Neuren Pharmaceuticals (ASX:NEU) said the US Congress on Tuesday reauthorized the Rare Pediatric Disease Priority Review Voucher (PRV) program, extending it through Sept. 30, 2029, according to a Thursday Australian bourse filing.
The PRV program grants a voucher to developers whose drug receives approval from the US Food and Drug Administration (FDA) for a designated rare pediatric disease, which can be used for priority review of another drug or be sold or transferred, per the filing.
The company's NNZ-2591 has rare pediatric disease designations for Phelan-McDermid, Pitt Hopkins, and Angelman syndromes, and US FDA approval in any of these would earn a voucher, with full ownership and entitlement to all sale proceeds, the filing said.