---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-039798"
form_type: "8-K"
ticker: "GRTX"
cik: "0001563577"
company_name: "Galera Therapeutics, Inc."
filed_at: "2023-02-15T23:59:59+00:00"
generated_at: "2026-06-19T11:20:21.485320+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Galera Therapeutics announces FDA priority review of NDA for avasopasem in SOM; PDUFA date Aug 9, 2023

## Summary
- FDA accepted NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis in head/neck cancer.
- Priority review assigned; PDUFA target action date of August 9, 2023; no advisory committee meeting planned.
- Company estimates total US market opportunity for SOM exceeds $1 billion.
- Preliminary cash and investments balance of ~$31.6M as of Dec 31, 2022; audited results pending.

## SEC filing metadata
- accession: 0001193125-23-039798
- form_type: 8-K
- ticker: GRTX
- cik: 0001563577
- company_name: Galera Therapeutics, Inc.
- filed_at: 2023-02-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1563577/000119312523039798/0001193125-23-039798-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1563577/000119312523039798/d419811d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-039798
- JSON: https://secwatch.observer/filing/0001193125-23-039798.json
- Plain text: https://secwatch.observer/filing/0001193125-23-039798.txt

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