regulatory
confidence high
sentiment positive
materiality 0.75
Fennec announces NICE recommends PEDMARQSI for cisplatin-induced hearing loss in children in England and Wales
FENNEC PHARMACEUTICALS INC.
- NICE issued positive final draft guidance recommending PEDMARQSI for prevention of cisplatin-induced hearing loss in patients aged 1 month-17 years with localized solid tumors.
- First and only approved therapy in EU/U.K. for cisplatin-induced ototoxicity prevention; Phase 3 trials showed ~50% reduction in hearing loss.
- Fennec's partner Norgine will commercialize in Europe; Fennec received ~$43M upfront and is eligible for up to ~$230M milestones plus double-digit tiered royalties.
- Until now, no preventative pharmacological intervention was available despite significant lifelong impact of hearing loss on pediatric cancer patients.