Neuren Pharmaceuticals (ASX:NEU) was granted a type C Meeting with the US Food and Drug Administration to discuss the primary efficacy endpoints of its phase 3 clinical trial program for a neurodevelopmental disorder drug candidate, the company said in a Friday Australian bourse filing.
The drug candidate, NNZ-2591, is in development for multiple neurodevelopmental disorders and achieved positive results in phase 2 clinical trials in Phelan-McDermid syndrome, Pitt-Hopkins syndrome, and Angelman syndrome, per the filing.
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