Regeneron Pharmaceuticals, Inc. ( REGN Quick Quote REGN - Free Report) announced positive data from a late-stage study (2069B) of recently infected asymptomatic COVID-19 patients, which is evaluating the antibody cocktail REGEN-COV (casirivimab with imdevimab) 1,200 mg administered via subcutaneous (SC) administration.
The phase III study enrolled 204 individuals without any COVID-19 symptoms who tested positive for SARS-CoV-2 but did not have anti-virus antibodies at baseline and were randomized to receive either 1 dose of REGEN-COV (1,200 mg) or placebo.
The cocktail reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint), and by 76% after the third day. Data also showed that REGEN-COV shortened symptom duration and markedly reduced viral levels. The study met all primary and key secondary endpoints. Moreover, the total number of weeks for which patients experienced symptoms was nearly cut in half (45%) with REGEN-COV, and the viral burden was reduced by more than 90%.
Separately, Regeneron also announced that the phase III study (2069A) evaluating the ability of REGEN-COV to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals met its primary and key secondary endpoints. The phase III double-blind, placebo-controlled trial evaluated the effect of REGEN-COV on uninfected individuals without anti-SARS-CoV-2 antibodies or any COVID-19 symptoms, who lived in the same household where an individual has tested positive for SARS-CoV-2 within the prior four days. The study enrolled 1,505 people who were not infected with SARS-CoV-2 at baseline and randomized to receive either 1 dose of REGEN-COV (1,200 mg) or placebo, administered as SC injections.
Results of the study showed that REGEN-COV 1,200 mg administered SC reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial. REGEN-COV rapidly protected household contacts from exposure to SARS-CoV-2 at home, with 72% protection against symptomatic infections in the first week and 93% in subsequent weeks.
We remind investors that REGEN-COV has been granted Emergency Use Authorization by the FDA to treat mild-to-moderate COVID-19 in adults, as well as pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.
Regeneron now plans to share these encouraging data with the FDA and request an EUA expansion to include COVID prevention for appropriate populations, using a 1,200 mg subcutaneous dose.
Earlier, the company announced that its phase III outcomes trial on REGEN-COV (casirivimab with imdevimab) in high-risk non-hospitalized COVID-19 patients was successful.
Regeneron’s shares have lost 1.6% in the year so far compared with the
industry’s decline of 6.8%.
It has a collaboration agreement with
Roche ( RHHBY Quick Quote RHHBY - Free Report) for REGEN-COV outside the United States.
Given the alarming levels of the spread and severity of the pandemic, quite a few pharma/biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective enough to treat the infected patients. The emerging new strains pose a greater threat.
Vir Biotechnology, Inc. ( VIR Quick Quote VIR - Free Report) and partner GlaxoSmithKline plc ( GSK Quick Quote GSK - Free Report) submitted an application to the FDA requesting an EUA for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see
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