By Digifin Pty Ltd · About this coverage
Key Points
- Approved for neurobehavioral symptoms of Rett syndrome in patients aged five years and older
- Authorisation covers all 27 EU member states plus Iceland, Liechtenstein and Norway
- For Europe, Neuren entitled to US$35m from licensee Acadia following first commercial sale
- Potential sales milestones of up to US$170m, plus tiered royalties of mid-teens to low-20s per cent
- Acadia has previously said commercial launch in Germany is anticipated in early Q4 2026
About Neuren (ASX:NEU)
Neuren Pharmaceuticals Limited is an ASX-listed biopharmaceutical company headquartered in Melbourne. Its revenue comes principally from royalties and milestone payments on trofinetide, the first drug approved for Rett syndrome, which is commercialised worldwide by Acadia Pharmaceuticals under an exclusive licence. Neuren retains its own candidate NNZ-2591, which is in clinical development for several neurodevelopmental disorders.
Neuren Pharmaceuticals Limited (ASX:NEU) advised that its exclusive global licensee for trofinetide, Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), had announced that the European Commission granted marketing authorisation for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and paediatric patients aged five years and older. Neuren said DAYBU is the first and only treatment approved for Rett syndrome in the European Union, and that with the approval it is authorised to be marketed in all 27 EU member states as well as Iceland, Liechtenstein and Norway. Acadia has previously stated that commercial launch in Germany is anticipated early in the fourth quarter of 2026.
Under the licence agreement, Neuren said that for Europe it is entitled to receive US$35 million following first commercial sale, potential sales milestone payments of up to US$170 million on achievement of escalating annual net sales thresholds, and tiered royalties from mid-teens to low-20s per cent of net sales. Chief Executive Officer Jon Pilcher said the company was delighted for the Rett syndrome community in Europe, “who, until now, have had no approved treatment for this devastating condition”, and that Neuren looked forward to seeing Acadia make DAYBU available for Rett patients and families in Europe. The announcement states that trofinetide is not approved for sale in Australia.
Source: Neuren Pharmaceuticals Limited (ASX:NEU), 25 August 2026. Summary content supplied by Digifin Pty Ltd.
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