Roche Hldg Stock Price, News & Analysis

Genentech presented updated results from the Phase III POLARIX study at the American Society of Hematology Annual Meeting, showcasing Polivy combined with R-CHP as a significant advancement in treating diffuse large B-cell lymphoma (DLBCL). After three years, progression-free survival (PFS) showed a statistically significant drop in disease worsening or death (HR 0.76). Quality of life metrics were comparable between Polivy and R-CHOP, with improvements sustained over 24 months. Polivy is now approved in over 50 countries for previously untreated DLBCL, pending a U.S. FDA decision by April 2023.

Roche (OTCQX: RHHBY) announced interim results from the phase III HAVEN 7 study, demonstrating that Hemlibra effectively controls bleeding in infants with severe haemophilia A without factor VIII inhibitors. The results show that 77.8% of participants experienced no bleeding episodes requiring treatment, and 42.6% reported no bleeds at all. These findings, presented at the 64th ASH Annual Meeting, support the early use of Hemlibra, which is already approved in over 100 countries. The study aims to highlight the treatment's safety and efficacy profile for infants.

Genentech has announced interim results from the Phase III HAVEN 7 study, revealing that Hemlibra® (emicizumab-kxwh) effectively prevents bleeding in infants with severe hemophilia A. Notably, 77.8% of participants experienced no bleeding episodes requiring treatment. The study included data from 54 infants and aims to confirm Hemlibra’s safety and efficacy. Data also support its favorable profile from real-world studies. Hemlibra is currently approved in over 100 countries for treating hemophilia A without factor VIII inhibitors.

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.