Why Did FDA Pull Authorization For GSK-Vir's COVID-19 Therapy? Read Here

• The U.S. health regulator said GlaxoSmithKline Plc (NYSE:GSK) and Vir Biotechnology Inc's (NASDAQ:VIR) antibody therapy was no longer authorized as a COVID-19 treatment.
• The decision was made as the CDC now estimates that the proportion of Covid-19 cases caused by BA.2 is above 50% nationwide.
• "Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in COVID-19 cases caused by the Omicron BA.2 sub-variant," the FDA said in a statement.
• Related: FDA Says Current Dose Of GSK-Vir's COVID-19 Therapy Unlikely To Work Against Omicron Subvariant.
• In a filing with the Securities and Exchange Commission, Vir Biotechnology said the companies were preparing a package of data to support the use of a higher dose of sotrovimab for the Omicron BA.2 sub-variant.
• Vir and GSK still expect to commence two Phase 3 trials this quarter to assess the use of sotrovimab in uninfected immunocompromised patients to determine whether sotrovimab can prevent symptomatic Covid infection.
• Price Action: GSK shares are up 1.86% at $45.40, and VIR stock is down 2.83% at $21.79 during the market session on the last check Wednesday.