other material
confidence high
sentiment positive
materiality 0.85
Fennec's PEDMARK hits primary endpoint in Japan Phase 2, 24% hearing loss vs 56.4%
FENNEC PHARMACEUTICALS INC.
- 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.
Featured in Daily 8-K Digest
Selected #10 for 2026-09-17.
Read digest