Roche Hldg Stock Price, News & Analysis

Roche has launched a new COVID-19 PCR test targeting the XBB.1.5 Omicron sub-variant, which is rapidly spreading in the U.S. and beyond. This test, named VirSNiP SARS-CoV-2 Spike F486P, is designed for research use and operates on the LightCycler® 480 II and cobas® z480 platforms. It aims to differentiate emerging variants and provide insights into their epidemiological impacts, aiding public health response strategies. The World Health Organization has expressed concerns over XBB.1.5's high transmissibility. Roche emphasizes its commitment to developing timely diagnostics to support healthcare communities globally, continuing its innovation in pandemic response.

Roche's Phase III IMbrave050 study has successfully met its primary endpoint of recurrence-free survival (RFS) for Tecentriq (atezolizumab) combined with Avastin (bevacizumab) in patients with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence post-surgery. This study underscores an urgent need for new treatments, as 70-80% of early-stage HCC patients face recurrence. Although overall survival data remains immature, safety profiles for both drugs align with established data. Roche plans to discuss findings with global health authorities and present results at future medical meetings.

Genentech, part of the Roche Group (OTCQX: RHHBY), announced that its Phase III IMbrave050 study successfully met the primary endpoint of recurrence-free survival (RFS) in patients with early-stage hepatocellular carcinoma (HCC) at high risk of disease recurrence after surgery. The combination of Tecentriq and Avastin showed statistically significant improvements compared to active surveillance. Currently, 70-80% of early-stage HCC patients face recurrence post-surgery, making this finding crucial. Further data discussions with health authorities, including the FDA and EMA, are anticipated as part of regulatory steps.

Roche's Xofluza (baloxavir marboxil) has received approval from the European Commission for treating uncomplicated influenza in children aged one and above, as well as for post-exposure prophylaxis. This marks the first single-dose oral antiviral for children in Europe and the first new mechanism of action for influenza treatment in nearly 20 years. The approval was based on positive Phase III miniSTONE-2 and BLOCKSTONE studies, demonstrating Xofluza's ability to reduce viral replication significantly faster than oseltamivir and effectively prevent influenza after exposure.

The FDA has accepted Roche's Biologics License Application for glofitamab, a bispecific antibody targeting large B-cell lymphoma. If approved by July 1, 2023, it will be the first fixed-duration therapy for patients with relapsed or refractory non-Hodgkin lymphoma. The pivotal NP30179 study reported a 40% complete response rate among heavily treated patients. Glofitamab is part of Roche's leading bispecific antibody portfolio, alongside the newly approved Lunsumio for follicular lymphoma. The drug shows promise with durable responses, though it has an associated risk of cytokine release syndrome.

Genentech announced the FDA’s acceptance of their Biologics License Application for glofitamab, a bispecific antibody aimed at treating relapsed or refractory large B-cell lymphoma (LBCL). If approved by July 1, 2023, it will be the first fixed-duration treatment for this aggressive cancer. In the Phase I/II NP30179 study, 40% of participants achieved complete response, with long-term remission observed. The drug is a part of an extensive bispecific antibody program, which includes the recently approved Lunsumio for follicular lymphoma.

Roche has received FDA approval for Lunsumio (mosunetuzumab-axgb), a groundbreaking treatment for adult patients with relapsed or refractory follicular lymphoma after two or more lines of therapy. This approval, based on the pivotal phase II GO29781 study, showed that 80% of patients achieved durable responses and 60% experienced complete remission. Lunsumio is the first CD20xCD3 T-cell engaging bispecific antibody approved for this indication, enabling chemotherapy-free and outpatient treatment. Continued approval is contingent upon further clinical benefit verification.

Genentech, part of the Roche Group (RHHBY), announced the FDA approval of Lunsumio (mosunetuzumab-axgb) for treating relapsed or refractory follicular lymphoma (FL) after two or more systemic therapies. This first-in-class CD20xCD3 T-cell engaging bispecific antibody offers a chemotherapy-free option with an outpatient administration. The pivotal Phase II GO29781 study revealed an 80% objective response rate and a 60% complete remission rate among heavily pretreated patients. Continued approval may depend on further confirmatory trials.

Roche has received FDA approval for Actemra (tocilizumab), the first monoclonal antibody to treat COVID-19 in hospitalized adults. This treatment targets patients on systemic corticosteroids needing oxygen support. With over one million patients treated worldwide, Actemra is now approved in more than 30 countries, marking its seventh FDA indication since 2010. The approval is based on extensive clinical trials, including the RECOVERY trial and EMPACTA trial.