Priority Review Voucher sale complete
Released
Released
Announcement PDF
Neuren (NEU) – ASX Announcement
12 December 2024
Priority Review Voucher sale complete
Highlights:
•
Acadia Pharmaceuticals successfully completed the sale of Rare Pediatric Disease Priority Review
Voucher (PRV) for US$150m
•
Neuren to receive one-third of the net proceeds
Melbourne, Australia: Neuren Pharmaceuticals (ASX: NEU) today announced that the sale of the Rare
Pediatric Disease Priority Review Voucher (PRV) by its partner Acadia Pharmaceuticals (NASDAQ: ACAD)
has been successfully completed.
The PRV was granted by the U.S. Food and Drug Administration (FDA) following the approval of
DAYBUETM (trofinetide) for the treatment of Rett syndrome. On 5 November 2024 ET, Acadia announced
the sale of the PRV for US$150m subject to customary closing conditions, including expiration of
applicable waiting period under the Hart-Scott Rodino (HSR) Antitrust Improvements Act. Under the
license agreement between Acadia and Neuren, Neuren is entitled to receive one-third of the proceeds,
net of any applicable costs, which are not expected to be material.
About Neuren
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. Recognising the urgent unmet
need, all programs have been granted “orphan drug” designation in the United States. Orphan drug
designation provides incentives to encourage development of therapies for rare and serious diseases.
DAYBUE™ (trofinetide) is approved by the US Food and Drug Administration (FDA) and Health Canada for
the treatment of Rett syndrome. Neuren has granted an exclusive worldwide licence to Acadia
Pharmaceuticals Inc. for the development and commercialisation of trofinetide.
Neuren’s second drug candidate, NNZ-2591, is in Phase 2 development for multiple neurodevelopmental
disorders, with positive results achieved in Phase 2 clinical trials in Phelan-McDermid syndrome, Pitt
Hopkins syndrome and Angelman syndrome.
Contact:
investorrelations@neurenpharma.com
Jon Pilcher, CEO: +61 438 422 271
ASX Listing Rules information
This announcement was authorized to be given to the ASX by the board of directors of Neuren
Pharmaceuticals Limited, Suite 201, 697 Burke Road, Camberwell, VIC 3124
1 of 2
Forward-looking Statements
This announcement contains forward-looking statements that are subject to risks and uncertainties. Such
statements involve known and unknown risks and important factors that may cause the actual results,
performance or achievements of Neuren to be materially different from the statements in this
announcement.
2 of 2
Share your feedback
Discover