The schedule shift stems from the company providing additional sensitivity analyses of existing clinical trial results. The FDA categorized this submission as a major amendment to the original application, necessitating the extra time for evaluation. Praxis officials confirmed that the agency has not requested new clinical studies, nor have any safety or manufacturing issues surfaced during the ongoing review process.

Relutrigine targets seizures triggered by specific SCN2A and SCN8A gene mutations. Praxis continues to coordinate with regulators to facilitate the remaining stages of the application review.