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.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.