Neuren Pharmaceuticals Advances Phase 3 Trial for Phelan-McDermid Syndrome

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

Neuren Pharmaceuticals has confirmed receipt of FDA minutes from a Type C Meeting, reaffirming the primary endpoints for its Phase 3 trial of NNZ-2591 to treat Phelan-McDermid syndrome. The trial will focus on changes in communication abilities and overall syndrome assessment, with previous Phase 2 trials showing significant improvements. The company is set to begin the Phase 3 trial mid-2025, with no need for additional funding, highlighting its strong financial position. This development underscores Neuren’s commitment to addressing unmet medical needs in neurodevelopmental disorders, potentially strengthening its position in the pharmaceutical industry.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$30.65 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 engaged in developing new drug therapies for serious neurological disorders that manifest in early childhood and have limited or no approved treatment options. The company has received ‘orphan drug’ designation in the United States for its programs, which provides incentives for developing therapies for rare and serious diseases. Neuren’s drug DAYBUE™ (trofinetide) is approved for treating Rett syndrome, and they have licensed it to Acadia Pharmaceuticals Inc. for global development and commercialization. Their second drug candidate, NNZ-2591, is in development for multiple neurodevelopmental disorders, with positive Phase 2 trial results.

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