Iterum Therapeutics, plc
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It is alleged in this lawsuit that Iterum throughout the Class Period made misleading and/or false statements and/or failed to disclose that: (1) the sulopenem New Drug Application (“NDA”) lacked sufficient data that would support the approval of treatment of adult women with uncomplicated urinary tract infections (“uUTIs”) caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone; (2) it was unlikely that the U.S. Food and Drug Administration (“FDA”) would approve the sulopenem NDA in its current form, accordingly; (3) Iterum downplayed the severity of issues and deficiencies associated with the sulopenem NDA; and (4) Iterum’s public statements were materially false and misleading at all relevant times, as a result. This lawsuit claims that investors suffered damages, when the true details entered the market.