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Regeneron Covid Antibody Treatment Accepted for FDA Review

Regeneron shares rose after the FDA accepted for review its monoclonal antibody treatment for non-hospitalized Covid patients.
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Regeneron Pharmaceuticals  (REGN) - Get Regeneron Pharmaceuticals, Inc. Report shares rose Thursday after the FDA accepted for review the company’s monoclonal antibody treatment for non-hospitalized Covid patients.

The Food and Drug Administration also agreed to review the drugs as a preventive measure for some people exposed to the virus.

“The FDA has accepted for priority review a biologics license application for Regen-Cov," generically casirivimab and imdevimab, Regeneron said.

“The FDA has assigned a target action date of April 13, 2022, and informed us that they currently are planning to hold an advisory committee meeting to discuss this application.”

Regeneron recently traded at $559.40, up 2.2%. It's up 15% over the past six months amid enthusiasm for its Covid treatment. But the stock has slumped 14% in the past month on valuation concern.

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“In the U.S., Regen-Cov … is currently authorized under an emergency-use authorization to treat people with mild to moderate Covid-19 who are at high risk of serious consequences from Covid-19 infection,” the company said.

In September Regeneron unveiled a new agreement with the U.S. government to supply an additional 1.4 million doses of Regen-Cov by January 2022.

Morningstar analyst Karen Andersen puts fair value for the company at $570.

“Regeneron has leveraged its monoclonal antibody research and development platform to become one of the few biotechs to successfully emerge as a profitable commercial operation and establish a narrow moat,” she wrote last month.

The moat stems from the “intangible assets that underlie the commercial potential of Eylea and its pipeline drugs and the exceptional productivity of its monoclonal antibody … platform.” Eylea treats wet age-related macular degeneration and other disorders.