Item 8.01. Other Events.

On May 27, 2021, Iterum Therapeutics plc (the "Company") issued a press release announcing that on May 26, 2021 the Company participated in a late-cycle meeting with the U.S. Food and Drug Administration ("FDA") during which, the FDA shared, and the Company responded to, issues still under review regarding the Company's new drug application ("NDA") for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen. The FDA has determined that an Advisory Committee meeting is not currently necessary. The review of the NDA is ongoing and the Company was informed that the FDA continues to work toward the PDUFA goal date of July 25, 2021

The full text of the press release issued in connection with this announcement is attached as Exhibit 99.1 to this Current Report of Form 8-K and incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.



(d) Exhibits.




  Exhibit No.   Description

    99.1          Press Release of Iterum Therapeutics plc dated May 27, 2021

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses