FDA extends review of Praxis drug for rare epilepsy to December 2026

Go back to FDA extends review of Praxis drug for rare epilepsy to December 2026

Praxis Precision Medicines Announces Extension Period for Relutrigine for Treatment of SCN2A and SCN8A Developmental and Epileptic Encephalopathies

June 29, 2026 4:30 PM EDT

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)... More