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Neuren Pharmaceuticals LimitedASX: NEU

NEU continues PMS P3 preparations after positive FDA meeting

Oct 6, 2024 at 10:53 PM EDT · Issued by Neuren Pharmaceuticals Limited

Filed with ASX · Oct 6, 2024 at 10:53 PM EDT · 3 pages · English

On 6ix: 6ix.com/news/neu-continues-pms-p3-preparations-after-positive-fda-meeting

Neuren Pharmaceuticals Limited on 6ix

Story so far

  • FDA approves Daybue - the first treatment for Rett syndromeMar 13, 2023
  • Prader-Willi syndrome IND for NNZ-2591 approved by FDAJan 23, 2023
  • Rett Syndrome NDA accepted for Priority Review by FDASep 13, 2022

Earlier from Neuren Pharmaceuticals

  • Phase 2 trial shows significant improvements in AngelmanAug 9, 2024
  • Q2 2024 updateAug 7, 2024
  • Phase 2 trial shows significant improvements in Pitt HopkinsMay 27, 2024
  • DAYBUE Q1 net sales US$75.9m, full-year guidance US$370-420mMay 9, 2024
  • Q1 2024 quarterly activity and cash flow reportApr 24, 2024

Later from Neuren Pharmaceuticals

  • DAYBUE receives marketing authorization in CanadaOct 16, 2024
  • PRV sold for US$150m - Neuren to receive one thirdNov 5, 2024
  • Q3 2024 updateNov 6, 2024
  • Neuren announces A$50m on-market share buy-back programNov 13, 2024
  • Trofinetide marketing application submitted in EuropeJan 14, 2025
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