Subsequent to discussions with regulatory authorities, Regeneron Pharmaceuticals (Nasdaq: REGN) says it has submitted a request to the US Food and Drug Administration for an Emergency Use Authorization (EUA) for its REGN-COV2 investigational antibody combination for the treatment of COVID-19.
News of Regeneron’s decision saw the firm’s shares gain more than 4% to $616.03 in pre-market trading today.
Under Regeneron’s agreement with the US government for the initial doses of REGN-COV2, if an EUA is granted, the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for around 50,000 patients, and the company expect to have doses available for 300,000 patients in total within the next few months.
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