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Praxis Precision Medicines Announces FDA Acceptance of New Drug Application for Ulixacaltamide HCl in Patients with Essential Tremor

PRAX
  • FDA accepted Praxis Precision Medicines' New Drug Application (NDA) for ulixacaltamide HCl to treat essential tremor in adults.
  • The FDA set a PDUFA target action date of January 29, 2027, for the application review.
  • No advisory committee meeting is expected to be held regarding this submission.
  • The NDA is supported by statistically & clinically significant results from the Essential3 Phase 3 program.
  • Ulixacaltamide demonstrated a well-tolerated safety profile with no drug-related serious adverse events in trials.
  • The drug received Breakthrough Therapy Designation from the FDA in December 2025.
  • Ulixacaltamide is a selective small molecule inhibitor of T-type calcium channels targeting the Cerebello-Thalamo-Cortical circuit.
  • This program is the most advanced within Praxis' Cerebrum™ small molecule platform.