Roche Hldg Stock Price, News & Analysis

Roche announced that the European Medicines Agency’s CHMP recommended expanding the marketing authorization for Hemlibra (emicizumab) to include prophylaxis for moderate haemophilia A without inhibitors. This follows positive results from the HAVEN 6 study, which showed effective bleed control and a favorable safety profile. Currently, only 15% of individuals with moderate haemophilia A live a bleed-free life. If approved, Hemlibra will provide an important treatment option for approximately 14% of the haemophilia A population in the EU.

Roche has announced a collaboration with Pfizer to enhance awareness and access to COVID-19 testing and treatment options in the U.S. Their Pilot® COVID-19 At-Home Test will now feature a QR code linking to covid19knowmore.com, providing vital health information. Approximately 90% of adults find personal health information difficult to understand, making this initiative crucial as winter approaches and COVID-19 cases may surge. The at-home test is authorized for individuals aged 14 and older and boasts a sensitivity of 93.2% and specificity of 100%.

Roche (RHHBY) presented updated clinical data on its bispecific antibodies, glofitamab and Lunsumio, at the ASH 2022 meeting. Glofitamab showed promising results in heavily pre-treated large B-cell lymphoma, with 61% of patients maintaining complete responses (CR) after 12 months. Lunsumio also exhibited high efficacy in relapsed follicular lymphoma, achieving a 60% CR rate. Both treatments are designed to offer fixed-duration therapies, enhancing patient outcomes and treatment convenience. Regulatory submissions for glofitamab are ongoing in Europe and the U.S.

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.