FDA approves DAYBUE STIX (trofinetide), powder formulation
| Stock | Neuren Pharmaceuticals Ltd (NEU.ASX) |
|---|---|
| Release Time | 15 Dec 2025, 9:05 a.m. |
| Price Sensitive | Yes |
FDA approves DAYBUE STIX, new powder formulation for Rett syndrome
- DAYBUE STIX is a new dye- and preservative-free powder formulation of trofinetide
- DAYBUE STIX provides Rett syndrome patients and caregivers with new flexibility and choice
- DAYBUE and DAYBUE STIX are the only US FDA-approved treatments for Rett syndrome
Neuren Pharmaceuticals (ASX: NEU) announced that its partner, Acadia Pharmaceuticals (Nasdaq: ACAD), has received US Food and Drug Administration (FDA) approval of DAYBUE® STIX (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. The new powder formulation offers children and adults living with Rett syndrome new flexibility and choice regarding the dose volume and taste of their DAYBUE treatment. The approval of this new formulation was informed by the results of a bioequivalence study, which demonstrated that both original DAYBUE (trofonetide) oral solution and the new DAYBUE STIX (trofinetide) for oral solution powder formulation provide comparable exposure. Acadia expects DAYBUE STIX to be available on a limited basis starting in the first quarter of 2026 and more broadly early in the second quarter of 2026. The current oral solution formulation will remain available.
Neuren has granted an exclusive worldwide licence to Acadia Pharmaceuticals Inc. for the development and commercialisation of trofinetide. Neuren receives royalties on all net sales of trofinetide and is eligible to receive additional payments on achievement of commercial and development milestones.