---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-22-101910"
form_type: "8-K"
ticker: "FENC"
cik: "0001211583"
company_name: "FENNEC PHARMACEUTICALS INC."
filed_at: "2022-09-21T23:59:59+00:00"
generated_at: "2026-06-23T08:13:48.849683+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Fennec Pharma gets FDA approval for PEDMARK to reduce cisplatin-induced hearing loss in pediatric patients

## Summary
- FDA approved PEDMARK (sodium thiosulfate) for reducing ototoxicity in children aged 1 month+ with localized, non-metastatic solid tumors.
- PEDMARK is first and only FDA-approved therapy for this indication; based on two Phase 3 trials (SIOPEL6, COG ACCL0431).
- Hearing loss incidence: 21.4% vs 73.3% (COG ACCL0431, p=0.005) and 32.7% vs 63% (SIOPEL6, p=0.002) with PEDMARK plus cisplatin vs cisplatin alone.
- Common adverse reactions include vomiting, nausea, decreased hemoglobin, hypernatremia, hypokalemia; monitor electrolytes.
- PEDMARK also holds FDA Orphan Drug designation; EU MAA for PEDMARQSI is under EMA evaluation.

## SEC filing metadata
- accession: 0001104659-22-101910
- form_type: 8-K
- ticker: FENC
- cik: 0001211583
- company_name: FENNEC PHARMACEUTICALS INC.
- filed_at: 2022-09-21T23:59:59+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/1211583/000110465922101910/0001104659-22-101910-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1211583/000110465922101910/tm2226408d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-22-101910
- JSON: https://secwatch.observer/filing/0001104659-22-101910.json
- Plain text: https://secwatch.observer/filing/0001104659-22-101910.txt

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