Iterum Therapeutics plc
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Northern District of Illinois on behalf of those who acquired Iterum Therapeutics plc (“Iterum” or the “Company”) (NASDAQ: ITRM) securities from November 30, 2020 through July 23, 2021, inclusive (the “Class Period”). Investors have until October 4, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Iterum is a clinical-stage pharmaceutical company that engages in developing anti-infectives for multi-drug resistant pathogens in Ireland and the United States. The Company is developing sulopenem, a novel anti-infective compound with oral and intravenous formulations that is in Phase III clinical trials for the treatment of, among other medical issues, uncomplicated urinary tract infections (“uUTIs”).
In November 2020, Iterum submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uUTIs in patients with a quinolone non-susceptible pathogen (the “sulopenem NDA”).
On July 1, 2021, Iterum issued a press release “announc[ing] that the Company received a letter from the [FDA] stating that, as part of their ongoing review of the [sulopenem 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 share price declined by $0.87 per share, or approximately 37.99%, from $2.29 per share 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 share price declined by $0.499 per share, or approximately 44.16%, from $1.13 per share to close at $0.631 per share on July 26, 2021.
The lawsuit alleges throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (i) the sulopenem New Drug Application (“NDA”) lacked sufficient data to support approval for the treatment of adult women with 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 securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at email@example.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.