Regeneron Pharmaceuticals Inc REGN faced a setback Friday in a trial evaluating its antibody cocktail REGN-COV2 in hospitalized COVID-19 patients.
What Happened: An independent data monitoring committee recommended that further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold, citing a potential safety signal and an unfavorable risk-benefit profile at this time, Regeneron said Friday.
The committee recommended continuing the enrollment of hospitalized patients who require either no or low-flow oxygen, stating that the risk-benefit remains acceptable in these cohorts.
The IDMC has sought modification in the hospitalized patient trial.
It also suggested that the outpatient trial can proceed without modification.
Why It's Important: Regeneron has an emergency use authorization application pending before the FDA for REGN-COV2 in mild-to-moderate coronavirus outpatients at high risk for poor outcomes.
Regeneron's COVID-19 pipeline shot to prominence after the investigational antibody cocktail was administered to President Donald Trump to treat his COVID-19 infection.
Eli Lilly And Co LLY had to halt its late-stage study of its antibody treatment candidate bamlanivimab in hospitalized severe COVID-19 patients.
REGN Price Action: At last check, Regeneron shares were slipping 2.49% to $541.97.
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