Please ensure Javascript is enabled for purposes of website accessibility

Why Iterum Therapeutics Stock Soared Today

By Keith Speights - May 28, 2021 at 3:54PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The FDA gave the company some good news.

What happened

Shares of Iterum Therapeutics (ITRM 4.04%) were soaring 18.3% higher as of 3:40 p.m. EDT on Friday. The big gain came after the company announced that the U.S. Food and Drug Administration (FDA) wouldn't require an advisory committee review of the regulatory filing for sulopenem etzadroxil/probenecid in treating urinary tract infections.

So what

Iterum submitted its filing in January of this year. The FDA originally planned to convene an advisory committee to review the application on June 2, 2021. This meeting was pushed back, though, to give the agency more time to review Iterum's data.

A person wearing a coat and tie holding yellow blocks with red letters spelling FDA.

Image source: Getty Images.

The company met with the FDA on Thursday to review issues that were still under review with its filing. Iterum responded to these issues and learned of the agency's decision to scrap plans to require an advisory committee review. This decision is good news for Iterum because it's one less hurdle for sulopenem etzadroxil/probenecid to jump before potentially winning FDA approval.

Now what

Another major catalyst for the biotech stock could be on the way soon. The FDA is scheduled to announce its decision on approval of sulopenem etzadroxil/probenecid by July 25.

Keith Speights has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Iterum Therapeutics plc Stock Quote
Iterum Therapeutics plc
$0.26 (4.04%) $0.01

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
S&P 500 Returns

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 08/15/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.