“We are pleased to have recently resubmitted our new drug application for oral sulopenem just three months after reporting positive topline data from our REASSURE trial in January 2024,” said Corey Fishman, Iterum’s Chief Executive Officer. “We continue to believe that the strong results from this trial, which was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration, addresses the FDA’s recommendations for additional data to support approval of oral sulopenem for the treatment of adult women with uncomplicated urinary tract infections. The potential approval of oral sulopenem would mark the first oral penem approved in the U.S., and the second antibiotic approved for the treatment of uUTIs over the past 25 years.”
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on ITRM:
- Iterum Therapeutics Announces CMO Transition and Consultant Role
- Iterum Therapeutics resubmits NDA to U.S. FDA for oral sulopenem
- Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem
- Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results
- Iterum Therapeutics sees cash runway into 2025