other material
confidence high
sentiment positive
materiality 0.70
Fennec PEDMARK Phase 2/3 Japan trial meets endpoint; hearing loss reduced to 16-24% vs 56-63% historical
FENNEC PHARMACEUTICALS INC.
- 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.