Praxis Precision reaches alignment with FDA for relutrigine program

Praxis Precision (PRAX) Medicines announced that, following a comprehensive Type B meeting and recent meeting minutes and written advice on the protocol and SAP, it has reached alignment with the FDA on several aspects of the relutrigine program in SCN2A and SCN8A developmental and epileptic encephalopathies, including the use of the ongoing EMBOLD study to serve as the basis of substantial evidence of effectiveness for the NDA submission. The FDA agreed that Praxis’ proposed interim analysis, if positive, may serve as the basis of the NDA submission in early 2026. The interim analysis is planned to be conducted in the fourth quarter of 2025.