Iterum Therapeutics reports Q4 EPS (81c) vs. (52c) last year

“Since we announced positive topline data from our REASSURE trial in January, we’ve made significant progress in completing the new drug application for the planned resubmission early in the second quarter,” said Corey Fishman, Iterum’s Chief Executive Officer. “We believe the strong results from this trial, which was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration, address the FDA’s recommendations for additional data to support approval of oral sulopenem for the treatment of adult women with uncomplicated urinary tract infections. The potential approval of sulopenem would mark the first oral penem approved in the U.S., and the first antibiotic approved for the treatment of uUTIs in over 25 years.”