Gainey McKenna & Egleston Announces A Class Action Lawsuit Has Been Filed Against Iterum Therapeutics plc (ITRM)

NEW YORK, Aug 9, 2021 (GLOBE NEWSWIRE) – Gainey McKenna & Egleston announce that a US class action lawsuit has been filed against Iterum Therapeutics plc (“Iterum” or the “Company”) (NASDAQ: ITRM) District Court for the Northern District of Illinois, Eastern Division, on behalf of those who purchased or otherwise acquired publicly traded securities of Iterum between November 30, 2020 and July 23, 2021 (the “Collection Period”).

The lawsuit alleges that during the class action period, defendants made essentially false and misleading statements about the company’s business, operational, and compliance policies. In particular, the lawsuit alleges that defendants have made false and / or misleading statements and / or failed to disclose that: (i) the sulopenem NDA did not provide sufficient data to support approval for the treatment of adult women with urinary tract infections caused by susceptible microorganisms have been caused, demonstrated or strongly suspected that it is not susceptible to a quinolone; (ii) accordingly, it was unlikely that the FDA would approve the sulopenem NDA in its current form; (iii) Defendants have downplayed the gravity of the problems and deficiencies related to the sulopenem NDA; and (iv) as a result, the Company’s public statements at all relevant times have been materially false and misleading.

On July 1, 2021, Iterum published a press release “announce”[ing] that the company received a letter from the [FDA] stated that as part of their ongoing review of the [sulopenem NDA], the agency has identified deficiencies that preclude the discussion of labeling and post-marketing requirements / obligations from continuing at this point. “The press release goes on to say:”[n]o Details of the deficiencies were disclosed by the FDA in this notice, and the letter goes on to state that the notice does not reflect a final decision on the information to be reviewed. “

In light of the news, Iterum’s common stock price fell $ 0.87 per share, or 37.99%, to close at $ 1.42 per share on July 2, 2021.

The story goes on

Then, on July 26, 2021, Iterum issued a press release announcing that it had received a full response letter from the FDA for the sulopenem NDA, “Provided[ing] that the FDA has completed its review of the NDA and has determined that it cannot approve the NDA in its current form. In particular, the FDA has determined that additional data are required in order to obtain approval for the treatment of adult women with [uUTIs] caused by identified susceptible microorganisms that can be shown or urgently suspected that they are not sensitive to a quinolone[,]Recommend “during”[ing] that Iterum will conduct at least one additional appropriate and well-controlled clinical study, possibly with a different comparator drug[,]”and” conduct additional non-clinical investigations to determine the optimal dosage regimen. . . . “

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

Investors who have purchased or otherwise acquired shares in Iterum during the Class Action Period should contact the Company before October 4, 2021 Lead plaintiff’s deadline for filing. A lead plaintiff is a representative party who acts on behalf of other group members in directing the dispute. If you would like to discuss your rights or interests in relation to this class action lawsuit, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. from Gainey McKenna & Egleston at (212) 983-1300 or by email at [email protected] or [email protected].

Please visit our website at http://www.gme-law.com for more information on the firm.

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