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VIR Stock Down on Another Setback for COVID-19 Antibody
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Shares of Vir Biotechnology, Inc. (VIR - Free Report) were down 11.49% after the company and partner GlaxoSmithKline (GSK - Free Report) suffered another setback for its investigational monoclonal antibody sotrovimab for COVID-19.
The FDA has now determined that sotrovimab is no longer authorized for the treatment of COVID-19 given the absence of efficacy against the Omicron variant.
Last week, the FDA amended the Emergency Use Authorization (EUA) for sotrovimab based on new data, which showed that it was unlikely for sotrovimab 500 mg dose to be effective against the dominant Omicron BA.2 variant. Thereafter, the agency updated its website to exclude sotrovimab’s use in regions where the infection is caused by a non-susceptible SARS-CoV-2 variant based on available information, including variant susceptibility to these drugs and regional variant frequency (HHS regions 1 and 2).
The regulatory body has now extended the exclusion to all U.S. regions due to increases in COVID-19 cases caused by the Omicron BA.2 sub-variant.
Consequently, both Vir Biotechnology and Glaxo are preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant. They are sharing these data with regulatory and health authorities around the world for discussion.
Vir Biotechnology still expects to recognize approximately $1.1 billion of sotrovimab collaboration revenues when the antibody’s doses are delivered in the first half of the ongoing year. Both the companies still plan to submit a biologics license application (BLA) for sotrovimab to the FDA in the second half.
Vir Biotechnology and GSK also expect to commence two phase III studies in the second quarter to evaluate the use of sotrovimab in uninfected immunocompromised patients to determine whether it can prevent symptomatic COVID-19 infection.
Shares of Vir Biotechnology have plunged 47.7% in the year so far compared with the industry's 12.1% fall.
Image Source: Zacks Investment Research
The company is also developing VIR-2218 and VIR-3434 for chronic hepatitis B virus (HBV). Another candidate in the company’s pipeline is VIR-1111, an investigational subcutaneously administered HIV T cell vaccine based on human cytomegalovirus.
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 indicated that these treatments are highly unlikely to be active against the Omicron variant, which is dominant in the United States.
The regulatory body stated that these treatments are no longer authorized for use in any U.S. states, territories and jurisdictions at this time.
Sales of REGEN-COV had significantly boosted the top line of Regeneron, and this revision will adversely impact sales for now.
The regulatory body issued an EUA to Lilly’s bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant.
Image: Bigstock
VIR Stock Down on Another Setback for COVID-19 Antibody
Shares of Vir Biotechnology, Inc. (VIR - Free Report) were down 11.49% after the company and partner GlaxoSmithKline (GSK - Free Report) suffered another setback for its investigational monoclonal antibody sotrovimab for COVID-19.
The FDA has now determined that sotrovimab is no longer authorized for the treatment of COVID-19 given the absence of efficacy against the Omicron variant.
Last week, the FDA amended the Emergency Use Authorization (EUA) for sotrovimab based on new data, which showed that it was unlikely for sotrovimab 500 mg dose to be effective against the dominant Omicron BA.2 variant. Thereafter, the agency updated its website to exclude sotrovimab’s use in regions where the infection is caused by a non-susceptible SARS-CoV-2 variant based on available information, including variant susceptibility to these drugs and regional variant frequency (HHS regions 1 and 2).
The regulatory body has now extended the exclusion to all U.S. regions due to increases in COVID-19 cases caused by the Omicron BA.2 sub-variant.
Consequently, both Vir Biotechnology and Glaxo are preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant. They are sharing these data with regulatory and health authorities around the world for discussion.
Vir Biotechnology still expects to recognize approximately $1.1 billion of sotrovimab collaboration revenues when the antibody’s doses are delivered in the first half of the ongoing year. Both the companies still plan to submit a biologics license application (BLA) for sotrovimab to the FDA in the second half.
Vir Biotechnology and GSK also expect to commence two phase III studies in the second quarter to evaluate the use of sotrovimab in uninfected immunocompromised patients to determine whether it can prevent symptomatic COVID-19 infection.
Shares of Vir Biotechnology have plunged 47.7% in the year so far compared with the industry's 12.1% fall.
Image Source: Zacks Investment Research
The company is also developing VIR-2218 and VIR-3434 for chronic hepatitis B virus (HBV). Another candidate in the company’s pipeline is VIR-1111, an investigational subcutaneously administered HIV T cell vaccine based on human cytomegalovirus.
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 indicated that these treatments are highly unlikely to be active against the Omicron variant, which is dominant in the United States.
The regulatory body stated that these treatments are no longer authorized for use in any U.S. states, territories and jurisdictions at this time.
Sales of REGEN-COV had significantly boosted the top line of Regeneron, and this revision will adversely impact sales for now.
The regulatory body issued an EUA to Lilly’s bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant.
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.