Roche Hldg - RHHBY STOCK NEWS

Roche announced that gantenerumab, an investigational antibody for early Alzheimer's disease, has received Breakthrough Therapy Designation from the FDA. This designation underscores the drug's potential, showing significant reduction in brain amyloid plaque in trials. Currently in Phase III development, the GRADUATE trials are set to evaluate the efficacy and safety of gantenerumab in over 2,000 participants, with completion expected in the second half of 2022. This could mark the first subcutaneous treatment for Alzheimer’s, aiming for at-home administration.

Roche announced that data for OCREVUS (ocrelizumab) and ENSPRYNG (satralizumab) will be presented at the 37th ECTRIMS Congress on October 13-15, 2021. Data shows OCREVUS provides sustained disability reduction for up to 8 years in primary progressive multiple sclerosis (PPMS) and 7.5 years in relapsing MS (RMS). Additionally, long-term safety analyses demonstrate a favorable benefit-risk profile for OCREVUS. ENSPRYNG shows sustained efficacy and safety over four years in neuromyelitis optica spectrum disorder (NMOSD). New studies exploring disease activity in treatment-naïve patients will also be highlighted.

Roche has announced positive results from the phase II/III 2066 study of Ronapreve™ (casirivimab and imdevimab) in hospitalized COVID-19 patients. The trial met its primary endpoint, demonstrating a significant reduction in viral load among seronegative patients not requiring supplemental oxygen (p=0.0172). The study complements prior findings from the UK's RECOVERY trial, showing numeric improvements across clinical endpoints. Despite these advancements, Ronapreve is not yet authorized for hospitalized COVID-19 patients. The compound is currently available in over 40 countries.

Roche presented new data at the World Muscle Society Congress on its neurological treatments, highlighting the efficacy of Evrysdi in treating spinal muscular atrophy (SMA) in pre-symptomatic babies. The RAINBOWFISH study showed that 80% of infants treated for 12 months achieved independent mobility, and all maintained swallowing ability. Evrysdi is now approved in 58 countries. Additionally, interim results on the investigational gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) showed lasting motor improvements, supporting further clinical studies.

Roche has launched three new PCR test panels for detecting respiratory pathogens, including influenza and RSV, from a single patient sample. This innovative approach utilizes syndromic testing to provide clinicians with actionable insights more quickly than traditional methods. The flexible testing option aims to optimize patient care by reducing unnecessary diagnostics while enabling targeted therapies. These tests can be integrated with Roche's existing COVID-19 testing solutions on the cobas® 6800/8800 Systems, enhancing operational efficiency amidst the ongoing need for respiratory disease management.

Roche presented new data at the ESMO Congress, highlighting Tecentriq's efficacy in treating early-stage lung cancer. The IMpower010 study showed a 34% reduction in disease recurrence or death among patients with Stage II-IIIA non-small cell lung cancer (NSCLC) expressing PD-L1≥1%. The FDA granted Tecentriq Priority Review as an adjuvant treatment, with a decision due by December 1, 2021. This groundbreaking data could significantly impact the treatment landscape for lung cancer and potentially boost Roche's market performance.

Roche announced the European Medicines Agency's CHMP recommendation for Gavreto (pralsetinib) as a monotherapy for adults with RET fusion-positive advanced non-small cell lung cancer (NSCLC). This marks a potential milestone, as it would be the first targeted treatment approved for first-line RET fusion-positive NSCLC in Europe. The recommendation is based on positive findings from the phase I/II ARROW study, which demonstrated significant clinical activity including a 79% overall response rate in treatment-naïve patients. A final decision from the European Commission is expected soon.

Roche has launched the Digital Pathology Open Environment, enhancing collaboration among software developers to improve personalized healthcare through advanced image analysis. This platform enables secure data exchange, allowing pathologists to access algorithms from third-party developers alongside Roche’s AI tools for improved diagnostic precision. By leveraging this open environment, Roche aims to foster partnerships and expedite the development of next-generation diagnostic tests, ultimately benefiting cancer patients with more targeted treatments.

Roche has announced its definitive agreement to acquire the TIB Molbiol Group, with the transaction expected to close in the fourth quarter of 2021. This acquisition aims to enhance Roche's molecular diagnostics portfolio, particularly in assays for infectious diseases, including SARS-CoV-2 variants. TIB Molbiol, recognized for its rapid assay development, has over 45 CE-IVD assays and more than 100 research use assays available on Roche’s LightCycler PCR systems. The two companies have collaborated for over 20 years, responding swiftly to biological threats.