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

    10/28/24 5:00:00 AM ET
    $ITRM
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $ITRM alert in real time by email

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

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

    Iterum Therapeutics Logo

    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 ORLYNVAH™ (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:

    ORLYNVAH™ (sulopenem etzadroxil and probenecid) is the first oral penem

    approved for use in the U.S. and the first FDA-approved product for Iterum.

    ORLYNVAH™ 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 ORLYNVAH™ (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.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/iterum-therapeutics-to-host-morning-conference-call-on-us-fda-approval-of-orlynvah-oral-sulopenem-for-the-treatment-of-uncomplicated-urinary-tract-infections-302288057.html

    SOURCE Iterum Therapeutics plc

    Get the next $ITRM alert in real time by email

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    Save time and jump to the most important pieces.

    Q&A

    New
    • What is the focus of Iterum Therapeutics plc?

      Iterum Therapeutics plc is a biopharmaceutical company focused on developing differentiated anti-infectives to combat multi-drug resistant pathogens and improve the lives of patients with serious diseases.

    • What will be the main topic of the conference call hosted by Iterum Therapeutics?

      The conference call will discuss the FDA approval of Iterum's ORLYNVAH™ (Oral Sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs).

    • What is ORLYNVAH™ and what is it approved for?

      ORLYNVAH™ (sulopenem etzadroxil and probenecid) is the first oral penem approved in the U.S. and is specifically for uUTIs caused by bacteria such as Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in women with limited treatment options.

    • When is the conference call for discussing the FDA approval of ORLYNVAH™?

      The conference call is scheduled for Monday, October 28, 2024, at 8:30 a.m. Eastern Daylight Time.

    • What are the dial-in details for the conference call?

      The dial-in information for the conference call includes the United States number +1 833-470-1428 and the International number +1 404-975-4839, with an access code of 936149.

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