Neuren Flags EU Regulatory Hurdle for Trofinetide.
Neuren Pharmaceuticals (ASX: NEU) advised that its commercial partner, Acadia Pharmaceuticals, has encountered a regulatory setback in Europe for trofinetide, a treatment for Rett syndrome. The European Medicines Agency’s CHMP has issued a negative trend vote on the drug’s marketing application following recent discussions with regulators. While the final opinion is yet to be formally adopted, Acadia plans to seek a re-examination if the unfavourable position is confirmed in February.
Despite the development, management emphasised trofinetide’s established clinical profile, noting its existing approvals in several international markets and extensive real-world usage across a wide age range of patients. Neuren expressed frustration with the preliminary outcome but reiterated its confidence in the therapy’s demonstrated benefits and safety record. Both Neuren and Acadia remain engaged with European regulators and continue to pursue pathways to make trofinetide available to patients in the European Union who currently have limited treatment options.
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Neuren Flags EU Regulatory Hurdle for Trofinetide.
Neuren Pharmaceuticals (ASX: NEU) advised that its commercial partner, Acadia Pharmaceuticals, has encountered a regulatory setback in Europe for trofinetide, a treatment for Rett syndrome. The European Medicines Agency’s CHMP has issued a negative trend vote on the drug’s marketing application following recent discussions with regulators. While the final opinion is yet to be formally adopted, Acadia plans to seek a re-examination if the unfavourable position is confirmed in February.
Despite the development, management emphasised trofinetide’s established clinical profile, noting its existing approvals in several international markets and extensive real-world usage across a wide age range of patients. Neuren expressed frustration with the preliminary outcome but reiterated its confidence in the therapy’s demonstrated benefits and safety record. Both Neuren and Acadia remain engaged with European regulators and continue to pursue pathways to make trofinetide available to patients in the European Union who currently have limited treatment options.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au