Roche Hldg - RHHBY STOCK NEWS

Genentech announced significant advances in its hematology portfolio at the American Society of Hematology (ASH) Annual Meeting from December 11-14, 2021. The Phase III POLARIX trial demonstrated that Polivy plus R-CHP significantly improved outcomes in newly diagnosed diffuse large B-cell lymphoma compared to standard treatments. Key findings on mosunetuzumab showed high response rates in relapsed follicular lymphoma patients. Additionally, interim data from the HAVEN 6 study indicated that Hemlibra is effective in patients with moderate to mild hemophilia A.

Roche has received conditional marketing authorization from the European Commission for Gavreto (pralsetinib) as a monotherapy for adults with RET fusion-positive advanced NSCLC who have not undergone prior treatment with a RET inhibitor. This approval is based on promising results from the ongoing phase I/II ARROW study, where Gavreto demonstrated a 72.0% overall response rate in treatment-naïve patients. Gavreto also shows potential across multiple solid tumor types and is part of Roche's expanding portfolio of precision medicines.

Roche has launched the cobas 5800 System, a new molecular laboratory instrument that enhances diagnostic capabilities for infectious diseases. This compact system offers efficiency and timely results, addressing the growing medical needs of patients worldwide. Designed for laboratories of all sizes, it automates the workflow for maximum productivity, providing up to 144 results in an eight-hour shift. Roche anticipates FDA approval in Q3 2022, which could further enhance its market presence.

Roche (OTCQX: RHHBY) received EU marketing authorization for Ronapreve™ (casirivimab and imdevimab) to treat and prevent COVID-19 in certain patients. This approval follows prior endorsements in Japan, the UK, and Australia. The decision was based on positive clinical trial data, indicating Ronapreve reduces hospitalization risk by 70% and symptomatic COVID-19 infections by 81%. Amid rising COVID-19 cases in Europe, Roche aims to collaborate with global regulators to expand Ronapreve's use for hospitalized patients.

Roche announced a positive recommendation from the EMA’s CHMP for the COVID-19 treatment Ronapreve (casirivimab and imdevimab). The antibody combination is recommended for use in adults and adolescents at risk of severe disease and for prevention post-exposure. Data from the REGN-COV 2067 and REGN-COV 2069 studies indicated a 70% reduction in hospitalizations or death and an 81% reduction in symptomatic infections, respectively. The final approval by the European Commission is awaited. Emergency authorizations are already in place in other regions.

Roche and Novartis have reached an agreement for Roche to repurchase 53.3 million shares from Novartis for approximately CHF 19 billion, at a price of CHF 356.9341 per share. The repurchase, subject to approval at an Extraordinary General Meeting on 26 November 2021, aims to enhance Roche's strategic flexibility and increase the free float from 16.6% to 24.9%. This move does not change control dynamics as family shareholders maintain majority voting rights. Roche projects mid-single-digit sales growth and aims to increase its dividend for 2021.

Roche's recent data from the IMPACT trial highlights the benefits of using the CINtec PLUS Cytology test for women at higher risk of cervical cancer. The trial, involving over 35,000 women, demonstrated that this dual-stain biomarker technology significantly outperforms Pap cytology in detecting cervical pre-cancer in HPV-positive women. With over 604,000 cervical cancer diagnoses globally each year, Roche aims to provide clinicians with effective tools to combat this preventable disease, emphasizing the importance of HPV screening.

Roche and Zur Rose Group have partnered to enhance diabetes management for 60 million Europeans living with the condition. The collaboration aims to provide people with diabetes and their caregivers with an integrated suite of services, including telemedicine, self-management products, and data visualization tools. Launching first in Germany in 2022, the program will target type 2 diabetes, which comprises 90% of cases. This venture positions Roche as a leader in personalized diabetes care, leveraging technology to improve patient outcomes and streamline care processes.