Neuren Pharmaceuticals Q3 2025: Record DAYBUE sales fuel robust growth

Neuren Pharmaceuticals reported record DAYBUE sales and royalties in Q3 2025, with expanding US and international demand.

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Key points

  • Neuren Pharmaceuticals reported record Q3 2025 DAYBUE sales of US$101.1 million, with royalty income up by 24% year-on-year.
  • The company's US partner, Acadia Pharmaceuticals, forecasts significant sales growth, with potential for higher royalties as US penetration is below 50%.
  • Neuren is expanding globally with key European regulatory opinions and ongoing clinical trials for its second drug candidate, NNZ-2591.

The Neuren Pharmaceuticals Ltd (ASX: NEU) share price is in focus today after the company reported record Q3 2025 DAYBUE net sales of US$101.1 million, up 11% from a year earlier, and royalty income of A$16.4 million, up 24% year-on-year.

What did Neuren Pharmaceuticals report?

  • Q3 2025 DAYBUE™ (trofinetide) net sales rose 11% to US$101.1 million from Q3 2024, and 5% quarter-on-quarter.
  • Royalty income to Neuren was A$16.4 million, up 24% on Q3 2024 and 12% on Q2 2025.
  • More than 1,000 patients received DAYBUE shipments in Q3, the first time passing this milestone.
  • 74% of new patient prescriptions came from community physicians rather than specialist centres.
  • Forecast full-year 2025 US royalty income is A$63–66 million based on updated Acadia sales guidance.
  • Named patient supply programs are active across Europe, the Middle East, Israel, and Latin America.

What else do investors need to know?

Acadia Pharmaceuticals, Neuren's US partner, refined its DAYBUE US net sales guidance for 2025 to US$385–400 million. This points to ongoing sales growth and higher royalty flow to Neuren if targets are met.

In the US, penetration remains under 50%, leaving room for further expansion. The majority of new DAYBUE users are coming from community physicians, highlighting broadening demand beyond specialist clinics.

Europe remains a focus, with a regulatory opinion expected in Q1 2026. In Japan, a Phase 3 trial is underway, setting the groundwork for future market entries.

What's next for Neuren Pharmaceuticals?

Looking ahead, Neuren will benefit from growing DAYBUE sales and royalties as market penetration increases, particularly in the US community setting. Key catalysts include the awaited European regulatory opinion and ongoing expansion of named patient supply programs.

Neuren is also progressing NNZ-2591, its second drug candidate, in multiple clinical trials for other rare neurological conditions. Each program has earned "orphan drug" designation in both the US and EU, supporting future therapy development.

Neuren Pharmaceuticals share price snapshot

Neuren Pharmaceuticals share price has risen 47% over the past 12 months, significantly outperforming the S&P/ASX 200 Index (ASX: XJO) which has risen 7% over the same period.

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Motley Fool contributor Laura Stewart has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips. This article was prepared with the assistance of Large Language Model (LLM) tools for the initial summary of the company announcement. Any content assisted by AI is subject to our robust human-in-the-loop quality control framework, involving thorough review, substantial editing, and fact-checking by our experienced writers and editors holding appropriate credentials. The Motley Fool Australia stands behind the work of our editorial team and takes ultimate responsibility for the content published by The Motley Fool Australia.

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