---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-156074"
form_type: "8-K"
ticker: "GRTX"
cik: "0001563577"
company_name: "Galera Therapeutics, Inc."
filed_at: "2023-05-30T23:59:59+00:00"
generated_at: "2026-06-14T11:40:51.355621+00:00"
event_type: "litigation"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Galera Therapeutics sues CROs over Phase 3 ROMAN trial statistical error

## Summary
- Filed lawsuit in Pennsylvania against Alira Health Clinical and IQVIA Biotech for breach of contract and negligence.
- Error in 2021 statistical program for Phase 3 ROMAN trial corrected; yielded statistically significant p-values for primary and key secondary endpoints.
- Litigation is in early stages; company cannot predict outcome at this time.
- FDA accepted NDA for avasopasem with Priority Review; PDUFA target date August 9, 2023.

## SEC filing metadata
- accession: 0001193125-23-156074
- form_type: 8-K
- ticker: GRTX
- cik: 0001563577
- company_name: Galera Therapeutics, Inc.
- filed_at: 2023-05-30T23:59:59+00:00
- event_type: litigation
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1563577/000119312523156074/0001193125-23-156074-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1563577/000119312523156074/d465209d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-156074
- JSON: https://secwatch.observer/filing/0001193125-23-156074.json
- Plain text: https://secwatch.observer/filing/0001193125-23-156074.txt

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