By Anvee Bhutani
Praxis Precision Medicines said Monday the Food and Drug Administration extended its review of the company's application for relutrigine, an epilepsy treatment, delaying a decision by three months.
The FDA set a new target decision date of Dec. 27, 2026, from Sept. 27, after the company submitted additional sensitivity analyses of existing clinical trial data that the agency classified as a major amendment.
Praxis said the FDA didn't request any new clinical studies and didn't identify any safety or manufacturing concerns. The company said it continues to work with the agency as the review remains ongoing.
Relutrigine is being reviewed as a treatment for rare forms of childhood epilepsy caused by SCN2A and SCN8A gene mutations.
Write to Anvee Bhutani at anvee.bhutani@wsj.com