FDA Extends Relutrigine Review, Delays PDUFA to December

The FDA has extended its review of Praxis Precision Medicines' relutrigine for SCN2A- and SCN8A-related epilepsies, delaying the PDUFA date to December 27, 2026. The extension follows additional sensitivity analyses of existing clinical data, with no new safety or manufacturing concerns raised, and prior positive efficacy and safety data from EMBOLD studies support the application.

This Wire brief sits within Fusion42's coverage of Biotech.