The FDA decision on Iterum Therapeutics plc’s (ITRM) lead drug candidate oral Sulopenem is expected on July 25.The company’s oral Sulopenem is proposed for the treatment of uncomplicated urinary tract infections (uUTI) in patients with quinolone non-susceptible pathogens.Sulopenem, a penem antibiotic, available in oral and IV formulations, was licensed from Pfizer by Iterum in November 2015.If approved, oral Sulopenem has a revenue opportunity of roughly $500 million in the quinolone non-susceptible uUTI indication, according to the company.ITRM closed Wednesday’s (Jun.23, 2021) trading at $2.01, down 0.5%.