---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-302295"
form_type: "8-K"
ticker: "GRTX"
cik: "0001563577"
company_name: "Galera Therapeutics, Inc."
filed_at: "2022-12-12T23:59:59+00:00"
generated_at: "2026-06-21T06:07:13.965948+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Galera submits NDA for avasopasem to reduce severe oral mucositis in head & neck cancer

## Summary
- NDA for avasopasem submitted to FDA for radiotherapy-induced severe oral mucositis (SOM) in head/neck cancer.
- Two positive placebo-controlled trials (Phase 3 ROMAN, Phase 2b GT-201) enrolled 678 patients total.
- ROMAN trial: statistically significant reduction in SOM incidence; median SOM days more than halved vs placebo.
- Prospectively defined analysis showed avasopasem reduced cisplatin-related chronic kidney disease by 50%.
- FDA previously granted Fast Track and Breakthrough Therapy designations; no approved SOM drug currently exists.

## SEC filing metadata
- accession: 0001193125-22-302295
- form_type: 8-K
- ticker: GRTX
- cik: 0001563577
- company_name: Galera Therapeutics, Inc.
- filed_at: 2022-12-12T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1563577/000119312522302295/0001193125-22-302295-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1563577/000119312522302295/d371259d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-302295
- JSON: https://secwatch.observer/filing/0001193125-22-302295.json
- Plain text: https://secwatch.observer/filing/0001193125-22-302295.txt

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