Shares of Iterum Therapeutics (NASDAQ:ITRM) 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.
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.
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.
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.