---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-22-037426"
form_type: "8-K"
ticker: "FENC"
cik: "0001211583"
company_name: "FENNEC PHARMACEUTICALS INC."
filed_at: "2022-03-24T23:59:59+00:00"
generated_at: "2026-06-26T18:06:55.821518+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Fennec resubmits NDA to FDA for PEDMARK to prevent pediatric ototoxicity

## Summary
- Resubmitted New Drug Application (NDA) for PEDMARK (sodium thiosulfate anhydrous injection).
- Indication: prevent platinum-induced ototoxicity in pediatric patients (1 month to <18 years) with localized solid tumors.
- CEO Rosty Raykov cited close work with FDA during the review process.

## SEC filing metadata
- accession: 0001104659-22-037426
- form_type: 8-K
- ticker: FENC
- cik: 0001211583
- company_name: FENNEC PHARMACEUTICALS INC.
- filed_at: 2022-03-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1211583/000110465922037426/0001104659-22-037426-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1211583/000110465922037426/tm2210369_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-22-037426
- JSON: https://secwatch.observer/filing/0001104659-22-037426.json
- Plain text: https://secwatch.observer/filing/0001104659-22-037426.txt

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