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Vir Biotech (VIR)/Glaxo COVID-19 Drug Cuts Hospitalization Risk
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Vir Biotechnology, Inc. (VIR - Free Report) , along with its British partner GlaxoSmithKline (GSK - Free Report) , announced interim data from the phase III COMET-ICE study evaluating their monoclonal antibody candidate, VIR-7831, as a monotherapy for the early treatment of COVID-19 in adults who are at high risk of hospitalization.
The interim data showed that treatment with VIR-7831 monotherapy led to 85% reduction in hospitalization or death as compared to placebo – the primary endpoint of the COMET-ICE study.
Based on the positive interim data, an Independent Data Monitoring Committee (“IDMC”) recommended that the study be stopped early as there was evidence of profound efficacy.
Vir Biotechnology and Glaxo are planning to file an Emergency Use Authorization (“EUA”) application for VIR-7831 to the FDA, as well as to other regulatory authorities for authorizations in other countries based on the above study data.
Noatbly, results from this registrational study will also support the filing of a biologics license application (BLA) submission for VIR-7831 to the FDA.
Shares of Vir Biotechnology were up 32.1% following the announcement of the news on Thursday. In fact, the stock has skyrocketed 130.8% so far this year against the industry’s decrease of 0.5%.
Importantly, additional new in vitro studies on VIR-7831 have indicated that the candidate maintains activity against currently circulating new variants of the COVID-19 virus, including the U.K., South African and Brazilian variants.
We remind investors that in October 2020, Vir Biotechnology and Glaxo decided to begin phase III testing of VIR-7831 following a positive assessment of safety and tolerability data from the lead in portion of the phase II COMET-ICE study by an IDMC.
Notably, monoclonal antibodies directed against the SARS-CoV-2 virus have the potential to provide effective immune response to COVID-19.
Please note that, in February, pharma giant Eli Lilly (LLY - Free Report) announced a deal with Vir Biotech and Glaxo to evaluate its antibody drug bamlanivimab (700mg) with VIR-7831 (500mg) in low-risk patients with mild-to-moderate COVID-19.
Notably, bamlanivimab was granted EUA by the FDA in November 2020 as a monotherapy for high-risk patients recently diagnosed with mild-to-moderate COVID-19. Bamlanivimab alone is now authorized for emergency/temporary use in numerous countries.
Meanwhile, in February 2021, the FDA granted EUA to a combination of bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19.
The FDA also granted EUA to Lilly and Incyte’s (INCY - Free Report) oral JAK inhibitor Olumiant for use in combination with Gilead’s remdesivir to treat hospitalized COVID-19 patients in November 2020.
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Vir Biotech (VIR)/Glaxo COVID-19 Drug Cuts Hospitalization Risk
Vir Biotechnology, Inc. (VIR - Free Report) , along with its British partner GlaxoSmithKline (GSK - Free Report) , announced interim data from the phase III COMET-ICE study evaluating their monoclonal antibody candidate, VIR-7831, as a monotherapy for the early treatment of COVID-19 in adults who are at high risk of hospitalization.
The interim data showed that treatment with VIR-7831 monotherapy led to 85% reduction in hospitalization or death as compared to placebo – the primary endpoint of the COMET-ICE study.
Based on the positive interim data, an Independent Data Monitoring Committee (“IDMC”) recommended that the study be stopped early as there was evidence of profound efficacy.
Vir Biotechnology and Glaxo are planning to file an Emergency Use Authorization (“EUA”) application for VIR-7831 to the FDA, as well as to other regulatory authorities for authorizations in other countries based on the above study data.
Noatbly, results from this registrational study will also support the filing of a biologics license application (BLA) submission for VIR-7831 to the FDA.
Shares of Vir Biotechnology were up 32.1% following the announcement of the news on Thursday. In fact, the stock has skyrocketed 130.8% so far this year against the industry’s decrease of 0.5%.
Importantly, additional new in vitro studies on VIR-7831 have indicated that the candidate maintains activity against currently circulating new variants of the COVID-19 virus, including the U.K., South African and Brazilian variants.
We remind investors that in October 2020, Vir Biotechnology and Glaxo decided to begin phase III testing of VIR-7831 following a positive assessment of safety and tolerability data from the lead in portion of the phase II COMET-ICE study by an IDMC.
Notably, monoclonal antibodies directed against the SARS-CoV-2 virus have the potential to provide effective immune response to COVID-19.
Please note that, in February, pharma giant Eli Lilly (LLY - Free Report) announced a deal with Vir Biotech and Glaxo to evaluate its antibody drug bamlanivimab (700mg) with VIR-7831 (500mg) in low-risk patients with mild-to-moderate COVID-19.
Notably, bamlanivimab was granted EUA by the FDA in November 2020 as a monotherapy for high-risk patients recently diagnosed with mild-to-moderate COVID-19. Bamlanivimab alone is now authorized for emergency/temporary use in numerous countries.
Meanwhile, in February 2021, the FDA granted EUA to a combination of bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19.
The FDA also granted EUA to Lilly and Incyte’s (INCY - Free Report) oral JAK inhibitor Olumiant for use in combination with Gilead’s remdesivir to treat hospitalized COVID-19 patients in November 2020.
Zacks Rank
Vir Biotechnology currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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With super high data speed, it will make current cell phones obsolete and unlock the full potential of big data, cloud computing, and artificial intelligence. In the next few years this industry is predicted to create 22 million jobs and a stunning $12.3 trillion in revenue.
Today you have an historic chance to pursue almost unimaginable gains like Microsoft, Netflix, and Apple in their early phases. Zacks has released a Special Report that reveals our . . .
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