FDA Requires Additional Data On Merck COVID-19 Drug, EUA Moved Back - Merck & Co (NYSE:MRK)

Merck & Co Inc (NYSE: MRK) had reported a significant snag in its latest annual filing (10K), wherein the company has received feedback from the FDA regarding its COVID-19 drug, MK-7110.
The agency has asked for additional data beyond the study conducted by OncoImmune to support a potential emergency use application.
Hence following the feedback, Merck no longer expects to supply the U.S. government with MK-7110 in the first half of 2021.
OncoImmune reported top-line findings from an interim efficacy analysis of Phase 3 study of 203 participants.
Data showed that hospitalized patients with COVID-19 treated with a single dose of MK-7110 showed a 60% higher probability of improvement in clinical status than placebo.
The risk of death or respiratory failure was reduced by more than 50%.
Merck has already ditched a vaccine program for COVID-19 after early trials showed both vaccines generated inferior immune responses in people who had recovered from COVID-19 as well as those reported for other COVID-19 vaccines.
The company said it is “actively working with FDA to address the agency’s comments.”
Merck spent $425 million to buy OncoImmune and the drug last year November.
See 10K here.
Price Action: MRK is trading 1.72% at $73.33 in market trading hours on the last check Friday.