Regeneron is seeking full FDA approval for its monoclonal antibody for two types of COVID-19 patients
Shares of Regeneron Pharmaceuticals Inc.
gained 2.7% in premarket trading on Thursday after the company said the Food and Drug Administration accepted its application for approval of its monoclonal antibody treatment for non-hospitalized COVID-19 patients and as a prophylaxis for some people who have been exposed to the virus. The FDA said it will decide whether to approve the therapy by April 13 based on the priority review designation it granted to the application. It plans to hold an advisory committee meeting in advance of the decision. Regeneron said it plans to submit its monoclonal antibody treatment for FDA approval for hospitalized COVID-19 patients later this year. The treatment, Regen-Cov, has received emergency authorization for all three of these indications in the U.S. Regeneron’s stock is up 13.2% this year, while the broader S&P 500
has gained 16.2%.