Iterum completes enrollment in Phase 3 uUTI trial; topline data expected early Q1 2024

Iterum Therapeutics plc

Completed enrollment in REASSURE trial of oral sulopenem vs Augmentin in uncomplicated UTIs ahead of schedule.
Topline data expected early Q1 2024; NDA resubmission planned for Q2 2024 subject to data analysis.
FDA review expected within 6 months of resubmission, with action anticipated in H2 2024, if deficiencies addressed.
Sulopenem is a novel oral penem; company notes it could be first new uUTI antibiotic approved in over 25 years.

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