Praxis NDA Accepted by FDA

Praxis Precision Medicines announced on April 14, 2026, that the United States — Food and Drug Administration accepted its New Drug Application (NDA) for ulixacaltamide HCl, a treatment for essential tremor in adults. The United States — Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) target action date of January 29, 2027, and does not plan to hold an advisory committee meeting. This NDA is supported by positive results from the Essential3 Phase 3 program, which demonstrated statistically and clinically significant effectiveness and a consistent safety profile for ulixacaltamide HCl. Márcio Souza, president and CEO of Praxis Precision Medicines, highlighted this as a step closer to delivering a specific therapy for patients with essential tremor. Ulixacaltamide HCl previously received Breakthrough Therapy Designation from the United States — Food and Drug Administration in December 2025.