Neuren’s Royalties at Stake as FDA Approves New DAYBUE STIX Rett Syndrome Treatment
Neuren Pharmaceuticals’ partner Acadia secures FDA approval for DAYBUE STIX, a new powder formulation of trofinetide offering greater flexibility for Rett syndrome patients. This milestone expands treatment options and sets the stage for increased royalty revenue in 2026.
- FDA approves DAYBUE STIX, a dye- and preservative-free powder formulation
- DAYBUE STIX offers flexible dosing and taste options for Rett syndrome patients
- Both DAYBUE and DAYBUE STIX are the only FDA-approved Rett syndrome treatments
- Neuren to receive royalties on net sales and potential milestone payments
- DAYBUE STIX expected to launch broadly in Q2 2026 alongside existing oral solution
New Formulation Approved for Rett Syndrome
Neuren Pharmaceuticals (ASX – NEU) has announced a significant regulatory milestone as its partner Acadia Pharmaceuticals (Nasdaq – ACAD) received US FDA approval for DAYBUE STIX, a new powder formulation of trofinetide designed for oral solution. This formulation is dye- and preservative-free, providing a fresh option for patients with Rett syndrome, a rare neurological disorder primarily affecting young children.
The approval covers patients aged two years and older, expanding the treatment’s accessibility. Unlike the original liquid oral solution, DAYBUE STIX can be mixed with various water-based liquids, allowing caregivers to tailor the taste and volume to better suit individual patient needs. This flexibility could improve adherence and quality of life for both patients and their families.
Bioequivalence and Market Availability
Crucially, a bioequivalence study confirmed that the new powder formulation delivers comparable exposure to the original DAYBUE oral solution, ensuring consistent efficacy and safety. This regulatory confidence supports the interchangeable use of the two formulations without compromising treatment outcomes.
Acadia plans a phased rollout, with limited availability starting in the first quarter of 2026 and broader distribution expected by the second quarter. The original oral solution will remain on the market, giving patients and caregivers a choice between formulations.
Commercial and Strategic Implications for Neuren
For Neuren, this approval represents a meaningful commercial opportunity. The company receives royalties on net sales of trofinetide worldwide and is positioned to benefit from additional milestone payments tied to development and commercial progress. Given that DAYBUE and DAYBUE STIX are currently the only FDA-approved treatments for Rett syndrome, the expanded product offering could drive greater market penetration and revenue growth.
Neuren’s CEO Jon Pilcher expressed optimism about the approval, highlighting the innovation and patient-centric approach of the new formulation. The company’s broader pipeline, including NNZ-2591 for other neurodevelopmental disorders, also remains a focus, with ongoing clinical progress underscoring Neuren’s commitment to addressing rare neurological diseases.
Looking Ahead
As DAYBUE STIX enters the market, investors and stakeholders will be watching closely to gauge uptake and sales momentum. The new formulation’s convenience and patient-friendly features could be key drivers in expanding the treatment’s footprint in the Rett syndrome community.
Bottom Line?
DAYBUE STIX’s FDA approval opens a new chapter for Neuren, with 2026 set to reveal its commercial impact.
Questions in the middle?
- How quickly will DAYBUE STIX gain market share relative to the original oral solution?
- What are the projected royalty revenue increases for Neuren from the new formulation?
- Will further formulation innovations or indications for trofinetide emerge in the near term?
