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

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Oct 28, 2024

PR Newswire

Monday, October 28, 2024, at 8:30 a.m. EDT

DUBLIN and CHICAGO, Oct. 28, 2024 /PRNewswire/ --

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WHO:

Iterum Therapeutics plc (Nasdaq: ITRM) is focused on delivering
differentiated anti-infectives aimed at combatting the global crisis of multi-drug
resistant pathogens to significantly improve the lives of people affected by
serious and life-threatening diseases around the world.

WHAT:

Conference call to discuss U.S. Food and Drug Administration (FDA) approval of
Iterum's ORLYNVAHâ„¢ (Oral Sulopenem) for the treatment of uncomplicated
urinary tract infections (uUTIs).

Speakers include: Corey Fishman (CEO) and Steve Aronin (Senior Vice
President and Head of Clinical Development

WHY:

ORLYNVAHâ„¢ (sulopenem etzadroxil and probenecid) is the first oral penem
approved for use in the U.S. and the first FDA-approved product for Iterum.
ORLYNVAHâ„¢ is approved for the treatment of uUTIs caused by the designated
microorganisms Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis in
adult women who have limited or no alternative oral antibacterial treatment
options. It is only the second FDA-approved treatment for uUTIs in the past two
decades.

For more details, view the press release issued Friday here.

WHEN:

Monday, October 28, 2024
8:30 a.m. Eastern Daylight Time

Dial-in information:
United States: +1 833-470-1428 | International: +1 404-975-4839
Access code: 936149

The conference call replay will be available in the Events & Presentations page of Iterum's website following the call.

About Iterum Therapeutics plc
Iterum Therapeutics plc is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received approval of its NDA for ORLYNVAHâ„¢ (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the U.S. Food and Drug Administration and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit www.iterumtx.com.

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SOURCE Iterum Therapeutics plc

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