---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-117697"
form_type: "8-K"
ticker: "FENC"
cik: "0001211583"
company_name: "FENNEC PHARMACEUTICALS INC."
filed_at: "2025-12-02T23:59:59+00:00"
generated_at: "2026-05-16T15:37:56.009751+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Fennec PEDMARK Phase 2/3 Japan trial meets endpoint; hearing loss reduced to 16-24% vs 56-63% historical

## Summary
- Primary endpoint met: hearing loss in 24% (ASHA) and 16% (Brock) of evaluable patients vs 56-63% historically.
- Tumor response rate ~95%, showing PEDMARK does not interfere with cisplatin antitumor activity.
- Company plans to pursue registration in Japan and explore partnering or licensing opportunities.
- Study enrolled 27 patients aged 3-18 years in primary cohort; PEDMARK well-tolerated with no attributed adverse events.

## SEC filing metadata
- accession: 0001104659-25-117697
- form_type: 8-K
- ticker: FENC
- cik: 0001211583
- company_name: FENNEC PHARMACEUTICALS INC.
- filed_at: 2025-12-02T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1211583/000110465925117697/0001104659-25-117697-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1211583/000110465925117697/tm2532518d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-117697
- JSON: https://secwatch.observer/filing/0001104659-25-117697.json
- Plain text: https://secwatch.observer/filing/0001104659-25-117697.txt

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