Key Highlights

  • Neuren (ASX:NEU) reported record Q2 2026 DAYBUE net sales of US$125 million, representing growth of 30% compared with Q2 2025.
  • Quarterly royalty income increased to US$12.9 million, supported by higher DAYBUE sales volumes.
  • Acadia Pharmaceuticals upgraded its 2026 DAYBUE sales guidance to US$480–510 million, increasing Neuren’s expected royalty range.
  • European expansion and a Japanese clinical trial milestone remain key future developments for trofinetide.

Neuren Pharmaceuticals (ASX:NEU) has reported record quarterly sales performance for DAYBUE® (trofinetide), with its commercial partner Acadia Pharmaceuticals achieving US$125 million in net sales during the second quarter of 2026.

The result represents a 30% increase compared with the second quarter of 2025 and a 24% increase from the first quarter of 2026. According to Neuren, the sales increase was primarily driven by higher patient volumes, supported by adoption of the DAYBUE STIX powder formulation in the United States.

The performance has led Acadia to increase its full-year 2026 DAYBUE net sales guidance, with implications for Neuren’s royalty income outlook under its licensing agreement.

DAYBUE STIX Adoption Supports Volume Growth

A key contributor to the latest quarterly performance was continued uptake of DAYBUE STIX, a powder formulation of trofinetide designed to provide an alternative administration format for patients.

The product became broadly available in the United States from early April 2026 following a limited launch through Rett syndrome Centers of Excellence during the first quarter.

By the end of the second quarter, approximately 40% of all U.S. DAYBUE patients were receiving STIX. Around 45% of STIX demand during the quarter came from new or returning patients.

Neuren stated that sales growth was primarily volume-driven, reflecting increased adoption and patient demand rather than pricing factors.

Royalty Income Increases Following Higher Sales Guidance

Neuren earned royalty income of US$12.9 million during Q2 2026, representing a 34% increase compared with Q2 2025 and a 24% increase compared with Q1 2026.

Following the quarterly performance, Acadia increased its full-year 2026 DAYBUE net sales guidance to US$480 million to US$510 million, compared with its previous guidance range of US$460 million to US$490 million.

Based on the revised sales outlook, Neuren expects full-year 2026 royalty income of approximately US$53 million to US$56 million, compared with its previous expectation of US$50 million to US$54 million.

Acadia has also maintained its longer-term target of achieving DAYBUE net sales of US$700 million in 2028.

European Expansion Progresses Toward Potential Launch

Neuren continues to progress international expansion opportunities for trofinetide through its licensing partnership with Acadia Pharmaceuticals.

In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of DAYBUE for the treatment of neurobehavioral symptoms associated with Rett syndrome in adults and children aged five years and older.

If marketing authorisation is granted by the European Commission, the approval would apply across European Union member states as well as Iceland, Liechtenstein and Norway.

Commercial launch in Germany is anticipated in early Q4 2026, subject to regulatory approval.

Under the European licensing agreement, Neuren is eligible to receive a US$35 million payment following the first commercial sale, additional sales milestone payments of up to US$170 million and tiered royalties ranging from the mid-teens to low-20% range of net sales.

Japan Clinical Program Remains on Schedule

Neuren is also progressing the Japanese development pathway for trofinetide.

The company expects topline results from its ongoing Japanese clinical trial between September and November 2026. A regulatory submission in Japan is anticipated during 2027, subject to trial outcomes and regulatory requirements.

Expansion into additional markets remains an important component of the long-term commercial strategy for DAYBUE.

Neuren’s Broader Neurological Development Pipeline

Beyond trofinetide, Neuren continues to develop NNZ-2591 (ercanetide), an oral therapy candidate targeting multiple neurodevelopmental disorders.

NNZ-2591 is currently being evaluated in clinical programs targeting conditions including Phelan-McDermid syndrome, Pitt Hopkins syndrome, Angelman syndrome and hypoxic ischemic encephalopathy.

The candidate has received orphan drug designations in the United States and European Union, alongside Fast Track and Rare Pediatric Disease designations from the U.S. Food and Drug Administration for relevant programs.

Neuren is currently conducting a Phase 3 clinical trial evaluating NNZ-2591 in children aged three to 12 years with Phelan-McDermid syndrome.

Conclusion

Neuren’s latest quarterly update highlights continued commercial progress for DAYBUE, with record sales, increased royalty income and improved full-year guidance from its partner Acadia Pharmaceuticals. The expansion of trofinetide into additional markets, alongside ongoing development of NNZ-2591, supports Neuren’s focus on neurological therapies addressing conditions with limited treatment options.