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Vir (VIR) Announces Encouraging Data on COVID-19 Antibody
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Vir Biotechnology, Inc. (VIR - Free Report) recently announced that preclinical data suggest that its investigational monoclonal antibody sotrovimab retains neutralizing activity against the BA.2 subvariant of Omicron of the COVID-19 virus.
Sotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody. It is authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients in the United States. It has been granted marketing authorization in the European Union (EU), conditional marketing authorization in Great Britain, provisional marketing authorization in Australia.
Vir is developing sotrovimab with GlaxoSmithKline (GSK - Free Report) . In April 2020, GSK and Vir entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.
Vir stated that based on its pseudovirus and extensive pharmacokinetic data, it believes that the 500 mg dose of sotrovimab is sufficient to retain activity against the BA.2 variant like against all other variants of concern and interest.
The company will share the data with government and regulatory authorities worldwide.
Shares of Vir have lost 52.6% in the past year compared with the industry’s 38.3% decline.
Image Source: Zacks Investment Research
Last month, Glaxo and Vir announced the submission of an application to the FDA requesting an amendment to the Emergency Use Authorization (EUA) for sotrovimab to include intramuscular (IM) administration.
We note that the FDA earlier revised the authorizations for two monoclonal antibody treatments – Eli Lilly’s (LLY - Free Report) bamlanivimab and etesevimab (administered together) and Regeneron’s (REGN - Free Report) REGEN-COV (casirivimab and imdevimab).
Data showed that these treatments are highly unlikely to be active against the Omicron variant. Hence, the regulatory body has stated these treatments are no longer authorized for use in any U.S. states, territories and jurisdictions at this time. The agency also added that if patients in certain regions are likely to be infected or exposed to a variant susceptible to these treatments, then the use of these treatments may be authorized in these regions.
Sales of the antibody treatments had significantly boosted the top line of Regeneron and Eli Lilly in 2021, and this revision will adversely impact sales.
Earlier, the NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, also recommended against using LLY’s bamlanivimab and etesevimab and REGN’s REGEN-COV due to their markedly reduced activity against the Omicron variant.
Image: Bigstock
Vir (VIR) Announces Encouraging Data on COVID-19 Antibody
Vir Biotechnology, Inc. (VIR - Free Report) recently announced that preclinical data suggest that its investigational monoclonal antibody sotrovimab retains neutralizing activity against the BA.2 subvariant of Omicron of the COVID-19 virus.
Sotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody. It is authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients in the United States. It has been granted marketing authorization in the European Union (EU), conditional marketing authorization in Great Britain, provisional marketing authorization in Australia.
Vir is developing sotrovimab with GlaxoSmithKline (GSK - Free Report) . In April 2020, GSK and Vir entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.
Vir stated that based on its pseudovirus and extensive pharmacokinetic data, it believes that the 500 mg dose of sotrovimab is sufficient to retain activity against the BA.2 variant like against all other variants of concern and interest.
The company will share the data with government and regulatory authorities worldwide.
Shares of Vir have lost 52.6% in the past year compared with the industry’s 38.3% decline.
Last month, Glaxo and Vir announced the submission of an application to the FDA requesting an amendment to the Emergency Use Authorization (EUA) for sotrovimab to include intramuscular (IM) administration.
We note that the FDA earlier revised the authorizations for two monoclonal antibody treatments – Eli Lilly’s (LLY - Free Report) bamlanivimab and etesevimab (administered together) and Regeneron’s (REGN - Free Report) REGEN-COV (casirivimab and imdevimab).
Data showed that these treatments are highly unlikely to be active against the Omicron variant. Hence, the regulatory body has stated these treatments are no longer authorized for use in any U.S. states, territories and jurisdictions at this time. The agency also added that if patients in certain regions are likely to be infected or exposed to a variant susceptible to these treatments, then the use of these treatments may be authorized in these regions.
Sales of the antibody treatments had significantly boosted the top line of Regeneron and Eli Lilly in 2021, and this revision will adversely impact sales.
Earlier, the NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, also recommended against using LLY’s bamlanivimab and etesevimab and REGN’s REGEN-COV due to their markedly reduced activity against the Omicron variant.
Vir currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.