FDA Extends Review Period For Regeneron's COVID-19 Antibody Therapy

The FDA has extended its review of Regeneron Pharmaceuticals Inc's REGN marketing application of REGEN-COV (casirivimab and imdevimab) for non-hospitalized COVID-19 patients and as prophylaxis in certain individuals.
The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use. Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review.
The FDA has provided a new target action date of July 13, 2022, and has not requested any further studies.
In January 2022, FDA amended the EUA to exclude its use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment.
Therefore, REGEN-COV is not currently authorized for use in any U.S. state.
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies explicitly designed to block the infectivity of SARS-CoV-2, using Regeneron's proprietary VelocImmune and VelociSuite technologies.
Regeneron invented the antibody cocktail and is collaborating with Roche Holdings AG RHHBY, primarily responsible for development and distribution outside the U.S.
Price Action: REGN shares are trading 0.09% higher at $732.64 on the last check Thursday.