Why has Neuren Pharmaceuticals (ASX:NEU) issued an update on DAYBU in Europe?

Neuren Pharmaceuticals (ASX:NEU) has updated investors because the CHMP has given a positive opinion recommending EU marketing authorisation for DAYBU (trofinetide) for Rett syndrome neurobehavioral symptoms, which, if confirmed by the European Commission, would trigger milestone and royalty payments to Neuren under its licence with Acadia.

What are the key financial terms for Neuren Pharmaceuticals (ASX:NEU) if DAYBU is approved and launched in the EU?

If DAYBU is approved and launched in the EU, Neuren Pharmaceuticals (ASX:NEU) expects to receive US$35 million upon first commercial sale, up to US$170 million in sales milestone payments linked to rising annual net sales thresholds and tiered royalties in the mid‑teens to low‑20s percent range on net sales.

How is DAYBU positioned within Neuren Pharmaceuticals’ (ASX:NEU) global Rett syndrome strategy?

DAYBU (trofinetide) is already approved in the US, Canada and Israel for Rett syndrome, and Neuren Pharmaceuticals (ASX:NEU) says the potential EU approval would extend its reach to all 27 EU states and certain EEA countries, supporting Acadia’s commercial rollout while Neuren focuses on pipeline development and collects licence‑based revenue.

What does the CHMP’s positive opinion mean for the European regulatory process affecting Neuren Pharmaceuticals (ASX:NEU)?

The CHMP’s positive opinion means the European Commission will now review DAYBU’s application; Neuren Pharmaceuticals (ASX:NEU) states that a Commission approval would grant a centralised marketing authorisation covering the EU and some neighbouring countries, while the timing and final decision remain subject to the Commission’s assessment.

How does Neuren Pharmaceuticals’ (ASX:NEU) broader pipeline relate to the DAYBU update?

Neuren Pharmaceuticals (ASX:NEU) notes that the DAYBU update sits alongside clinical progress for NNZ‑2591, which is in Phase 2 and Phase 3 trials for conditions such as Phelan‑McDermid, Pitt Hopkins and Angelman syndromes, all holding orphan drug and Fast Track designations, as part of its strategy to develop IGF‑1‑targeted therapies across multiple serious neurological disorders.

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DAYBU nears EU green light, unlocking US$35m upfront for Neuren Pharmaceuticals

Written by Liezl GambePublished Jun 29, 2026, 3:01 AM

Neuren Pharmaceuticals (ASX:NEU) says its partner Acadia has received a positive CHMP opinion recommending EU approval of DAYBU (trofinetide)
If the European Commission grants marketing authorisation and DAYBU is launched, Neuren expects to receive US$35 million on first EU commercial sale
Neuren Pharmaceuticals (ASX:NEU) states it will also be entitled to tiered royalties and up to US$170 million in EU sales milestone payments under its licence deal

Neuren Pharmaceuticals (ASX:NEU) says the European Medicines Agency’s CHMP has adopted a positive opinion, after re‑examination, recommending the European Commission grant marketing authorisation for DAYBU (trofinetide) to treat neurobehavioral symptoms of Rett syndrome in adults and children aged five and over.

The opinion follows an earlier CHMP review and would, if confirmed by the Commission, make DAYBU the first approved therapy for these Rett syndrome symptoms in the EU, expanding on existing approvals in the United States, Canada and Israel and aligning with Neuren’s strategy to grow trofinetide’s global footprint via its partner Acadia.

“I am so delighted for all stakeholders to see this positive outcome from the CHMP re‑examination process recommending marketing authorisation for DAYBU in the EU,” said Neuren CEO Jon Pilcher.

Neuren has granted Acadia an exclusive worldwide licence for trofinetide and says that, in Europe, it is entitled to receive US$35 million upon first commercial sale, plus up to US$170 million in sales milestone payments tied to escalating annual net sales thresholds and tiered royalties from the mid‑teens to low‑20s percent on net sales.

The company notes that the CHMP recommendation now goes to the European Commission, which is expected to issue a final decision in the coming months, and that any marketing authorisation would apply across all 27 EU member states plus Iceland, Liechtenstein and Norway.

Neuren highlights that DAYBU builds on its broader rare disease portfolio, which includes NNZ‑2591 in Phase 2 and Phase 3 trials for several neurodevelopmental disorders with orphan drug, Fast Track and Rare Pediatric Disease designations, as the company targets IGF‑1‑related pathways in genetic and brain‑injury‑related conditions.

At the time of reporting, Neuren Pharmaceuticals (ASX:NEU) share price was AUD 15.94.

DAYBU nears EU green light, unlocking US$35m upfront for Neuren Pharmaceuticals

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