Neuren receives proceeds from priority review voucher
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The news: Neuren Pharmaceuticals has announced it has received its share of the net proceeds from the sale of the Rare Pediatric Disease Priority Review Voucher (PRV).
The numbers: Neuren will receive, in cash, a one-third share of the USD150 million ($238.6 million) sale and its partner Acadia Pharmaceuticals will receive the remaining.
Neuren shares were up 0.36% to $13.98 by 12:03pm AEDT but over the last 12 months has plunged 38.9%.
The context: The PRV was granted by the US Food and Drug Administration (FDA) last year following the approval of its Daybue drug for the treatment of Rett syndrome.
Neuren also announced that the FDA has granted a Type C meeting in April to discuss the efficacy endpoints in its Phase 3 clinical trial drug NNZ-2591 to treat Phelan-McDermid syndrome.
A Type C meeting looks at the development and review of a product.
Phelan-McDermid syndrome can cause intellectual disability, delayed or absent speech, symptoms of autism, low muscle tone, motor delays, and epilepsy due to a genetic mutation.
What they said: Neuren chief executive Jon Pilcher said: “We look forward to another constructive discussion with FDA. Having a confirmed Type C meeting now establishes a clear timetable and in parallel we are continuing all our preparations, planning for mid-year commencement of the first ever Phase 3 trial for children with Phelan-McDermid syndrome.”
The sources: ASX announcement, ASX announcement
