Iterum Therapeutics Announces FDA To Review New Drug Application For Oral Sulopenem Etzadroxil/Probenecid For Uncomplicated UTIs In Advisory Committee Meeting On September 9, 2024; Discussion To Focus On Antimicrobial Stewardship And Target Patient Population
Portfolio Pulse from Benzinga Newsdesk
Iterum Therapeutics announced that the FDA will review its New Drug Application for oral sulopenem etzadroxil/probenecid for uncomplicated UTIs in an advisory committee meeting on September 9, 2024. The discussion will focus on antimicrobial stewardship and the target patient population.
June 21, 2024 | 12:02 pm
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
Iterum Therapeutics' New Drug Application for oral sulopenem etzadroxil/probenecid will be reviewed by the FDA on September 9, 2024. The review will focus on antimicrobial stewardship and the target patient population.
The FDA's review of Iterum Therapeutics' NDA is a significant regulatory event that could lead to approval and commercialization of the drug, potentially boosting the company's stock price. The focus on antimicrobial stewardship and target patient population indicates a thorough review process.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100