Iterum resubmits NDA for oral sulopenem to FDA for uUTIs; potential approval early Q4 2024

Iterum Therapeutics plc

Resubmitted NDA on April 29, 2024, for oral sulopenem (sulopenem etzadroxil/probenecid) for uncomplicated UTIs in adult women.
REASSURE trial showed oral sulopenem non-inferior and statistically superior to Augmentin in uUTI patients with susceptible pathogens.
SURE 1 trial demonstrated statistical superiority of oral sulopenem vs ciprofloxacin in patients with quinolone non-susceptible pathogens.
FDA review expected to complete six months from receipt; potential approval early Q4 2024, addressing July 2021 CRL deficiencies.
If approved, would be first oral penem in the U.S. and second new oral uUTI treatment in over 25 years.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.