---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-075885"
form_type: "8-K"
ticker: "ITRMF"
cik: "0001659323"
company_name: "Iterum Therapeutics plc"
filed_at: "2024-06-21T23:59:59+00:00"
generated_at: "2026-06-01T02:52:26.604165+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Iterum Therapeutics gets FDA Advisory Committee meeting on Sept 9, 2024 for oral sulopenem NDA for uUTI

## Summary
- FDA Advisory Committee to discuss NDA for oral sulopenem (first oral penem in U.S.) for uUTI in adult women; proposed date September 9, 2024.
- Discussion topics: antimicrobial stewardship issues and appropriate target patient population.
- PDUFA action date set at October 25, 2024 for Class II resubmission.

## SEC filing metadata
- accession: 0000950170-24-075885
- form_type: 8-K
- ticker: ITRMF
- cik: 0001659323
- company_name: Iterum Therapeutics plc
- filed_at: 2024-06-21T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 5.07, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1659323/000095017024075885/0000950170-24-075885-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1659323/000095017024075885/itrm-20240619.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-075885
- JSON: https://secwatch.observer/filing/0000950170-24-075885.json
- Plain text: https://secwatch.observer/filing/0000950170-24-075885.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.