ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced positive long-term efficacy results for ENSPRYNG (satralizumab) in preventing relapses in patients with neuromyelitis optica spectrum disorder (NMOSD). Data from the SAkuraStar and SAkuraSky studies show that over 70% of treated individuals remained relapse-free after four years. With a favorable safety profile, ENSPRYNG is now approved in 58 countries, including the U.S. and the EU. New studies, like SAkuraBONSAI, are being initiated to further evaluate its effectiveness and safety.

Roche has received European Medicines Agency (EMA) approval for a 90-minute infusion of Gazyvaro® (obinutuzumab), a significant reduction from the standard 3-4 hour infusion time. This change aims to enhance patient convenience and reduce healthcare system pressures, especially post-COVID-19. The GAZELLE study confirmed no new safety concerns with the shorter infusion. Gazyvaro is already approved for treating follicular lymphoma (FL) and other indications, further solidifying its role in improving patient treatment experiences.

Roche announced significant long-term data on OCREVUS, highlighting a 35% reduction in the risk of needing a walking aid in relapsing multiple sclerosis (RMS) after 7.5 years versus later initiation. There is also a 29% reduction in disability progression in primary progressive MS (PPMS) seen after 8 years. The data, demonstrating a consistent benefit-risk profile, will be presented at the ECTRIMS Congress. Additionally, a shorter 2-hour infusion of OCREVUS was well-tolerated across diverse populations. The outcome reaffirms Roche's commitment to investigate the impacts of COVID-19 in patients treated with OCREVUS.

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.