Iterum Therapeutics to Host Morning Conference Call on U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections

Core Points - Iterum Therapeutics plc has received FDA approval for ORLYNVAH™ (Oral Sulopenem) to treat uncomplicated urinary tract infections (uUTIs) [2][4] - ORLYNVAH™ is the first oral penem approved in the U.S. and the first FDA-approved product for Iterum [2] - The approval addresses uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial options [2][4] Company Overview - Iterum Therapeutics focuses on developing differentiated anti-infectives to combat multi-drug resistant pathogens [1][4] - The company is advancing sulopenem, a novel penem anti-infective compound, available in both oral and IV formulations [4] - Sulopenem has shown potent in vitro activity against various resistant bacteria, and Iterum has received QIDP and Fast Track designations for its formulations in seven indications [4]