Skip to main content

Market Overview

FDA Requires Additional Data On Merck COVID-19 Drug, EUA Moved Back

  • 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.

Related Articles (MRK)

View Comments and Join the Discussion!

Posted-In: Covid-19Biotech News Health Care FDA General

Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
Everything you need to know about the latest SPAC news.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at