Biopharmaceutical company Praxis Precision Medicines, Inc. (PRAX) announced Tuesday that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for ulixacaltamide HCl for the treatment of essential tremor (ET) in adults.
The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 29, 2027 and is not planning to hold an advisory committee meeting.
The NDA is supported by positive results from the Essential3 Phase 3 program, which comprised two simultaneously enrolled pivotal studies in adults with essential tremor.
The statistically and clinically significant results from the Essential3 program provide the primary evidence of effectiveness for the NDA submission.
Ulixacaltamide was generally well tolerated, with a safety profile consistent with previous trials and no drug-related serious adverse events. Ulixacaltamide received Breakthrough Therapy Designation (BTD) from the FDA in December 2025.
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