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 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.