Regeneron says IDMC recommends halt of some REGN-COV2 trial enrollment for safety risks

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Shares of Regeneron Pharmaceuticals Inc. slumped 1.2% in morning trading Friday, after the biotechnology company said an independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 recommended that the patient trial be “modified,” with the enrollment of some patients place on hold. REGN-COV2 was one of the treatments prescribed to President Trump after he tested positive for COVID-19. Based on a “potential safety signal and an unfavorable risk/benefit profile at this time,” the IDMC recommended that further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending analysis of further data. The IDMC also recommends continuing enrollment of patients requiring no or low-flow oxygen and the continuation of the outpatient trial without modification. REGN-COV2 is currently being evaluated by the Food and Drug Administration for a potential Emergency Use Authorization in mild-to-moderate outpatients with high risk of poor outcomes. The stock has lost 13% over the past three months, while the S&P 500 has gained 1.6%.
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