---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-22-109063"
form_type: "8-K"
ticker: "FENC"
cik: "0001211583"
company_name: "FENNEC PHARMACEUTICALS INC."
filed_at: "2022-10-17T23:59:59+00:00"
generated_at: "2026-06-23T03:12:48.456431+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Fennec launches PEDMARK in US for cisplatin-induced hearing loss in pediatric patients

## Summary
- PEDMARK is the first and only FDA-approved therapy to reduce cisplatin-induced ototoxicity in pediatric patients aged 1 month+ with localized solid tumors.
- Launch follows FDA approval in September 2022; based on Phase 3 trials COG ACCL0431 and SIOPEL 6.
- Annual estimated 10,000+ US/European children receive platinum chemo; ~60% may develop permanent hearing loss without PEDMARK.
- Fennec HEARS program launched to provide patient financial support, access coordinators, and prescription drug assistance.
- EMA is currently evaluating Marketing Authorization Application for PEDMARQSI (sodium thiosulfate) in Europe.

## SEC filing metadata
- accession: 0001104659-22-109063
- form_type: 8-K
- ticker: FENC
- cik: 0001211583
- company_name: FENNEC PHARMACEUTICALS INC.
- filed_at: 2022-10-17T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1211583/000110465922109063/0001104659-22-109063-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1211583/000110465922109063/tm2228337d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-22-109063
- JSON: https://secwatch.observer/filing/0001104659-22-109063.json
- Plain text: https://secwatch.observer/filing/0001104659-22-109063.txt

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