Robbins Geller Rudman & Dowd LLP announces that purchasers of Iterum Therapeutics plc (NASDAQ: ITRM) securities between November 30, 2020 and July 23, 2021, inclusive (“Class Period”) have until October 4, 2021 to seek appointment as lead plaintiff in the Iterum class action lawsuit. The Iterum class action lawsuit charges Iterum and certain of its top executives with violations of the Securities Exchange Act of 1934. The Iterum class action lawsuit was commenced on August 5, 2021 in the Northern District of Illinois and is captioned Klein v. Iterum Therapeutics plc, No. 21-cv-04181.

If you wish to serve as lead plaintiff of the Iterum class action lawsuit, please provide your information by clicking here. You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at jsanchez@rgrdlaw.com. Lead plaintiff motions for the Iterum class action lawsuit must be filed with the court no later than October 4, 2021.

CASE ALLEGATIONS: Iterum is a pharmaceutical company developing sulopenem, an 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 Iterum class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and 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, Iterum’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 nearly 38%.

Then, on July 26, 2021, Iterum issued a press release announcing that it had received a Complete Response Letter (“CRL”) 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 an additional 44%, further damaging investors.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Iterum securities during the Class Period to seek appointment as lead plaintiff in the Iterum class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Iterum class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Iterum class action lawsuit. An investor’s ability to share in any potential future recovery of the Iterum class action lawsuit is not dependent upon serving as lead plaintiff.

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: With 200 lawyers in 9 offices nationwide, Robbins Geller Rudman & Dowd LLP is the largest U.S. law firm representing investors in securities class actions. Robbins Geller attorneys have obtained many of the largest shareholder recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig. The 2020 ISS Securities Class Action Services Top 50 Report ranked Robbins Geller first for recovering $1.6 billion for investors last year, more than double the amount recovered by any other securities plaintiffs’ firm. Please visit https://www.rgrdlaw.com/firm.html for more information.

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