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.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。