Roche Hldg Stock Price, News & Analysis

Roche has announced successful results from the phase III COMMODORE 3 study for crovalimab, a treatment for paroxysmal nocturnal hemoglobinuria (PNH). The study met its primary endpoints, showing a 51.0% transfusion avoidance rate and 78.7% hemolysis control among participants. Crovalimab, an innovative anti-C5 recycling monoclonal antibody, is now under Priority Review for approval in China, aiming to provide critical treatment options for PNH patients where options are limited. The study included 51 patients, confirmed rapid improvements in fatigue, and had an excellent safety profile.

Roche's Elecsys® Alzheimer’s disease CSF assays have received FDA 510(k) clearance, enhancing diagnosis accuracy for Alzheimer's patients over 55. These assays, available on cobas analyzers, offer lower costs and broader accessibility, aiming to diagnose up to 75% of undetected cases globally. They align with the demand for Alzheimer’s therapies and achieve 90% concordance with amyloid PET scans. By measuring key biomarkers, these tests facilitate early detection and potential treatment pathways, with scalability to meet future healthcare needs.

Roche received Emergency Use Authorization (EUA) from the FDA for its cobas® MPXV test, designed for the qualitative detection of monkeypox virus DNA in patient lesion swabs. This test, intended for use with cobas® 6800/8800 Systems, is notable because it evaluates actual patient samples rather than just laboratory-formulated samples. The dual-target approach enhances its reliability against mutations, enabling quicker diagnoses and treatment access, which is crucial as monkeypox symptoms mimic other illnesses.

Jnana Therapeutics has announced a second collaboration with Roche to discover small molecule drugs targeting cancer, immune-mediated, and neurological diseases. Under the agreement, Jnana will receive an upfront payment of $50 million and could earn milestone payments exceeding $2 billion. Jnana will focus on discovery and preclinical activities while Roche will handle development and commercialization. This partnership builds on their existing collaboration targeting SLC metabolite transporters, showcasing their strategic alignment in addressing high unmet medical needs.

Genentech, part of the Roche Group (RHHBY), reported that its Phase III GRADUATE I and II studies for the Alzheimer’s treatment gantenerumab failed to meet primary endpoints for slowing clinical decline in early Alzheimer’s patients. The beta-amyloid removal was lower than anticipated. Despite this setback, gantenerumab was well tolerated. Results of the study, involving 1,965 participants, showed non-significant clinical decline reductions of 8% and 6% in the two studies compared to placebo. Genentech remains committed to Alzheimer’s research and diagnostics.

Roche announced that its Phase III GRADUATE studies of gantenerumab in early Alzheimer’s disease did not meet primary endpoints for slowing clinical decline. The results showed a relative reduction in clinical decline of only 8% and 6% in two separate trials, which were not statistically significant. Additionally, the beta-amyloid removal levels were lower than anticipated. Despite these setbacks, Roche remains committed to the Alzheimer’s community and plans to present topline findings at the upcoming CTAD Conference on November 30, 2022.

Roche Diagnostics has launched the Pilot® COVID-19 At-Home Test, now available over-the-counter nationwide. This first over-the-counter test is designed for easy self-collection using an anterior nasal swab, delivering results in as little as 20 minutes. Authorized by the FDA under emergency use, the test boasts a relative sensitivity of 93.2% and a specificity of 100%. It is accessible at major retailers such as CVS and Amazon, enhancing testing convenience for individuals exposed to COVID-19. The initiative aligns with CDC guidance to mitigate virus spread.

Roche announced the early termination of the STRONG-HF study, demonstrating significant efficacy in reducing all-cause mortality and heart failure readmissions in patients after acute heart failure. The study highlighted the effectiveness of rapid up-titration of therapies and close follow-up, utilizing the Roche Elecsys NT-proBNP biomarker. Key results included an absolute risk reduction of 8.1% and a relative risk reduction of 34% in adverse outcomes at six months. Quality of life improved in the high-intensity care group. The findings could lead to a shift in heart failure management protocols.

Roche has launched its digital health portfolio under the navify brand, showcasing next-generation software solutions aimed at improving healthcare delivery. Debuted at HLTH 2022 in Las Vegas, the navify portfolio leverages analytics and data science to enhance operational processes and support clinical decision-making. The initiative aims to address interoperability issues in healthcare, potentially saving an estimated $30 billion in the US. Roche's commitment to personalized healthcare and digital transformation continues with over 30 digital solutions available globally.