Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Iterum Therapeutics plc (“Iterum” or the “Company”) (Nasdaq: ITRM) in the United States District Court for the Northern District of Illinois on behalf of all persons and entities who purchased or otherwise acquired Iterum securities between November 30, 2020 and July 23, 2021, both dates inclusive (the “Class Period”). Investors have until October 4, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Click here to participate in the action.

On July 1, 2021, Iterum issued a press release “announc[ing] that the Company received a letter from the [U.S. Food and Drug Administration (“FDA”)] stating that, as part of their ongoing review of the [sulopenem New Drug Application “NDA”], the agency has identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time.”

On this news, Iterum’s ordinary share price fell $0.87 per share, or 37.99%, to close at $1.42 per share on July 2, 2021.

Then, on July 26, 2021, Iterum issued a press release announcing that it had received a Complete Response Letter from the FDA for the sulopenem NDA, “provid[ing] that the FDA has completed its review of the NDA and has determined that it cannot approve the NDA in its present form.”

On this news, Iterum’s ordinary share price fell $0.499 per share, or 44.16%, to close at $0.631 per share on July 26, 2021.

The complaint alleges that, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (i) the sulopenem (“NDA”) lacked sufficient data to support approval for the treatment of adult women with uncomplicated urinary tract infections (“uUTIs”) caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone; (ii) accordingly, it was unlikely that the FDA would approve the sulopenem NDA in its current form; (iii) defendants downplayed the severity of issued and deficiencies associated with the sulopenem NDA; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.

If you purchased or otherwise acquired Iterum shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

About Bragar Eagel & Squire, P.C.:

Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

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