secwatch.observer — SEC 8-K summary
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Issuer:     FENNEC PHARMACEUTICALS INC. (FENC)
CIK:        0001211583
Form:       8-K
Filed at:   2026-09-17T20:03:17+00:00
Accession:  0001104659-26-108565
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1211583/000110465926108565/0001104659-26-108565-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1211583/000110465926108565/fencf-20260917x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-108565

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer