Roche Hldg Stock Price, News & Analysis

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.

Roche has received 510(k) clearance from the U.S. FDA for its cobas® pure integrated solutions, a modular system aimed at improving productivity in low- to mid-volume laboratories. This new system combines clinical chemistry, immunoassay, and Ion-Selective Electrode testing into a compact footprint of about 21 square feet.

It can perform up to 870 tests per hour and will offer over 186 tests across various disease areas within the first year. Furthermore, it reduces hands-on maintenance to just five minutes per day, enhancing lab efficiency and patient care.