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Neuren Pharmaceuticals Receives FDA Fast Track for NNZ-2591 in Phelan-McDermid Syndrome

Story Highlights
  • Neuren Pharmaceuticals focuses on developing treatments for serious neurological disorders.
  • FDA grants Fast Track for NNZ-2591, expediting its review for Phelan-McDermid syndrome.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Neuren Pharmaceuticals Receives FDA Fast Track for NNZ-2591 in Phelan-McDermid Syndrome

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Neuren Pharmaceuticals Limited ( (AU:NEU) ) just unveiled an update.

Neuren Pharmaceuticals announced that the FDA has granted Fast Track designation for NNZ-2591 for treating Phelan-McDermid syndrome (PMS), a condition with no current FDA-approved treatments. This designation aims to expedite the drug’s development and review process, highlighting the urgent unmet medical need for PMS therapies. The company is conducting a Phase 3 clinical trial, marking the first of its kind for PMS, which could significantly impact the community affected by this syndrome. Fast Track status has also been granted for NNZ-2591 in Angelman syndrome, enhancing Neuren’s positioning in the neurodevelopmental disorder treatment market.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$21.20 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 focused on developing drug therapies for serious neurological disorders that emerge in early childhood, which have limited or no approved treatment options. The company has developed DAYBUE™ (trofinetide), approved for Rett syndrome, and is working on NNZ-2591 for various neurodevelopmental disorders, including Phelan-McDermid syndrome, Pitt Hopkins syndrome, and Angelman syndrome.

YTD Price Performance: 65.20%

Average Trading Volume: 548,381

Technical Sentiment Signal: Buy

Current Market Cap: A$2.61B

For an in-depth examination of NEU stock, go to TipRanks’ Overview page.

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