Neuren shares climb on fresh FDA designation
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The news: Neuren Pharmaceuticals was among the best-performing ASX 200 stocks in morning trade after securing a rare pediatric disease designation from the US Food and Drug Administration (FDA) for a trial-phase treatment targeting Pitt Hopkins syndrome and Angelman syndrome.
The numbers: Neuren shares were up 6.3% to $14.10 at 11:25am AEDT. They closed 2.6% higher last Wednesday after the FDA granted a fast track designation for the same treatment.
The context: Neuren said that the designation could lead to the award of a priority review voucher (PRV) if the rare pediatric disease PRV program is reauthorised by the US congress, and if the treatment receives marketing authorisation for any of its applications.
Neuren also previously received a rare pediatric disease designation from the FDA for the same drug to treat Phelan-McDermid syndrome.
The PRV program is designed to encourage drug development for serious rare pediatric diseases. If awarded, a PRV can be redeemed for priority review of another product or sold to another sponsor.
Neuren’s partner, Acadia Pharmaceuticals, previously secured a PRV for its Rett syndrome treatment, trofinetide, and later sold it for USD150 million ($235 million).
The source: ASX
