---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-041338"
form_type: "8-K"
ticker: "FENC"
cik: "0001211583"
company_name: "FENNEC PHARMACEUTICALS INC."
filed_at: "2023-04-04T23:59:59+00:00"
generated_at: "2026-06-17T06:19:41.500865+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Fennec receives positive CHMP opinion for Pedmarqsi to prevent cisplatin-induced hearing loss in pediatric patients

## Summary
- CHMP recommends EU marketing authorization for Pedmarqsi (sodium thiosulfate) to prevent ototoxicity in pediatric patients aged 1 month to <18 years with localized solid tumors.
- Phase 3 trial SIOPEL 6 showed hearing loss in 28.6% with Pedmarqsi vs 56.4% with cisplatin alone (p=0.004).
- European Commission decision expected by early June 2023; Pedmarqsi is already FDA-approved as PEDMARK in the U.S.
- Approximately 5,000 children in Europe annually eligible for platinum-based chemotherapy could benefit from this therapy.

## SEC filing metadata
- accession: 0001104659-23-041338
- form_type: 8-K
- ticker: FENC
- cik: 0001211583
- company_name: FENNEC PHARMACEUTICALS INC.
- filed_at: 2023-04-04T23:59:59+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/1211583/000110465923041338/0001104659-23-041338-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1211583/000110465923041338/tm2311156d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-041338
- JSON: https://secwatch.observer/filing/0001104659-23-041338.json
- Plain text: https://secwatch.observer/filing/0001104659-23-041338.txt

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