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Neuren Pharmaceuticals Limited (ASX:NEU)

ALERT: Price-sensitive ASX Announcement for NEU
Current share price for NEU : $20.660 -1.79 (-7.97%)+
Announcement
Release
25 Aug 2026 8:31AM
Price at Release
$22.450
Full Release
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Summary
Neuren Pharmaceuticals Limited announced that the European Commission has granted marketing authorisation for DAYBU (trofinetide) for treating neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five and older. This approval, which makes DAYBU the first treatment for Rett syndrome in the EU, includes all 27 EU member states as well as Iceland, Liechtenstein, and Norway. Neuren's partner, Acadia Pharmaceuticals, anticipates launching the product in Germany by early Q4 2026. Under a licensing agreement, Neuren will receive payments and royalties based on sales in Europe. Trofinetide is also approved in the US, Canada, and Israel, but not yet in Australia.
Key Points
  • European Commission grants marketing authorisation for DAYBU (trofinetide).
  • DAYBU is the first approved treatment for Rett syndrome in the EU.
  • Approval covers 27 EU member states, Iceland, Liechtenstein, and Norway.
  • Commercial launch in Germany expected early Q4 2026.
  • Neuren to receive US$35 million following first commercial sale in Europe.
  • Potential sales milestone payments up to US$170 million.
  • Trofinetide is also approved in the US, Canada, and Israel, but not in Australia.
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.