Regeneron says FDA is still evaluating whether to fully approve its COVID-19 treatment

Regeneron Pharmaceuticals Inc. said Thursday that the Food and Drug Administration extended the review time by three months on whether to fully approve Regen-Cov as a treatment for non-hospitalized COVID-19 patients and as a prophylactic. Regeneron said the extension has to do with using Regen-Cov to prevent COVID-19 infections. Regen-Cov, which is a monoclonal antibody, was authorized as a COVID-19 treatment in November 2020; however, the therapy is not in use anywhere in the U.S. at this time because it is not effective against new variants. Regeneron’s stock has gained 15.9% so far this year, while the broader S&P 500 is down 5.8%.

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