GlaxoSmithKline plc and Vir Biotechnology…today announced that the US Food and Drug Administration has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab, an investigational monoclonal antibody. The FDA has determined that, based on the totality of available evidence, including new live virus data generated by Vir, it is unlikely that the sotrovimab 500 mg dose will be effective against the Omicron BA.2 variant.
GSK and Vir are preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant and will be sharing these data with regulatory and health authorities around the world for discussion.
This PR was issued after the close, but the market apparently got wind of the FDA decision about 3:45pm ET.
The above had essentially no effect on GSK’s share price.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”