Neuren Pharmaceuticals shares rocket on FDA fast track review
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The news: Neuren Pharmaceuticals was the top performing ASX 200 stock in morning trade, after the US Food and Drug Administration (FDA) grated fast track designation for the biotech's drug NNZ-2591 for the treatment of Phelan-McDermid syndrome (PMS).
The numbers: Neuren shares were up 8.8% to $22.46 at 11:10am AEDT. The stock is up 71% over the last 12 months.
The context: Neuren recently initiated its Phase 3 clinical trial, "Koala", to evaluate NNZ-2591 in children aged three to 12 years with PMS. The company said it has reached alignment with the FDA on the single Phase 3 trial and endpoints to support a new drug application.
The FDA's fast track designation is a process signed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Neuren has also been granted the fast track designation for NNZ-2591 in Angelman syndrome and Pitt Hopkins syndrome.
What they said: "Neuren's Koala trial is the first ever Phase 3 clinical trial for PMS, which we hope may lead to a much-needed treatment for this community," said CEO Jon Pilcher.
The source: ASX
