Denali Therapeutics to Sell Rare Pediatric Disease Priority Review Voucher for $195 Million
On June 12, 2026, Denali Therapeutics Inc. entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $195 million in cash. The PRV was originally awarded to Denali by the FDA in March 2026 following the accelerated approval of AVLAYAH (tividenofusp alfa) for the treatment of Hunter syndrome (MPS II). AVLAYAH is notable as the first FDA-approved biologic designed to cross the blood-brain barrier using Denali's proprietary TransportVehicle (TV) platform. The company intends to use the $195 million in gross proceeds to strengthen its financial position and accelerate its clinical pipeline. Key programs targeted for advancement include Enzyme TransportVehicle treatments for lysosomal storage disorders and Oligonucleotide and Antibody TransportVehicle programs for Alzheimerβs and other neurodegenerative diseases. The transaction is subject to customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Denali issued a press release regarding the sale on June 18, 2026.