Fast Track granted by FDA for NNZ-2591 in Phelan-McDermid
Filed with ASX · · 2 pages · English
Neuren Pharmaceuticals Limited on 6ix
Story so far
Earlier from Neuren Pharmaceuticals
- Half Yearly Report and Accounts
- First site initiated for Neuren's PMS Phase 3 trial
- Neuren adds SYNGAP1-related disorder to NNZ-2591 pipeline
- DAYBUE Q2 2025 net sales US$96.1 million up 14% from Q2 2024
- US patent allowed for NNZ-2591 to treat Pitt Hopkins
Later from Neuren Pharmaceuticals
- Record DAYBUE net sales of US$101.1 million in Q3 2025
- FDA approves DAYBUE STIX (trofinetide), powder formulation
- DAYBUE net sales projected to reach approx US$700m in 2028
- Response to ASX Aware Letter
- Acadia provides update on EU regulatory submission
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