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Neuren Pharmaceuticals Limited (ASX:NEU)

ALERT: Price-sensitive ASX Announcement for NEU
Current share price for NEU : $16.690 4.49 (36.80%)+
Announcement
Release
29 Jun 2026 7:43AM
Price at Release
$12.200
Full Release
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Summary
Neuren Pharmaceuticals Limited announced that DAYBU® (trofinetide) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending European Union marketing authorisation for the treatment of neurobehavioral symptoms of Rett syndrome. If approved by the European Commission, DAYBU® would be the first approved therapy for Rett syndrome in the EU, covering all member states as well as Iceland, Liechtenstein, and Norway. Neuren is set to receive US$35 million upon first commercial sale in the EU, in addition to royalties and milestone payments from Acadia Pharmaceuticals Inc., their partner for the commercialisation of trofinetide. The approval would mark a significant advancement for patients and caregivers impacted by Rett syndrome.
Key Points
  • CHMP adopted a positive opinion for DAYBU®.
  • DAYBU® would be the first treatment for Rett syndrome in the EU.
  • Neuren to receive US$35 million upon first EU sale.
  • DAYBU® targets neurobehavioral symptoms in Rett syndrome.
  • Marketing authorisation covers all EU states plus Iceland, Liechtenstein, and Norway.
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.