Priority Review Voucher sale proceeds received

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Stock Neuren Pharmaceuticals Ltd (NEU.ASX)
Release Time 7 Feb 2025, 12:03 p.m.
Price Sensitive Yes
 Neuren Receives Priority Review Voucher Sale Proceeds
Key Points
  • Neuren received one-third share of net proceeds from sale of Rare Pediatric Disease Priority Review Voucher
  • Voucher was granted to Neuren's partner Acadia Pharmaceuticals following FDA approval of DAYBUETM (trofinetide) for Rett syndrome
  • Neuren has granted Acadia an exclusive worldwide license for the development and commercialization of trofinetide
Full Summary

Neuren Pharmaceuticals (ASX: NEU) has announced that it has received in cash its one-third share of the net proceeds from the sale of the Rare Pediatric Disease Priority Review Voucher (PRV). The PRV was granted to Neuren's partner Acadia Pharmaceuticals (NASDAQ: ACAD) by the U.S. Food and Drug Administration (FDA) following the approval of DAYBUETM (trofinetide) for the treatment of Rett syndrome. Acadia successfully completed the sale of the PRV for US$150 million on 11 December 2024. Under the license agreement between Neuren and Acadia, Neuren receives one-third of the proceeds, net of any applicable costs. Neuren is developing new drug therapies to treat multiple serious neurological disorders that emerge in early childhood and have no or limited approved treatment options. Recognizing the urgent unmet need, all of Neuren's programs have been granted 'orphan drug' designation in the United States, which provides incentives to encourage the development of therapies for rare and serious diseases. DAYBUETM (trofinetide) is approved by the FDA and Health Canada for the treatment of Rett syndrome, and Neuren has granted an exclusive worldwide license to Acadia Pharmaceuticals for the development and commercialization of trofinetide. Neuren's second drug candidate, NNZ-2591, is in development for multiple neurodevelopmental disorders, with positive results achieved in Phase 2 clinical trials in Phelan-McDermid syndrome, Pitt Hopkins syndrome, and Angelman syndrome.