DAYBUE Sales Forecast to Reach US$700 Million by 2028, Driven by US Launch and International Expansion
Neuren Pharmaceuticals’ partner Acadia projects DAYBUE sales to reach around US$700 million by 2028, driven by US market expansion and international approvals. The launch of a new formulation and ongoing clinical trials in Japan underpin this optimistic outlook.
- DAYBUE global net sales forecast to reach ~US$700 million by 2028
- Over 2,000 Rett syndrome patients treated in the US since 2023 launch
- New DAYBUE STIX powder formulation launching fully by Q2 2026 in the US
- DAYBUE oral solution approved in Israel, with Japan Phase 3 trial results expected late 2026/early 2027
- 12-month patient persistency improved to 55%, supporting sustained treatment uptake
Strong Sales Momentum in the US
Neuren Pharmaceuticals (ASX, NEU) has revealed promising growth prospects for its Rett syndrome treatment DAYBUE (trofinetide), following a presentation by its partner Acadia Pharmaceuticals at the recent J.P. Morgan Healthcare Conference. Since its US launch in 2023, DAYBUE has been prescribed to over 2,000 patients, with a notable 55% of those patients continuing treatment after 12 months. This level of persistency signals strong patient and caregiver acceptance, a critical factor for long-term commercial success in rare disease therapies.
New Formulation and Market Expansion Drive Growth
Acadia’s projection of approximately US$700 million in global net sales by 2028 is underpinned by several strategic initiatives. The rollout of DAYBUE STIX, a new powder formulation approved by the US FDA in December 2025, aims to attract patients who previously declined or discontinued the liquid version. This innovation could broaden the patient base and improve adherence. Additionally, Acadia has expanded its US customer-facing teams since mid-2025, enhancing outreach and support.
International Approvals and Clinical Trials
Beyond the US, DAYBUE has gained approval from Israel’s Ministry of Health for its oral solution, marking a significant step in international expansion. Meanwhile, a Phase 3 clinical trial in Japan is ongoing, with top-line results expected between late 2026 and early 2027. Positive data from this trial could open the door to further regulatory approvals and market entry in Asia. Acadia also anticipates a European regulatory opinion in early 2026, which would further broaden DAYBUE’s global footprint.
Neuren’s Pipeline and Orphan Drug Focus
While DAYBUE remains Neuren’s flagship product, the company is advancing other neurodevelopmental disorder treatments, including NNZ-2591. This candidate has shown encouraging Phase 2 results in rare conditions such as Phelan-McDermid, Pitt Hopkins, and Angelman syndromes, all benefiting from orphan drug designations in the US and EU. These designations provide regulatory incentives and underscore Neuren’s commitment to addressing unmet needs in serious childhood neurological disorders.
Outlook and Market Implications
The combination of expanding patient numbers, improved treatment formulations, and international regulatory progress positions DAYBUE for robust growth over the coming years. However, the ultimate commercial success will hinge on the outcomes of ongoing clinical trials and the ability to secure approvals in key markets like Europe and Japan. Investors will be watching closely as Neuren and Acadia execute their global strategy.
Bottom Line?
DAYBUE’s growth story is gathering pace, but upcoming trial results and international approvals will be pivotal for Neuren’s next phase.
Questions in the middle?
- Will the Phase 3 trial in Japan confirm efficacy and safety to unlock the Asian market?
- How quickly can Acadia scale DAYBUE STIX adoption among patients hesitant about the liquid formulation?
- What impact will European regulatory decisions have on Neuren’s global sales trajectory?
