A lawsuit was filed on behalf of investors in Iterum Therapeutics plc (NASDAQ:ITRM) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 09/21/2021 -- An investor, who purchased NASDAQ: ITRM shares, filed a lawsuit against Iterum Therapeutics plc over alleged Securities Laws violations.
Investors who purchased shares of Iterum Therapeutics plc (NASDAQ: ITRM) have certain options and for certain investors are short and strict deadlines running. Deadline: October 4, 2021. NASDAQ: ITRM investors should contact the Shareholders Foundation at firstname.lastname@example.org or call +1(858) 779 - 1554.
Ireland based Iterum Therapeutics plc, a clinical-stage pharmaceutical company, engages in developing anti-infectives for multi-drug resistant pathogens in Ireland and the United States. In November 2020, Iterum Therapeutics plc 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 Therapeutics plc 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."
Shares of Iterum Therapeutics plc (NASDAQ: ITRM) declined from $2.13 per share on June 24, 2021, to $0.63 per share on July 26, 2021.
The plaintiff claims that between November 30, 2020 and July 23, 2021, the Defendants made false and/or misleading statements and/or failed to disclose that 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, that accordingly, it was unlikely that the FDA would approve the sulopenem NDA in its current form, that Defendants downplayed the severity of issues and deficiencies associated with the sulopenem NDA, and that as a result, the Company's public statements were materially false and misleading at all relevant times.
Those who purchased shares of Iterum Therapeutics plc (NASDAQ: ITRM) have certain options and should contact the Shareholders Foundation.
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