Iterum Therapeutics plc (ITRM) Made Misleading Statements Regarding its Drug Candidate
Iterum is developing sulopenem, an anti-infective compound with oral and intravenous formulations that is in Phase III clinical trials for the treatment of 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. During the relevant period, the Company touted the efficacy and viability of the drug.
On July 1, 2021, Iterum announced it had “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.” On this news, Iterum’s share price fell $0.87 per share, or almost 40%, to close at $1.42 per share on July 2, 2021. Then, on July 26, 2021, Iterum announced it had received a Complete Response Letter from the FDA indicating that the FDA had completed its review of the NDA and cannot approve it in its present form. 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.” The FDA recommended ”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, the stock price fell further, to close at just $0.63 per share on July 26, 2021, and has yet to recover.
If you purchased shares of Iterum Therapeutics plc (ITRM) between November 30, 2020 and July 23, 2021, you have until October 4, 2021, to ask the court to appoint you lead plaintiff for the class.
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