---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-117270"
form_type: "8-K"
ticker: "ITRMF"
cik: "0001659323"
company_name: "Iterum Therapeutics plc"
filed_at: "2024-10-25T23:59:59+00:00"
generated_at: "2026-05-30T10:04:05.354345+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Iterum receives FDA approval for ORLYNVAH for uUTIs; first product approval

## Summary
- FDA approved ORLYNVAH (oral sulopenem) for uUTIs in adult women with limited/no alternative oral antibiotics.
- Approval based on Phase 3 trials SURE 1 (superior to ciprofloxacin) and REASSURE (non-inferior to Augmentin, statistical superiority).
- ORLYNVAH is first oral penem approved in U.S. and Iterum's first FDA-approved product.
- Company renews efforts for strategic transaction (sale/partnership/license) involving ORLYNVAH to maximize value.
- Approximately 40M uUTI prescriptions annually in U.S.; ~1% resistant to all common oral antibiotics, addressing unmet need.

## SEC filing metadata
- accession: 0000950170-24-117270
- form_type: 8-K
- ticker: ITRMF
- cik: 0001659323
- company_name: Iterum Therapeutics plc
- filed_at: 2024-10-25T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1659323/000095017024117270/0000950170-24-117270-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1659323/000095017024117270/itrm-20241025.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-117270
- JSON: https://secwatch.observer/filing/0000950170-24-117270.json
- Plain text: https://secwatch.observer/filing/0000950170-24-117270.txt

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