Neuren Pharmaceuticals secures European approval for DAYBUE drug

• Neuren Pharmaceuticals' partner Acadia Pharmaceuticals received European Commission marketing authorisation for DAYBUE (trofinetide) to treat Rett syndrome.
• Neuren is entitled to receive US$35 million after the first commercial sale in Europe, alongside milestone payments up to US$170 million and tiered royalties.
• The commercial rollout is expected to begin in Germany in early Q4 2026 to address neurobehavioural symptoms in Rett syndrome patients aged five and older.

Neuren Pharmaceuticals (ASX:NEU) secured European Commission marketing authorisation for DAYBUE (trofinetide) to treat neurobehavioural symptoms of Rett syndrome in adults and children aged five and older.

The approval expands DAYBUE as the first and only authorised treatment for Rett syndrome across all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway.

"The European Commission’s approval of DAYBU is particularly rewarding for Neuren given our long-standing commitment to developing therapies for serious neurological disorders with profound unmet need," said Neuren CEO Jon Pilcher.

Under the licensing agreement, Neuren is eligible for up to US$170 million in potential sales milestone payments, plus tiered royalties ranging from mid-teen to low-20s percentage points of net sales.

Acadia Pharmaceuticals (NASDAQ:ACAD) plans to initiate its initial European commercial launch in Germany in early Q4 2026.

Following the announcement, the Neuren share price was up at $22.68.

Neuren develops drug therapies for serious neurological disorders caused by genetic abnormalities or brain injury that currently lack approved treatment options.

The company's oral solution DAYBUE is already approved by regulatory authorities in the United States, Canada, and Israel, though it remains unapproved for sale in Australia.