Regeneron’s Antibody Gets Updated FDA Nod

Regeneron Pharmaceuticals’ (NASDAQ: REGN) investigational COVID-19 antibody cocktail, REGEN-COV (casirivimab and imdevimab), has received updated authorization for emergency use by the U.S. Food and Drug Administration (FDA). The EUA extension has been supported by the clinical data from multiple groups.

Notably, this first-of-its-kind COVID-19 antibody therapy is currently available across the U.S. for both treatment and post-exposure prophylaxis.

The updated authorization includes post-exposure prophylaxis in individuals who are at high risk of suffering severe COVID-19, are not fully vaccinated or are not likely to adequately respond to vaccination, and have been exposed to a SARS-CoV-2 infected individual, the company said.

Additionally, the authorization includes people who are at high risk of exposure to an infected individual, such as when the infection occurs within an institution (such as nursing homes or prisons). (See Regeneron stock charts on TipRanks)

Furthermore, people who require repeat doses for ongoing exposure can now receive doses monthly with REGEN-COV. Notably, the updated approval, which is applicable for people aged 12 and older, is in addition to the prior authorization to treat non-hospitalized patients.

Nevertheless, Regeneron stated that REGEN-COV cannot be considered as a substitute for vaccination against COVID-19, and is not authorized for pre-exposure prophylaxis to prevent COVID-19.

Regeneron’s Chief Scientific Officer George D. Yancopoulos said, “Today’s FDA decision to expand the use of REGEN-COV in post-exposure settings is a very helpful step, and we continue to work with the FDA as it undertakes its review of REGEN-COV in a broader group of people including in a pre-exposure prophylactic setting for people who are immunocompromised, and in patients hospitalized due to COVID-19.”

H.C. Wainwright analyst Michael King reiterated a Buy rating and lifted the stock’s price target to $729 (26.9% upside potential) from $703 after the company reported positive Ph3 results for Dupixent for chronic spontanous urticaria (hives), recently.

Furthermore, King updated his model to reflect higher expectations of success for Dupixent, and revised his revenue projections.

The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating. That’s based on 10 Buys versus 4 Holds. The average Regeneron price target of $656.08 implies 14.2% upside potential to current levels. Shares have increased 19% so far this year.