Regeneron Pharmaceuticals (REGN Quick QuoteREGN ) has posted a stellar performance so far in the year riding high on the strong demand for REGEN-COV (casirivimab and imdevimab), its antibody cocktail for COVID-19. The demand for the cocktail continues to increase as the pandemic keeps wreaking havoc with emerging deadly variants that question the efficacy of the vaccines.
Demand for antibody treatments is expected to remain strong in the near term as even vaccinated people are now being infected, sometimes even with severe COVID-19.
Regeneron fulfilled its second agreement with the U.S. government in the second quarter to manufacture and deliver 1.25 million doses of REGEN-COV at the lowest treatment dose authorized by the FDA, and in turn, recognized $2.59 billion in REG0EN-COV sales.
The company’s shares have gained 40.7% in the year so far compared with the industry’s growth of 2.8%.
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We remind investors that REGEN-COV was granted an Emergency Use Authorization (EUA) by the FDA for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing, and those at high risk of progression to severe COVID-19, including hospitalization or death. In June 2021, the FDA updated the EUA by lowering the dose to 1,200 mg and permitting administration by subcutaneous injection when intravenous infusion is not feasible.
The FDA also expanded the EUA to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19. These people are not fully vaccinated or are not expected to mount an adequate response to vaccination, and have been exposed to a SARS-CoV-2 infected individual or are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons).
In July 2021, Japan’s Ministry of Health, Labour and Welfare also approved the cocktail to treat patients with mild to moderate COVID-19, making it the first country to grant full approval for the antibody cocktail.
Last month, the U.K’s Medicines and Healthcare products Regulatory Agency also granted Conditional Marketing Authorization (CMA) to the cocktail under the brand name Ronapreve in the U.K. and other countries, to prevent and treat acute COVID-19 infection.
Regeneron has also submitted the first of two Biologics License Applications (BLAs) for REGEN-COV. The initial submission included data on the efficacy and safety of REGEN-COV to treat and prevent SARS-CoV-2 infection in non-hospitalized people. The second BLA submission, expected to be completed later this year, will focus on those hospitalized due to COVID-19.
Per a recent publication, REGEN-COV retains potency against the main variants of concern circulating within the United States and other countries such as the U.K., including Delta (B.1.617.2; first identified in India), Gamma (P.1; first identified in Brazil), and Beta (B.1.351; first identified in South Africa).
Regeneron has collaborated with Roche (RHHBY Quick QuoteRHHBY ) to increase the global supply of the cocktail.
The FDA has also granted an EUA to GlaxoSmithKline plc (GSK Quick QuoteGSK ) and Vir Biotechnology, Inc. (VIR Quick QuoteVIR ) ’s sotrovimab, an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients and the uptake has been encouraging.
Amid a surge in cases, especially in states like Florida in recent times, demand for these antibody treatments is expected to pick up further and boost the top line.
Regeneron currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.