Regeneron Pharmaceuticals, Inc. ( REGN Quick Quote REGN - Free Report) announced positive initial results from an ongoing phase III study evaluating REGEN-COV (casirivimab and imdevimab antibody cocktail) used as a passive vaccine for the prevention of COVID-19 in people at high risk of infection (due to household exposure to a COVID-19 patient).
Shares of the company have rallied 12.6% in the past year compared with the
industry’s growth of 9%.
REGEN-COV is a cocktail of two monoclonal antibodies (casirivimab and imdevimab,also known as REGN10933 and REGN10987, respectively)and was designed specifically to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.
These antibodies can be administered to people via injection, providing passive immunity and immediately protecting the disease. However, they must be re-administered to remain effective over time. The study, which is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, is evaluating the use of REGEN-COV for immediate short-term passive immunity to prevent SARS-CoV-2 infection. Participants were randomly assigned to receive either REGEN-COV subcutaneously or placebo.
Interim findings showed that passive vaccination with REGEN-COV resulted in 100% prevention of symptomatic infection (n=0/186) compared with placebo (n=8/223) and approximately 50% lower overall rate of infection. Infections that occurred in the REGEN-COV arm were all asymptomatic, with decreased peak virus levels and short duration of viral shedding. These infections lasted not more than one week, while approximately 40% of infections in the placebo arm lasted three to four weeks.
In November 2020, REGEN-COV received an emergency use authorization (EUA) from the FDA for the treatment of mild to moderate COVID-19 patients who are at high risk of developing severe symptoms and requiring hospitalization and are not currently hospitalized.
Regeneron has collaborated with
Roche AG ( RHHBY Quick Quote RHHBY - Free Report) to increase the global supply of the cocktail. Regeneron is responsible for the development and distribution of the treatment in the United States and Roche is primarily responsible for the development and distribution outside the nation.
In January 2021,
Moderna, Inc.’s ( MRNA Quick Quote MRNA - Free Report) mRNA-based coronavirus vaccine candidate, mRNA-1273, was granted a conditional marketing authorization (CMA) by the European Commission. The vaccine can be administered for active immunization to prevent COVID-19 in individuals aged 18 years or older. It also received authorization in the United States and a few other countries. AstraZeneca’s ( AZN Quick Quote AZN - Free Report) adenovirus-based coronavirus vaccine candidate, AZD1222, received authorization for emergency use in the United Kingdom.
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