Acadia Pharmaceuticals Inc. (ACAD) announced that the FDA has approved DAYBUE STIX for oral solution for the treatment of Rett syndrome in adult and pediatric patients two years of age and older
DAYBUE STIX is a dye- and preservative-free powder formulation of trofinetide that caregivers can mix with a variety of water-based liquids, allowing easy adjustment of taste and dose. It provides the same efficacy and safety profile as the original DAYBUE oral solution.
Rett syndrome is a rare neurodevelopmental disorder that affects approximately 6,000 to 9,000 patients in the U.S., typically caused by mutations in the MECP2 gene. Children often experience normal early development before regressing in communication and motor skills, with lifelong care required.
The FDA approval was supported by bioequivalence data showing comparable exposure between DAYBUE STIX and DAYBUE, as well as efficacy and safety results from the Phase 3 LAVENDER study. Patients treated with DAYBUE demonstrated meaningful reductions in Rett syndrome symptoms compared to placebo.
Safety data indicated that DAYBUE STIX was generally well tolerated.
DAYBUE STIX will be available on a limited basis in Q1 2026, with broader availability expected early in Q2 2026. The original oral solution formulation will remain on the market.
DAYBUE delivered $101.1 million in Q3 2025 revenue, up 11% year-over-year.
ACAD has traded between $13.40 and $27.73 over the past year. The stock is currently trading at $26.75, up 0.26%.
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