Neuren Pharmaceuticals (ASX:NEU) has secured another significant regulatory milestone in its Rett syndrome program, announcing that partner Acadia Pharmaceuticals has received U.S. FDA approval for DAYBUE STIX, a new dye- and preservative-free powder formulation of trofinetide for oral solution.
Neuren wins second FDA approval for trofinetide with launch of formulation
December 15, 2025 Australian Biotech
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