FDA cleared Avlayah for Hunter syndrome in March 2026, and Denali Therapeutics has now converted that milestone into $195 million, selling the priority review voucher that came with it.
The deal, announced June 18, leaves the buyer unnamed. It closes once Hart-Scott Rodino antitrust clearance comes through. The $195 million lands above the recent going rate: Zevra Therapeutics sold one for $150 million last year after Miplyffa, and Jazz pulled $200 million in January as the Senate debated whether to renew the PRV program, which had lapsed in December 2024.
Avlayah, tividenofusp alfa-eknm, is the first new treatment for Hunter syndrome in 20 years. The disease causes sugar molecules to build up in the body, damaging physical and mental development; patients typically don’t survive past age 20. It’s also the first drug approved using Denali’s TransportVehicle technology, which aids the passage of drugs across the blood-brain barrier.
Denali is routing the $195 million into that platform. The pipeline includes DNL126 for Sanfilippo syndrome type A, DNL593 for GRN-related frontotemporal dementia, DNL952 for Pompe disease, and DNL628 for Alzheimer’s disease.
PRV values have swung hard. The program launched in 2014 with vouchers fetching up to $350 million, compressed to roughly $150 million in recent years, and lapsed entirely in December 2024 before Congress reauthorized it in February. Jazz’s $200 million in January reflected uncertainty around renewal. Denali’s $195 million, cleared under the restored program, suggests the market is recalibrating upward.
Deal closes pending antitrust clearance.
— Sarah Chen