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Neuren Pharmaceuticals Limited (ASX:NEU)

ALERT: Price-sensitive ASX Announcement for NEU
Current share price for NEU : $16.690 2.92 (21.21%)+
Announcement
Release
3 Mar 2026 9:50AM
Price at Release
$13.770
Full Release
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Summary
Neuren Pharmaceuticals Limited, listed on the ASX, has confirmed that its partner Acadia Pharmaceuticals plans to request a re-examination of the opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency regarding trofinetide's marketing authorization for treating Rett syndrome. Despite approval in the US, Canada, and Israel, the CHMP has refused approval in Europe citing limited treatment effect and issues with study design. Neuren's CEO, Jon Pilcher, expressed support for the re-examination, emphasizing the unmet medical need in Europe. Trofinetide has been making a difference in approved markets, and its approval in Europe remains a priority.
Key Points
  • Acadia Pharmaceuticals plans to request CHMP re-examination for trofinetide.
  • Trofinetide approved in the US, Canada, and Israel.
  • CHMP refused approval citing limited treatment effect and study design issues.
  • Neuren Pharmaceuticals supports re-examination.
  • Trofinetide has been effective in approved markets.
  • There is a substantial unmet medical need for Rett syndrome treatment in Europe.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.