---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-066932"
form_type: "8-K"
ticker: "ITRMF"
cik: "0001659323"
company_name: "Iterum Therapeutics plc"
filed_at: "2024-05-31T23:59:59+00:00"
generated_at: "2026-06-01T07:11:07.061260+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Iterum receives FDA acceptance of oral sulopenem NDA resubmission; PDUFA date Oct 25, 2024

## Summary
- FDA accepted resubmission of NDA for oral sulopenem for uUTIs in adult women; PDUFA action date set for October 25, 2024.
- Nasdaq granted 180-day extension until September 30, 2024 to regain compliance with minimum stockholders' equity requirement.
- CMO Sailaja Puttagunta steps down effective May 31, 2024; will serve as consultant at $400/hour during regulatory review.
- Resubmission includes REASSURE trial data showing oral sulopenem non-inferior to Augmentin and statistically superior for overall success.

## SEC filing metadata
- accession: 0000950170-24-066932
- form_type: 8-K
- ticker: ITRMF
- cik: 0001659323
- company_name: Iterum Therapeutics plc
- filed_at: 2024-05-31T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 5.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1659323/000095017024066932/0000950170-24-066932-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1659323/000095017024066932/itrm-20240529.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-066932
- JSON: https://secwatch.observer/filing/0000950170-24-066932.json
- Plain text: https://secwatch.observer/filing/0000950170-24-066932.txt

## Key facts
- Executive change
  Sailaja Puttagunta resigned as Chief Medical Officer at Iterum Therapeutics plc.
  - Action: resigned
  - Role: Chief Medical Officer
  source text: Dr. Puttagunta, whose previously announced resignation as CMO is effective as of May 31, 2024
  evidence_url: https://www.sec.gov/Archives/edgar/data/1659323/000095017024066932/0000950170-24-066932-index.htm

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