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Vir (VIR), Glaxo's Xevudy Wins EC Approval for COVID-19
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Vir Biotechnology, Inc. (VIR - Free Report) and partner GlaxoSmithKline (GSK - Free Report) announced that the European Commission (“EC”) has granted marketing authorization to sotrovimab for the early treatment of COVID-19 under the brand name Xevudy.
Xevudy is now approved in the European Union (“EU”) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.
Approval was in the cards as the European Medicines Agency’s Committee for Medicinal Products for Human Use had given a positive opinion on the same on Dec 16.
The approval was based on positive data from the phase III study, COMET-ICE, which demonstrated that intravenous treatment with sotrovimab resulted in a 79% reduction (adjusted relative risk reduction) in all-cause hospitalizations for more than 24 hours or death due to any cause by day 29 compared to placebo.
Sotrovimab is authorized for emergency use in the United States. It has been granted conditional marketing authorization in Great Britain, provisional marketing authorization in Australia, among others.
Vir’s shares have gained 101.4% in the year so far against the industry’s decline of 19%.
Image Source: Zacks Investment Research
Vir and Glaxo had earlier reported preclinical data, which showed that sotrovimab retains activity against the rapidly spreading Omicron variant and all other currently tested variants of concern and interest. Shares surged on the same as the efficacy of vaccines is now under investigation amid this new variant of concern.
Vir and Glaxo announced a Joint Procurement Agreement (JPA) with the EC to supply up to 220,000 doses of sotrovimab in July 2021. With marketing grant in the EU, member states participating in the JPA can now order sotrovimab to support their pandemic responses.
Last month, both the companies announced U.S. government contracts totaling approximately $1 billion to purchase sotrovimab.
In April 2020, Glaxo and Vir entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2.
Meanwhile, Vir’s current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus (HIV)
It recently announced the first patient has been dosed in a phase II study evaluating novel therapeutic combinations for the treatment of chronic hepatitis B virus (HBV) infection. The multi-arm trial is being conducted in collaboration with Gilead Sciences, Inc. (GILD - Free Report) .
The study is evaluating various combinations of VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi); selgantolimod (GS-9688), Gilead’s investigational TLR-8 agonist; and Opdivo, an approved PD-1 inhibitor, in both nucleos(t)ide (NUC)-suppressed patients and viremic patients.
Estimates for Sarepta have narrowed from a loss per share of $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 60 days. SRPT delivered an earnings surprise of 11.06%, on average, in the last four quarters.
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Vir (VIR), Glaxo's Xevudy Wins EC Approval for COVID-19
Vir Biotechnology, Inc. (VIR - Free Report) and partner GlaxoSmithKline (GSK - Free Report) announced that the European Commission (“EC”) has granted marketing authorization to sotrovimab for the early treatment of COVID-19 under the brand name Xevudy.
Xevudy is now approved in the European Union (“EU”) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.
Approval was in the cards as the European Medicines Agency’s Committee for Medicinal Products for Human Use had given a positive opinion on the same on Dec 16.
The approval was based on positive data from the phase III study, COMET-ICE, which demonstrated that intravenous treatment with sotrovimab resulted in a 79% reduction (adjusted relative risk reduction) in all-cause hospitalizations for more than 24 hours or death due to any cause by day 29 compared to placebo.
Sotrovimab is authorized for emergency use in the United States. It has been granted conditional marketing authorization in Great Britain, provisional marketing authorization in Australia, among others.
Vir’s shares have gained 101.4% in the year so far against the industry’s decline of 19%.
Vir and Glaxo had earlier reported preclinical data, which showed that sotrovimab retains activity against the rapidly spreading Omicron variant and all other currently tested variants of concern and interest. Shares surged on the same as the efficacy of vaccines is now under investigation amid this new variant of concern.
Vir and Glaxo announced a Joint Procurement Agreement (JPA) with the EC to supply up to 220,000 doses of sotrovimab in July 2021. With marketing grant in the EU, member states participating in the JPA can now order sotrovimab to support their pandemic responses.
Last month, both the companies announced U.S. government contracts totaling approximately $1 billion to purchase sotrovimab.
In April 2020, Glaxo and Vir entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2.
Meanwhile, Vir’s current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus (HIV)
It recently announced the first patient has been dosed in a phase II study evaluating novel therapeutic combinations for the treatment of chronic hepatitis B virus (HBV) infection. The multi-arm trial is being conducted in collaboration with Gilead Sciences, Inc. (GILD - Free Report) .
The study is evaluating various combinations of VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi); selgantolimod (GS-9688), Gilead’s investigational TLR-8 agonist; and Opdivo, an approved PD-1 inhibitor, in both nucleos(t)ide (NUC)-suppressed patients and viremic patients.
Vir currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Sarepta Therapeutics, Inc. (SRPT - Free Report) , carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Sarepta have narrowed from a loss per share of $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 60 days. SRPT delivered an earnings surprise of 11.06%, on average, in the last four quarters.