Iterum Therapeutics plc
Exchange: NASDAQ
Ticker: ITRM
Date of Filing: 08/05/2021
Court: Illinois Northern District Court
Filing Deadline

10/04/2021

Iterum Therapeutics plc

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”). The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, 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 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 issues 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. 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.” The press release further stated that “[n]o details with respect to deficiencies were disclosed by the FDA in this notification and the letter further states that the notification does not reflect a final decision on the information under review.” 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.” Specifically, “the FDA determined that additional data are necessary 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[,]” while “recommend[ing] that Iterum conduct at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug[,]” and “conduct further nonclinical investigation to determine the optimal dosing regimen . . . .” 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.


For More information  as well as to join this case please contact Atara Twersky, Esq. at [email protected] or [email protected].  Atara is Principal at Twersky Law Group and Of counsel at AF&T law firm where she is director of Investor Services.  Atara focuses her practice on assisting her clients with increasing their investment portfolio recoveries and ensuring that their portfolios remain healthy and robust.  For more information on shareholder recoveries click here and to listen to Atara’s podcast with notable guests in the Pension fund Industry listen to Pension and Investments Podcast, on all matters related to your investment portfolio and more. For more information on  Atara and her legal work connected to shareholder protection click here

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COMPLAINT

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