---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-068593"
form_type: "8-K"
ticker: "FENC"
cik: "0001211583"
company_name: "FENNEC PHARMACEUTICALS INC."
filed_at: "2023-06-07T23:59:59+00:00"
generated_at: "2026-06-14T05:39:57.728696+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Fennec gets EU approval for Pedmarqsi to prevent cisplatin-induced hearing loss in children

## Summary
- European Commission granted marketing authorization for Pedmarqsi (sodium thiosulfate) for pediatric localized solid tumors.
- First and only approved therapy in EU for preventing cisplatin-induced ototoxicity; includes 8+2 years data/market protection.
- Approval based on Phase 3 trials SIOPEL 6 and COG ACCL0431; applies to all 27 EU states plus Iceland, Norway, Liechtenstein.
- PEDMARK already FDA-approved in U.S. since September 2022; Fennec expects to make Pedmarqsi available in EU soon.

## SEC filing metadata
- accession: 0001104659-23-068593
- form_type: 8-K
- ticker: FENC
- cik: 0001211583
- company_name: FENNEC PHARMACEUTICALS INC.
- filed_at: 2023-06-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1211583/000110465923068593/0001104659-23-068593-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1211583/000110465923068593/tm2317930d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-068593
- JSON: https://secwatch.observer/filing/0001104659-23-068593.json
- Plain text: https://secwatch.observer/filing/0001104659-23-068593.txt

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