Acadia Expects Negative Opinion from EU Regulators for Rett Syndrome Treatment

Dow Jones

Feb 03

By Kelly Cloonan

Acadia Pharmaceuticals said that drug regulators in Europe are leaning toward rejecting its application for a neurodevelopmental disorder treatment.

The company said Monday it was informed by a committee from the European Medicines Agency of a negative trend vote on its marketing authorization application for trofinetide for the treatment of Rett syndrome.

The committee will vote on the application in February, Acadia said.

The company intends to request a re-examination of the opinion upon the formal vote.

Rett syndrome is a rare neurodevelopmental disorder that occurs in about one of every 10,000 to 15,000 female births worldwide. It can cause children to lose motor skills and acquired communication skills.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

February 02, 2026 16:30 ET (21:30 GMT)

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It can cause children to lose motor skills and acquired communication skills. \n\n\n \n\n\n  Write to Kelly Cloonan at kelly.cloonan@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  February 02, 2026 16:30 ET (21:30 GMT)\n\n\n  Copyright (c) 2026 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":"-2","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}