FDA sets updated PDUFA date of December 27, 2026

BOSTON, June 29, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) notified Praxis that it has extended by three months the review period for its New Drug Application (NDA) for relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs), setting an updated PDUFA target action date from September 27, 2026 to December 27, 2026. The extension follows Praxis's submission of additional sensitivity analyses of existing clinical data, which the FDA has deemed a "major amendment," allowing additional time for the FDA to review. No new clinical studies were requested, and the FDA did not cite any safety or manufacturing concerns. The review remains active and ongoing, and Praxis is continuing its preparations to bring relutrigine to a patient community with significant unmet need. Praxis remains confident in the strength of the relutrigine application and continues to collaborate with the FDA to support the completion of its review.