secwatch.observer — SEC 8-K summary
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Issuer:     Iterum Therapeutics plc (ITRMF)
CIK:        0001659323
Form:       8-K
Filed at:   2024-04-29T23:59:59+00:00
Accession:  0000950170-24-049928
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Iterum resubmits NDA for oral sulopenem to FDA for uUTIs; potential approval early Q4 2024
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- Resubmitted NDA on April 29, 2024, for oral sulopenem (sulopenem etzadroxil/probenecid) for uncomplicated UTIs in adult women.
- REASSURE trial showed oral sulopenem non-inferior and statistically superior to Augmentin in uUTI patients with susceptible pathogens.
- SURE 1 trial demonstrated statistical superiority of oral sulopenem vs ciprofloxacin in patients with quinolone non-susceptible pathogens.
- FDA review expected to complete six months from receipt; potential approval early Q4 2024, addressing July 2021 CRL deficiencies.
- If approved, would be first oral penem in the U.S. and second new oral uUTI treatment in over 25 years.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1659323/000095017024049928/0000950170-24-049928-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1659323/000095017024049928/itrm-20240429.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-049928

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