Praxis Precision Medicines Shares Rise on Positive Preliminary Meeting with FDA for Essential Tremor Treatment

Dow Jones

12/05

By Adriano Marchese

Shares is Praxis Precision Medicines rose in premarket trading Friday after it said it expects to submit to U.S. regulators a new drug application next year for its investigational drug to treat essential tremors.

Shares traded 25% higher ahead of the morning bell at $237.10.

The clinical-stage biopharmaceutical company said Thursday that it expects to submit its NDA early in 2026 after a preliminary meeting with the Food and Drug Administration regarding its drug ulixacaltamide.

Ulixacaltamide is Praxis' investigational drug aimed at treating essential tremors, a neurological movement disorder that causes involuntary shaking, most often in the hands, but it also can affect other body parts such as the head or the voice. It is the most common type of tremor and is distinct from Parkinson's disease.

From its meeting with the FDA, Praxis said it has reached an understanding with regulators on the required content of the application and anticipates completing the submission early next year.

Write to Adriano Marchese at adriano.marchese@wsj.com

(END) Dow Jones Newswires

December 05, 2025 06:33 ET (11:33 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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It is the most common type of tremor and is distinct from Parkinson's disease. \n</p>\n<p>\n  From its meeting with the FDA, Praxis said it has reached an understanding with regulators on the required content of the application and anticipates completing the submission early next year. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Adriano Marchese at adriano.marchese@wsj.com \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  December 05, 2025 06:33 ET (11:33 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Praxis Precision Medicines Shares Rise on Positive Preliminary Meeting with FDA for Essential Tremor Treatment</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; 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It is the most common type of tremor and is distinct from Parkinson's disease. \n\n\n  From its meeting with the FDA, Praxis said it has reached an understanding with regulators on the required content of the application and anticipates completing the submission early next year. \n\n\n \n\n\n  Write to Adriano Marchese at adriano.marchese@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  December 05, 2025 06:33 ET (11:33 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}