Neuren Pharmaceuticals: Receives priority review for trofinetide NDA

Neuren Pharmaceuticals Receives priority review for trofinetide NDA

• Neuren Pharmaceuticals (NEU) receives priority review for a New Drug Application (NDA) of its trofinetide drug for the treatment of Rett syndrome
• The US Food and Drug Administration (FDA) granted the priority review and also assigned a Prescription Drug User Fee Act action date of March 12, 2023
• If the FDA approves the NDA, Neuren expects it will earn revenue of $118 million plus double-digit percentage royalties on net sales between 2022 and 2023 in the US
• Further, NEU will receive milestone payments of US$10 million (A$14.4 million) following the acceptance of the NDA for review by the FDA and A$58 million following the first commercial sale of trofinetide in the US
• Neuren is up 3.85 per cent on the market with shares trading at $6.47 at 11:54 am AEST