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Neuren Pharmaceuticals Faces Delay in FDA Meeting for NNZ-2591

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Neuren Pharmaceuticals Faces Delay in FDA Meeting for NNZ-2591

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Neuren Pharmaceuticals Limited ( (AU:NEU) ) has shared an update.

Neuren Pharmaceuticals announced a one-month administrative delay in the FDA’s pre-IND meeting for their drug candidate NNZ-2591, now rescheduled for late January 2026. This delay may impact the timeline for developing treatments for hypoxic ischemic encephalopathy (HIE), highlighting the challenges in advancing therapies for rare neurological disorders.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$23.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.

More about Neuren Pharmaceuticals Limited

Neuren Pharmaceuticals is a company focused on developing new drug therapies for serious neurological disorders that emerge in early childhood and have limited or no approved treatment options. The company has developed DAYBUE™ (trofinetide), approved for the treatment of Rett syndrome, and has licensed it to Acadia Pharmaceuticals Inc. Neuren’s second drug candidate, NNZ-2591, is being developed for multiple neurodevelopmental disorders and has received orphan drug designation in the US and EU.

Average Trading Volume: 450,817

Technical Sentiment Signal: Buy

Current Market Cap: A$2.5B

See more insights into NEU stock on TipRanks’ Stock Analysis page.

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