Praxis Precision Medicines shares fall after hours as the US FDA extends the review period for its epilepsy drug by 3 months

Affected by this news, the company's stock price fell 5.9% after hours. The FDA has set a revised PDUFA (Prescription Drug User Fee Act) target action date for December 27, 2026, instead of the previous PDUFA date of September 27. This postponement occurred after Praxis submitted an additional sensitivity analysis regarding existing clinical data. The FDA has classified this submission as a major amendment, thereby allowing additional review time. The FDA has not requested any new clinical studies nor raised any concerns related to safety or manufacturing.