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

The FDA extended the review period for Praxis Precision Medicines' New Drug Application (NDA) for relutrigine by three months, setting a new PDUFA target action date of December 27, 2026. The extension follows the company's submission of additional sensitivity analyses classified as a major amendment, with no new clinical studies requested and no safety or manufacturing concerns cited.

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