Iterum Therapeutics plc announced the completion of patient enrollment in its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI). Iterum expects to report topline data early in the first quarter of 2024 and, subject to its analysis of the data, to resubmit its New Drug Application (NDA) for oral sulopenem for the treatment of uUTIs to the U.S. Food and Drug Administration (FDA) in the second quarter of 2024. Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter Iterum received from the FDA in July 2021, Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA (or during the second half of 2024).