---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-108565"
form_type: "8-K"
ticker: "FENC"
cik: "0001211583"
company_name: "FENNEC PHARMACEUTICALS INC."
filed_at: "2026-09-17T20:03:17+00:00"
generated_at: "2026-09-17T20:04:06.874309+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Fennec's PEDMARK hits primary endpoint in Japan Phase 2, 24% hearing loss vs 56.4%

## Summary
- Phase 2 STS-J01 met primary endpoint: ASHA-defined hearing loss 24.0% (6/25) vs 56.4% historical benchmark (P=0.001).
- No Grade 3/4 hearing loss by Brock criteria; 84.0% Grade 0 hearing loss.
- Objective tumor responses in 23/24 evaluable patients (95.8%), no interference with cisplatin antitumor activity.
- Company pursuing Japanese registration and exploring partnering/licensing for PEDMARK.
- Safety consistent with known profile; no serious adverse events attributed to PEDMARK.

## SEC filing metadata
- accession: 0001104659-26-108565
- form_type: 8-K
- ticker: FENC
- cik: 0001211583
- company_name: FENNEC PHARMACEUTICALS INC.
- filed_at: 2026-09-17T20:03:17+00:00
- event_type: other_material
- 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/1211583/000110465926108565/0001104659-26-108565-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1211583/000110465926108565/fencf-20260917x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-108565
- JSON: https://secwatch.observer/filing/0001104659-26-108565.json
- Plain text: https://secwatch.observer/filing/0001104659-26-108565.txt

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