Why Regeneron Is Halting Coronavirus Antibody Cocktail Study Enrollment In Patients With Severe Cases

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.

Related Link: The Daily Biotech Pulse: Novavax Vaccine Data, Axovant Flags Delay In Parkinson's Study, 2 Biotechs Make Wall Street Debuts

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. 

Related Link: The Week Ahead In Biotech: Kala FDA Decision, Merck & Pfizer Earnings, Vaccine Updates And IPOs