Praxis Precision Medicines FDA Extends Relutrigine NDA Review to Dec 27

Praxis Precision Medicines announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its New Drug Application (NDA) for relutrigine by three months. The new PDUFA target action date is December 27, 2026, pushed from September 27, 2026. This extension follows the company's submission of additional sensitivity analyses of existing clinical data, which the FDA classified as a "major amendment." The FDA did not request new clinical studies or cite any safety or manufacturing concerns, and the review remains active.