Fennec gets EU approval for Pedmarqsi to prevent cisplatin-induced hearing loss in children

FENNEC PHARMACEUTICALS INC.

European Commission granted marketing authorization for Pedmarqsi (sodium thiosulfate) for pediatric localized solid tumors.
First and only approved therapy in EU for preventing cisplatin-induced ototoxicity; includes 8+2 years data/market protection.
Approval based on Phase 3 trials SIOPEL 6 and COG ACCL0431; applies to all 27 EU states plus Iceland, Norway, Liechtenstein.
PEDMARK already FDA-approved in U.S. since September 2022; Fennec expects to make Pedmarqsi available in EU soon.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.