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Praxis Precision Medicines Announces FDA Acceptance of New Drug Application for Ulixacaltamide HCl in Patients with Essential Tremor
FDA assigned PDUFA target action date of January 29, 2027 No advisory committee meeting expected BOSTON, April 14, 2026 (GLOBE NEWSWIRE) -- Praxis Precision
About this update from Praxis Precision Medicines, Inc.
[{"type":"text","content":"FDA assigned PDUFA target action date of January 29, 2027 No advisory committee meeting expected BOSTON, April 14, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced 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. “Today’s announcement brings us one step closer to delivering something patients living with essential tremor have been waiting for, a therapy developed specifically for their condition,” said Marcio Souza, president and chief executive officer. “We look forward to continuing to work with the FDA through the review process while we prepare for the commercial launch.” Ulixacaltamide for treatment of essential tremor 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. About UlixacaltamideUlixacaltamide is a differentiated and highly selective small molecule inhibitor of T-type calcium channels designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical (CTC) circuit correlated with tremor activity. Ulixacaltamide has received Breakthrough Therapy Designation from the FDA and is the most advanced program within Praxis’ Cerebrum™ small molecule platform. About Praxis Praxis Precision Medicines is a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, translating insights from genetic epilepsies into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance. Praxis is app...