Roche Hldg Stock Price, News & Analysis

Genentech, part of Roche Group (OTCQX: RHHBY), revealed promising clinical data for its bispecific antibodies, glofitamab and mosunetuzumab, at the ASH Annual Meeting 2022. The pivotal Phase II studies showed glofitamab induced durable responses in heavily pretreated large B-cell lymphoma, with 61% maintaining complete responses after 12 months. Meanwhile, mosunetuzumab demonstrated a 60% complete response rate in relapsed follicular lymphoma patients at a 27-month follow-up. Both treatments are under review by health authorities, including the FDA.

Roche announced updated data from the phase III POLARIX study at the 64th American Society of Hematology Annual Meeting. The study demonstrated a statistically significant reduction in the risk of disease worsening or death in patients with untreated diffuse large B-cell lymphoma (DLBCL) when treated with Polivy plus R-CHP compared to R-CHOP (HR 0.76). Improvements in health-related quality of life were similar for both treatments. Polivy has received approval in over 50 countries for DLBCL, with FDA decision expected by April 2, 2023.

Roche Holding Ltd has announced significant leadership changes ahead of its Annual General Meeting on 14 March 2023. Christoph Franz will not seek re-election as Chairman, with Severin Schwan proposed as the successor. Thomas Schinecker is set to become the new CEO effective the same date. New board members proposed include Mark Schneider and Prof. Akiko Iwasaki. Additionally, Bill Anderson will leave his role as CEO of Roche Pharmaceuticals at the end of December 2022, with Schinecker stepping in as interim CEO. Other executive transitions were also outlined in the release.

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.