Iterum Therapeutics reports Q3 EPS (30c) vs ($2.38) last year

Reports Q3 revenue $, consensus $. “Last month, we completed the enrollment of 2,229 patients in our REASSURE trial in a 12-month period and expect to report top-line data early in the first quarter of 2024,” said Corey Fishman, Iterum’s Chief Executive Officer. “Subject to our analysis of the data, we plan to resubmit our NDA for the treatment of uncomplicated urinary tract infections in the second quarter of 2024 and expect the FDA to have completed its review of the NDA in the fourth quarter of 2024. If approved, oral sulopenem will be the first oral penem available in the United States and the first treatment approved in the U.S. for uUTI since the turn of the century.”