Neuren Hits Record DAYBUE Sales, Royalty Income Surges 24% in Q3 2025
Neuren Pharmaceuticals reported a milestone quarter with DAYBUE net sales reaching US$101.1 million, driving a 24% jump in royalty income. The expanding patient base and community physician uptake signal strong growth ahead.
- Q3 2025 DAYBUE net sales up 11% year-on-year to US$101.1 million
- Neuren's Q3 royalty income rises 24% to A$16.4 million
- Over 1,000 patients treated with DAYBUE for the first time
- 74% of new prescriptions from community physicians outside specialist centers
- Acadia narrows full-year 2025 DAYBUE sales guidance to US$385–400 million
Record Sales and Royalty Growth
Neuren Pharmaceuticals has delivered a standout performance in the third quarter of 2025, with its partner Acadia Pharmaceuticals reporting DAYBUE™ (trofinetide) net sales of US$101.1 million. This represents an 11% increase compared to the same period last year and a 5% rise from the previous quarter. For Neuren, this translated into a 24% jump in royalty income to A$16.4 million, underscoring the growing commercial traction of their flagship Rett syndrome treatment.
Expanding Patient Reach and Community Adoption
Notably, the number of unique patients receiving DAYBUE shipments surpassed 1,000 for the first time, climbing steadily from 954 in Q1 and 987 in Q2. A significant driver of this growth is the shift in prescribing patterns, 74% of new patient prescriptions came from community physicians rather than specialized Rett syndrome centers. This broadening of the prescriber base, supported by Acadia’s expanded field force, has fueled the largest quarter-over-quarter increase in patient referrals since the drug’s launch.
Guidance and Market Potential
Acadia has tightened its full-year 2025 sales guidance for DAYBUE in the US to between US$385 million and US$400 million, slightly narrowing the previous range. This adjustment implies that Neuren’s royalty income for the year could reach between A$63 million and A$66 million, assuming currency exchange rates hold steady. Despite already achieving approximately 40% penetration in the US Rett syndrome patient population, there remains substantial room for growth, particularly as community physician engagement deepens.
Regulatory and Pipeline Developments
Looking beyond the US, Acadia anticipates a Committee for Medicinal Products for Human Use (CHMP) opinion on its marketing application in the European Union during the first quarter of 2026. Meanwhile, a Phase 3 trial has commenced in Japan, and named patient supply programs are active across Europe, Israel, the Middle East, and Latin America, signaling a clear global expansion strategy. Neuren’s pipeline also includes NNZ-2591, a promising candidate targeting multiple neurodevelopmental disorders, which has received orphan drug designations in both the US and EU.
Strategic Outlook
Neuren’s progress with DAYBUE reflects a successful partnership model and a growing footprint in a rare disease market with significant unmet needs. The steady persistency rate above 50% after 12 months of treatment suggests strong patient adherence, an encouraging sign for long-term revenue stability. As regulatory milestones approach and community adoption accelerates, Neuren is well positioned to capitalize on the expanding market opportunity.
Bottom Line?
Neuren’s record quarter and expanding patient base set the stage for sustained growth, but upcoming regulatory decisions will be pivotal.
Questions in the middle?
- Will Acadia’s EU marketing application receive timely CHMP approval in early 2026?
- How will the Phase 3 trial in Japan impact Neuren’s global expansion plans?
- What is the potential market impact of Neuren’s NNZ-2591 in neurodevelopmental disorders?