The U.S. Food and Drug Administration (FDA) has extended the review period for Praxis Precision Medicines' New Drug Application (NDA) for relutrigine by three months. The updated target action date is now December 27, 2026, moved from September 27, 2026. This extension is due to the Company's submission of additional sensitivity analyses of existing clinical data, which the FDA has classified as a major amendment. The FDA did not request new clinical studies and has not cited any safety or manufacturing concerns. Praxis Precision Medicines remains confident in the relutrigine application and is collaborating with the FDA.