Praxis Precision Medicines, Inc. (PRAX) on Monday said the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to ulixacaltamide for the treatment of patients with essential tremor.
The designation was based on positive topline data from the Essential3 program, including two pivotal Phase 3 studies evaluating ulixacaltamide in essential tremor.
Praxis said it expects to submit a New Drug Application for ulixacaltamide in early 2026.
Praxis Precision Medicines shares were up more than 11% in pre-market trading after closing at $268.95, down 2.11% on Friday.
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