcomes for a previously underserved group, comprising nearly half of mBC patients. The DESTINY-Breast04 trial showed a 50% reduction in disease recurrence or death among those treated with ENHERTU based on the new testing criteria. Roche's commitment to diagnostics innovation is evident in this advancement.
On October 3, 2022, Roche announced the appointment of Matt Sause as CEO of Roche Diagnostics, effective January 1, 2023. Sause has a 20-year career at Roche, showcasing expertise in both Diagnostics and Pharma sectors across various regions. Thomas Schinecker, new Roche CEO, and Severin Schwan, proposed as Chairman, emphasized Sause's leadership capabilities. Roche, recognized for its sustainability efforts, is a leader in biotechnology and in-vitro diagnostics, aiming to enhance healthcare delivery globally.
Roche (OTCQX: RHHBY) announced the resignation of Julie Brown from its Board of Directors, effective immediately, as she has accepted a new management role at another pharmaceutical company. Brown, who served on the Board since March 2016 and chaired the Audit Committee, will be succeeded temporarily by Dr. Patrick Frost until the Annual General Meeting in March 2023. Roche Chairman Christoph Franz acknowledged Brown's significant contributions to the company, emphasizing her impact on Roche's success.