Neuren Pharmaceuticals (ASX:NEU) received rare pediatric disease designation from the US Food and Drug Administration for its neurodevelopmental disorder drug candidate, NNZ-2591, in each of Pitt Hopkins syndrome and Angelman syndrome, according to a Monday filing with the Australian bourse.
NNZ-2591 previously received the same designation for Phelan-McDermid syndrome.
The Australian pharmaceutical company said it "may be awarded a priority review voucher (PRV) if the Rare Pediatric Disease PRV program is reauthorized by the US Congress and NNZ-2591 receives marketing authorization for any of these indications."
If awarded, a PRV can be used to obtain a priority review for a different product or sold to another sponsor.
Neuren Pharmaceuticals' shares were up past 6% in recent Monday trade.
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