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

• The FDA has extended its review of Regeneron Pharmaceuticals Inc's (NASDAQ: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 (OTC: 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.