---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-130855"
form_type: "8-K"
ticker: "FENC"
cik: "0001211583"
company_name: "FENNEC PHARMACEUTICALS INC."
filed_at: "2024-12-20T23:59:59+00:00"
generated_at: "2026-05-29T00:05:14.941208+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Fennec announces NICE recommends PEDMARQSI for cisplatin-induced hearing loss in children in England and Wales

## Summary
- NICE issued positive final draft guidance recommending PEDMARQSI for prevention of cisplatin-induced hearing loss in patients aged 1 month-17 years with localized solid tumors.
- First and only approved therapy in EU/U.K. for cisplatin-induced ototoxicity prevention; Phase 3 trials showed ~50% reduction in hearing loss.
- Fennec's partner Norgine will commercialize in Europe; Fennec received ~$43M upfront and is eligible for up to ~$230M milestones plus double-digit tiered royalties.
- Until now, no preventative pharmacological intervention was available despite significant lifelong impact of hearing loss on pediatric cancer patients.

## SEC filing metadata
- accession: 0001104659-24-130855
- form_type: 8-K
- ticker: FENC
- cik: 0001211583
- company_name: FENNEC PHARMACEUTICALS INC.
- filed_at: 2024-12-20T23:59:59+00:00
- event_type: regulatory
- 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/1211583/000110465924130855/0001104659-24-130855-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1211583/000110465924130855/tm2431725d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-130855
- JSON: https://secwatch.observer/filing/0001104659-24-130855.json
- Plain text: https://secwatch.observer/filing/0001104659-24-130855.txt

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