ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Genentech, a member of Roche Group (OTCQX: RHHBY), shared promising data on Ocrevus for early-stage relapsing-remitting multiple sclerosis (RRMS) patients. An interim analysis from the Phase IIIb ENSEMBLE study revealed that 77% of patients achieved no evidence of disease activity (NEDA) after two years. Initiating Ocrevus as a first-line treatment showed lower relapses, hospitalizations, and costs compared to second-line treatment. Long-term safety data extended over nine years demonstrated a consistent benefit-risk profile, while pregnancy outcomes showed no increased risk of adverse effects.

Roche has received FDA 510(k) clearance for its cobas SARS-CoV-2 Qualitative PCR test, marking a significant regulatory milestone. This test, designed for detecting COVID-19 in symptomatic patients, will remain available beyond the EUA period. It performs on the cobas 6800 and 8800 Systems, providing rapid results and enhanced operational efficiency. Roche's ongoing commitment to COVID-19 diagnostics includes adapting to evolving variants, ensuring continuous access to accurate testing for healthcare providers and patients alike.

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.