Regeneron Pharmaceuticals Inc REGN is trading higher Thursday after the company announced the FDA accepted for priority review a Biologics License Application for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.
The FDA assigned a target action date of April 13, 2022 and plans to hold an advisory committee meeting to discuss the application beforehand.
The BLA is supported by two positive Phase 3 trials that evaluated the efficacy and safety of REGEN-COV to treat non-hospitalized patients already infected with SARS-CoV-2. A second BLA submission focused on the treatment of hospitalized patients is expected to be submitted later this year.
REGEN-COV is a cocktail of two monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-2.
Regeneron discovers, develops and commercializes products that fight eye disease, cardiovascular disease, cancer and inflammation.
REGN Price Action: Regeneron has traded as high as $686.62 and as low as $441 over a 52-week period.
The stock was up 1.50% at $555.34 at time of publication.
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