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Neuren Pharmaceuticals LimitedASX: NEU

Prader-Willi syndrome IND for NNZ-2591 approved by FDA

Jan 22, 2023 at 10:52 PM EST · Issued by Neuren Pharmaceuticals Limited

Filed with ASX · Jan 22, 2023 at 10:52 PM EST · 2 pages · English

On 6ix: 6ix.com/news/prader-willi-syndrome-ind-for-nnz-2591-approved-by-fda

Neuren Pharmaceuticals Limited on 6ix

Story so far

  • Rett Syndrome NDA accepted for Priority Review by FDASep 13, 2022
  • Acadia submits Rett Syndrome New Drug Application to the FDAJul 19, 2022
  • FDA approval for Pitt Hopkins syndrome IND and Phase 2 trialMar 25, 2022

Earlier from Neuren Pharmaceuticals

  • Neuren submits IND & first patients complete Phase 2 trialsDec 22, 2022
  • Q3 2022 quarterly activity and cash flow reportOct 26, 2022
  • Neuren receives US$10 million milestone paymentOct 19, 2022
  • Rett Syndrome NDA accepted for Priority Review by FDASep 12, 2022
  • S&P DJI Announces September 2022 Quarterly RebalanceSep 2, 2022

Later from Neuren Pharmaceuticals

  • Q4 2022 quarterly activity and cash flow reportJan 30, 2023
  • Appendix 4E and 2022 full year accountsFeb 23, 2023
  • Neuren reports 2022 full-year resultsFeb 23, 2023
  • FDA approves Daybue - the first treatment for Rett syndromeMar 12, 2023
  • DAYBUE (trofinetide) launched in US - Neuren earns US$40mApr 18, 2023
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