Praxis Completes FDA Meeting for Tremor Treatment, Reports Positive Results for Epilepsy Drug

Praxis Precision Medicine has completed its pre-new drug application meeting with the FDA for its essential tremor treatment, ulixacaltamide. The company expects to file the NDA in early 2026. Praxis also reported positive results from a Phase 2 study evaluating relutrigine for developmental and epileptic encephalopathies, with a well-tolerated safety profile and improvement in motor seizures. The FDA has confirmed a meeting to review the data, with the company to determine the timeline for filing an NDA after the meeting.