Roche Hldg Stock Price, News & Analysis

Roche (OTCQX: RHHBY) announced significant findings on OCREVUS (ocrelizumab) ahead of the 38th ECTRIMS, highlighting its efficacy in slowing disease activity in treatment-naive early-stage relapsing-remitting multiple sclerosis (RRMS). The new data includes the largest pregnancy safety dataset for an anti-CD20 MS therapy, involving over 2,000 women, and nine-year safety data reinforcing OCREVUS's favorable risk-benefit profile. Roche also detailed advances in understanding misdiagnosis in neuromyelitis optica spectrum disorder (NMOSD) and the study design for a Phase III trial on satralizumab for MOGAD.

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.