Praxis Precision Medicines Stock Drops 5.9% After FDA Extends Relutrigine Review by 3 Months

Praxis Precision Medicines announced on June 29 that the FDA extended its review period for relutrigine, a drug candidate for SCN2A and SCN8A developmental and epileptic encephalopathy, by three months. The updated PDUFA target action date is now December 27, 2026, compared to the previous date of September 27, 2026.

The stock declined 5.9% in after-hours trading following the announcement. The extension came after Praxis submitted additional sensitivity analyses on existing clinical data, which the FDA classified as a major amendment. The FDA did not request new clinical studies or raise safety or manufacturing concerns.