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Merck Will Apply for EUA of COVID-19 Antiviral in Wake of Promising Phase III Data

An interim analysis of data from 775 patients in the Phase III portion of the MOVe-OUT trial showed that 28 of 385 patients (7.3%) who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 53 of 377 patients (14.1%) treated with placebo. ....

Dainam Graybosch , Ridgeback Biotherapeutics , Robertm Davis , Michael Yee , Merck Co , Data Monitoring Committee , Managing Director ,

Merck to Seek FDA EUA for COVID-19 Pill after Positive Phase III Data

Merck & Co., said today it will pursue FDA emergency use authorization (EUA) “as soon as possible” for molnupiravir, the COVID-19 oral antiviral candidate it is developing with Ridgeback Biotherapeutics, following Phase III data showing an approximately 50% reduction in the risk of hospitalization or death in patients 29 days after treatment with the pill. ....

Dainam Graybosch , Ridgeback Biotherapeutics , Robertm Davis , Michael Yee , Merck Co , Data Monitoring Committee , Managing Director ,