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Praxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential Tremor

PRAX
  • The FDA granted Breakthrough Therapy Designation for ulixacaltamide to treat essential tremor based on positive topline results from the Essential3 Phase 3 program.
  • Praxis Precision Medicines aligns with the FDA on NDA content following a completed pre-NDA meeting & expects to submit the NDA in early 2026.
  • The Breakthrough Therapy Designation facilitates expedited development & regulatory review for this serious condition where preliminary evidence suggests substantial improvement over existing therapies.
  • The Essential3 program consists of two pivotal Phase 3 studies demonstrating the efficacy of ulixacaltamide, a selective T-type calcium channel inhibitor.
  • Essential tremor affects approximately seven million people in the U.S., yet current treatments like propranolol offer limited efficacy & tolerability, leaving many patients without effective options.
  • Ulixacaltamide is designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical circuit & represents the most advanced program in Praxis' Cerebrum™ platform.
  • Praxis is a clinical-stage biopharmaceutical company focused on CNS disorders characterized by neuronal excitation-inhibition imbalance using its Cerebrum™ small molecule & Solidus™ antisense oligonucleotide platforms.