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Neuren Pharmaceuticals Limited (ASX:NEU)

ALERT: Price-sensitive ASX Announcement for NEU
Current share price for NEU : $16.340 -2.67 (-14.05%)+
Announcement
Release
15 Dec 2025 9:05AM
Price at Release
$19.010
Full Release
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Summary
Neuren Pharmaceuticals Limited announced that the US FDA has approved DAYBUE STIX (trofinetide) for oral solution, a new powder formulation designed for the treatment of Rett syndrome in patients aged two years and older. This approval provides a new flexible option for patients and caregivers, allowing mixture with various liquids to modify taste and dosage volume. Neuren Pharmaceuticals will receive royalties from the net sales of trofinetide, which is developed and commercialized under an exclusive worldwide license by Acadia Pharmaceuticals. The DAYBUE STIX formulation was approved based on bioequivalence studies demonstrating comparable exposure to the original DAYBUE oral solution. Availability is expected to begin on a limited basis in early 2026, with broader availability by the second quarter of 2026.
Key Points
  • FDA approved DAYBUE STIX, a new powder formulation of trofinetide.
  • DAYBUE STIX is designed for Rett syndrome patients aged two years and older.
  • The new formulation offers flexible dosing options by mixing with liquids.
  • Neuren Pharmaceuticals will receive royalties from the sales.
  • Approval was based on bioequivalence with the original DAYBUE oral solution.
  • DAYBUE STIX expected to be available in early 2026.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.