Roche Hldg Stock Price, News & Analysis

Roche has received Emergency Use Authorization (EUA) from the FDA for its COVID-19 At-Home Test, set to launch in January 2022. This rapid test allows individuals aged 14 and older to self-administer a nasal swab and obtain results within 20 minutes for SARS-CoV-2 and variants, including Omicron. Roche's collaboration with the NIH’s RADx initiative facilitated the rapid review process. The company plans to produce tens of millions of tests monthly to support the pandemic response, emphasizing the role of self-testing in public health. The test is the first rapid antigen test from Roche to receive EUA.

On December 17, 2021, Roche announced that its cobas® SARS-CoV-2 Qualitative test received CE mark approval for saliva sample use on the cobas® 6800/8800 Systems. This non-invasive testing method improves accessibility for COVID-19 screening, allowing individuals, including asymptomatic ones, to self-collect samples. The test detects SARS-CoV-2 RNA, including the Omicron variant, enhancing public health efforts in managing the pandemic. The cobas systems offer high throughput and automation, essential for labs during this critical time.

Roche has launched the first infectious disease tests on its new cobas® 5800 System in CE-mark-accepting countries. The tests include cobas® HIV-1, cobas® HBV, cobas® HCV, and cobas® HIV-1/HIV-2 Qualitative, enhancing Roche's molecular portfolio. This system improves laboratory efficiency and expands testing capabilities for various infectious diseases. Roche plans further CE approvals for additional tests, including cobas SARS-CoV-2, expected in early-to-mid 2022. The cobas 5800 System aims to make testing accessible worldwide while consolidating operational efficiencies.

Roche announced promising results from the phase III POLARIX study, demonstrating that Polivy combined with R-CHP significantly improves progression-free survival by 27% for patients with previously untreated diffuse large B-cell lymphoma (DLBCL) compared to the standard R-CHOP therapy. This breakthrough marks the first substantial treatment advance for DLBCL in over 20 years. The trial involved 879 patients, with results presented at ASH 2021 and published in NEJM. Roche aims to expedite global availability of this potential treatment option.

Roche has launched the AVENIO Edge System, an automated solution for next-generation sequencing (NGS) that enhances sample preparation workflows. This system aims to minimize human error and improve accuracy in sequencing results. Key features include a setup time of just 20 minutes, a 96% reduction in error opportunities, and an 84% decrease in hands-on time. RHHBY will provide laboratories with a scalable and cost-efficient solution designed for high performance in precision medicine. The AVENIO Edge System is set for global availability, with regulatory approvals in both the US and EU.

Roche announced interim results from the phase III HAVEN 6 study, demonstrating Hemlibra's favourable safety profile and effective bleed control in patients with moderate or mild haemophilia A without factor VIII inhibitors. The data, presented at the ASH Annual Meeting, indicated that 80.3% of participants experienced no bleeding episodes requiring treatment, while 90.1% had no joint bleeds. The study involved 71 participants, reinforcing that Hemlibra remains an effective prophylactic treatment and is approved in over 100 countries.

Genentech announced interim results from the Phase III HAVEN 6 study of Hemlibra for treating moderate or mild hemophilia A without factor VIII inhibitors. Data presented on December 12, 2021, indicate Hemlibra has a favorable safety profile, with 80.3% of participants reporting no bleeding episodes needing treatment. Additionally, 90.1% experienced no joint bleeds. The study involved 71 participants, confirming low annualized bleeding rates. Common adverse effects included headache (14.1%) and injection site reactions (12.7%), but there were no serious thrombotic events reported.

Roche announced promising new data on its bispecific antibody, mosunetuzumab, at the 63rd ASH Annual Meeting. Results from the pivotal phase I/II GO29781 study show a 60.0% complete response rate in patients with relapsed/refractory follicular lymphoma after two or more prior therapies, lasting at least 18 months. A median progression-free survival of 17.9 months and a duration of response of 22.8 months among responders were also reported. Roche aims to market this potential first-in-class treatment in Europe and the U.S..

Roche (RHHBY) announced promising results from the phase II CITYSCAPE trial for tiragolumab plus Tecentriq in patients with PD-L1-positive metastatic non-small cell lung cancer (NSCLC). After 2.5 years of median follow-up, the combination therapy demonstrated a 71% reduction in disease worsening compared to Tecentriq alone, with a median progression-free survival of 16.6 months. Overall survival also showed improvement, with a median of 23.2 months for the combination versus 14.5 months for Tecentriq. Tiragolumab, the first anti-TIGIT therapy to receive Breakthrough Therapy Designation, is under further development in multiple trials.