---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-026878"
form_type: "8-K"
ticker: "ITRMF"
cik: "0001659323"
company_name: "Iterum Therapeutics plc"
filed_at: "2024-03-06T23:59:59+00:00"
generated_at: "2026-06-05T02:42:57.345460+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Iterum expects NDA resubmission for oral sulopenem in Q2 2024; cash runway into 2025

## Summary
- NDA resubmission for oral sulopenem to FDA expected in first half of Q2 2024, earlier than originally planned.
- FDA action expected six months after resubmission (first half of Q4 2024), assuming deficiencies addressed.
- Cash and equivalents as of Dec 31, 2023 plus ATM proceeds through Feb 29, 2024 expected to fund ops into 2025, including through PDUFA date.
- Company plans to engage financial advisor to assist with strategic alternatives (sale, license, or disposal of rights to sulopenem).

## SEC filing metadata
- accession: 0000950170-24-026878
- form_type: 8-K
- ticker: ITRMF
- cik: 0001659323
- company_name: Iterum Therapeutics plc
- filed_at: 2024-03-06T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1659323/000095017024026878/0000950170-24-026878-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1659323/000095017024026878/itrm-20240306.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-026878
- JSON: https://secwatch.observer/filing/0000950170-24-026878.json
- Plain text: https://secwatch.observer/filing/0000950170-24-026878.txt

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