Pomerantz Law Firm Announces the Filing of a Class Action

NEW YORK, Aug 21, 2021 (GLOBE NEWSWIRE) – Pomerantz LLP announces that a class action lawsuit has been filed against Iterum Therapeutics plc (“Iterum” or the “Company”) (NASDAQ: ITRM) and some of its officers. The class action lawsuit, filed in the United States District Court for the Northern District of Illinois, Eastern Division, filed at 21-cv-04181, is on behalf of a group consisting of all persons and entities other than the defendants who purchased or otherwise acquired Iterum Securities between November 30, 2020 and July 23, 2021, both days inclusive (the “Accumulation Period”), to compensate for any damage caused by Defendant’s breach of federal securities laws and to seek legal redress under Sections 10 (b) and 20. Pursue (a) the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 under it against the Company and some of its senior officials.

If you are a shareholder who purchased or otherwise acquired Iterum securities during the class action period, you have until October 4, 2021 to request the court to appoint you as the lead plaintiff for the class action. A copy of the complaint is available at www.pomerantzlaw.com. To discuss this promotion, contact Robert S. Willoughby at newaction@pomlaw.com or 888.476.6529 (or 888.4-POMLAW) toll free ext. 7980. Inquiries by email are encouraged to include their postal address, telephone number, and the number of shares purchased.

[Click here for information about joining the class action]

Iterum is a clinical stage pharmaceutical company developing anti-infectives for multi-drug drug resistance in Ireland and the United States. The company is developing Sulopenem, a novel anti-infective agent with oral and intravenous formulations that is in phase III clinical trials for the treatment of uncomplicated urinary tract infections (“uUTIs”), among other things.

In November 2020, Iterum submitted an application to the US Food and Drug Administration (FDA) for a new drug (“NDA”) for sulopenemetzadroxil / probenecid (oral sulopenem) for the treatment of urinary tract infections in patients with a pathogen that is not sensitive to quinolone (the “Sulopenem NDA”).

The lawsuit alleges that during the class action period the defendants made essentially false and misleading statements about the company’s business, operational and compliance policies. In particular, Defendants made false and / or misleading statements and / or did not disclose that: (i) the sulopenem NDA did not have sufficient data to support approval for the treatment of adult women with uUTIs caused by identified susceptible microorganisms who have been shown 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 have downplayed the severity 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] declares 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 in time. ”The press release continues:“[n]o Details of 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.

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 determined that it cannot approve the NDA in its current form. “In particular,” the FDA has determined that additional data is required in order to obtain approval for the treatment of adult women with [uUTIs] caused by identified susceptible microorganisms that have been shown to be or are strongly suspected of being sensitive to a quinolone[,]”While” recommend “[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.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris and Tel Aviv, is one of the leading law firms in corporate, securities and antitrust litigation. Founded by the late Abraham L. Pomerantz, best known as the Dean of the Class Action Chamber, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues the tradition he founded and fights for the rights of victims of securities fraud, breaches of duty of loyalty and corporate misconduct. The company has collected numerous millions of dollars in damages on behalf of class members. See www.pomlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 7980