Neuren Pharmaceuticals reports a 15% rise in 2025 royalties from its partner Acadia’s DAYBUE sales, with strong 2026 guidance signalling further growth. The launch of a new powder formulation and ongoing regulatory efforts in Europe and Japan add to the momentum.
- 2025 DAYBUE net sales reached US$391 million, up 12% year-on-year
- Neuren’s 2025 royalty income rose 15% to A$65 million
- Q4 2025 DAYBUE shipments served a record 1,070 patients
- 2026 sales guidance of US$460–490 million implies royalties of A$70–77 million
- FDA-approved DAYBUE STIX powder launched in limited supply, full rollout expected Q2 2026
Strong Sales Momentum for DAYBUE
Neuren Pharmaceuticals (ASX: NEU) has reported robust financial results for 2025, driven by the continued growth of DAYBUE® (trofinetide), its partner Acadia Pharmaceuticals’ flagship treatment for Rett syndrome. Acadia’s full year 2025 net sales of DAYBUE hit US$391 million, marking a 12% increase over 2024 and setting a new quarterly record with US$110 million in Q4 sales. This steady upward trajectory underscores the drug’s growing acceptance in the US market and international named patient programs.
Royalties Reflect Growing Patient Base
Neuren’s royalty income from DAYBUE climbed 15% year-on-year to A$65 million in 2025, comfortably within its guidance range. The fourth quarter alone generated A$20 million in royalties, a 7% increase compared to the same period last year and a notable 21% rise from the previous quarter. The number of unique patients receiving DAYBUE shipments reached a record 1,070 in Q4, highlighting expanding community uptake, with 76% of new prescriptions coming from physicians outside specialist centres.
New Formulation and Regulatory Developments
Adding to the positive outlook, the FDA approved a new powder formulation of DAYBUE, branded as DAYBUE STIX, in December 2025. This formulation launched on a limited basis in early 2026, with full availability expected by the second quarter. The powder form is anticipated to improve patient adherence by offering an alternative to the liquid formulation, potentially unlocking treatment for families who had previously declined or discontinued therapy.
On the regulatory front, Acadia plans to seek re-examination of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) opinion, with a decision expected by mid-2026. Meanwhile, a Phase 3 clinical trial in Japan is underway, with top-line results anticipated between late 2026 and early 2027, paving the way for a marketing application in that key market.
Looking Ahead: 2026 Guidance and Pipeline Progress
Acadia’s guidance for 2026 DAYBUE net sales ranges from US$460 million to US$490 million, implying Neuren’s royalty income could rise to between A$70 million and A$77 million. This forecast excludes potential European commercial sales, which remain contingent on regulatory outcomes. Beyond DAYBUE, Neuren is advancing its second drug candidate, NNZ-2591, currently in Phase 3 trials targeting multiple neurodevelopmental disorders, including Phelan-McDermid syndrome. Positive clinical data here could further diversify Neuren’s revenue streams and enhance its long-term growth prospects.
Neuren CEO Jon Pilcher emphasised the significance of these developments, stating that the sustained momentum of DAYBUE and expanding patient access are strengthening the company’s financial position and capacity to invest in its pipeline.
Bottom Line?
With DAYBUE’s sales momentum and new formulations, Neuren is well positioned, but regulatory and clinical milestones ahead will be critical to watch.
Questions in the middle?
- Will the CHMP re-examination lead to European approval and commercial sales for DAYBUE?
- How will the new powder formulation impact patient uptake and overall sales growth?
- What are the prospects and timelines for NNZ-2591’s Phase 3 trial results and potential market entry?