secwatch.observer — SEC 8-K summary
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Issuer:     Iterum Therapeutics plc (ITRMF)
CIK:        0001659323
Form:       8-K
Filed at:   2023-10-24T23:59:59+00:00
Accession:  0000950170-23-054714
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Iterum completes enrollment in Phase 3 uUTI trial; topline data expected early Q1 2024
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- Completed enrollment in REASSURE trial of oral sulopenem vs Augmentin in uncomplicated UTIs ahead of schedule.
- Topline data expected early Q1 2024; NDA resubmission planned for Q2 2024 subject to data analysis.
- FDA review expected within 6 months of resubmission, with action anticipated in H2 2024, if deficiencies addressed.
- Sulopenem is a novel oral penem; company notes it could be first new uUTI antibiotic approved in over 25 years.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1659323/000095017023054714/0000950170-23-054714-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1659323/000095017023054714/itrm-20231024.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-054714

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