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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 their drug candidate NNZ-2591 for treating Pitt Hopkins syndrome, a serious neurodevelopmental condition with no current approved treatments. This designation is expected to expedite the drug’s development and review process, potentially providing a significant advancement in treatment options for the syndrome. In a Phase 2 clinical trial, NNZ-2591 showed promising results, with 82% of participants experiencing improvements in key developmental areas, which underscores the drug’s potential impact on addressing unmet medical needs.
More about Neuren Pharmaceuticals Limited
Neuren Pharmaceuticals is focused on developing new drug therapies for serious neurological disorders that emerge in early childhood and have limited or no approved treatment options. Their programs are recognized with ‘orphan drug’ designation in the United States to encourage development of therapies for rare diseases. Neuren’s notable product, DAYBUE™ (trofinetide), is approved for treating Rett syndrome, with an exclusive worldwide license granted to Acadia Pharmaceuticals Inc. for its development and commercialization. Neuren’s second drug candidate, NNZ-2591, is being developed for multiple neurodevelopmental disorders.
YTD Price Performance: 6.70%
Average Trading Volume: 807
Technical Sentiment Consensus Rating: Hold
Current Market Cap: $1.1B
Find detailed analytics on NEU stock on TipRanks’ Stock Analysis page.
