Neuren Pharmaceuticals Ltd (ASX:NEU) partner Acadia Pharmaceuticals expects global net sales of DAYBUE to reach approximately US$700 million in 2028, underpinned by new product formats, expanding patient uptake in the United States and international market growth.
The update follows Acadia’s presentation at the 44th annual J.P. Morgan Healthcare Conference, where the US-based company outlined its medium-term commercial outlook for DAYBUE (trofinetide), which is approved by the US Food and Drug Administration for the treatment of Rett syndrome.
STIX rollout and US execution focus
Growth is expected to be driven by the rollout of DAYBUE STIX, a powder formulation approved by the FDA in December 2025. The new formulation is expected to address barriers for patients who declined or discontinued the existing liquid version, potentially supporting higher patient penetration over time.
A limited US rollout of DAYBUE STIX has begun, with full availability anticipated by the beginning of the June 2026 quarter. Acadia also pointed to the benefits of its expanded US customer-facing teams, following a scale-up in the June 2025 quarter, as well as further international expansion opportunities.
Patient uptake, persistency and international steps
Since its US launch in 2023, more than 2,000 Rett syndrome patients have been treated with DAYBUE. Acadia reported that 12-month persistency has increased to 55%, while more than 300 patients are now participating in the LOTUS real-world outcomes study, which continues to generate and publish data on long-term use.
The estimated number of diagnosed Rett syndrome patients in the US has risen to around 6,000, up approximately 30% since DAYBUE’s launch, reflecting improved diagnosis and disease awareness.
Outside the US, Acadia confirmed that DAYBUE oral solution has been approved by Israel’s Ministry of Health, marking another step in its international commercialisation strategy. In Europe, a Committee for Medicinal Products for Human Use (CHMP) opinion is anticipated in the March 2026 quarter.
Meanwhile, the Phase 3 clinical trial of trofinetide in Japan remains ongoing, with top-line results expected between the December 2026 and March 2027 quarters.
Neuren has licensed the worldwide development and commercialisation rights for trofinetide to Acadia. The company’s second clinical asset, NNZ-2591, continues development across multiple neurodevelopmental disorders, with Phase 2 trials completed in several indications.