Fennec's Pedmark Shows Strong Hearing Protection in Japanese Study — Fennec Pharmaceuticals Inc.

Event summary

Fennec Pharmaceuticals presented Phase 2 STS-J01 study results at SIOP 2026, showing Pedmark reduced hearing loss to 24% vs. historical benchmark of 56.4% (P=0.001).
84% of patients had Grade 0 hearing loss by Brock criteria, with no Grade 3 or 4 hearing loss observed.
Objective tumor responses were seen in 95.8% of evaluable patients, confirming no interference with cisplatin's antitumor activity.
Fennec is pursuing Pedmark's registration in Japan and exploring partnering opportunities.

The big picture

Fennec's positive Phase 2 data for Pedmark in Japan reinforces its position as the only FDA-approved therapy for reducing cisplatin-induced hearing loss. The study's success in maintaining antitumor efficacy while protecting hearing could accelerate global adoption, particularly in high-cisplatin-use markets. With existing partnerships like Norgine for European commercialization, Fennec is well-positioned to expand Pedmark's reach, though regulatory hurdles and competitive dynamics remain key variables.

What we're watching

Regulatory Strategy: Whether Fennec can successfully navigate Pedmark's registration process in Japan and secure additional international approvals.
Commercial Expansion: The pace at which Fennec can identify and secure partnering or licensing deals for Pedmark in new markets.
Clinical Validation: How these results will influence future clinical adoption and reimbursement discussions for Pedmark in both pediatric and AYA populations.