ITRM - Why Iterum Therapeutics Stock Is Trending Today | Benzinga
Iterum Therapeutics PLC (NASDAQ:ITRM) shares are trending Tuesday after the company announced its Phase 3 Reassure trial met the primary endpoint of non-inferiority to Augmentin.
The Details:
Iterum Therapeutics announced positive topline results from its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) Phase 3 clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin.
“We are very pleased to announce positive data from this confirmatory trial, which was conducted under special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA),” said Corey Fishman, Iterum’s CEO.
“With the positive data from this trial, we plan to resubmit our New Drug Application (NDA) for oral sulopenem for the treatment of uUTI in the second quarter of 2024. At the same time, with ...