Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.
Denali Therapeutics has sold a priority review voucher for $195 million, marking a rise in value for the coveted regulatory fast passes.
Denali snagged the ticket from the approval of rare disease drug Avlayah in March 2026. The drug was cleared by the FDA for use in patients with Hunter syndrome. The buyer was not disclosed in Denali’s June 18 announcement.
The biotech intends to use the proceeds from the sale to support a pipeline of assets generated using its TransportVehicle technology, which aids the passage of drugs across the blood-brain barrier. Denali is developing therapies for lysosomal storage disorders and neurodegenerative diseases.
The FDA awards priority review vouchers (PRVs) upon approval of a drug that has been granted a rare pediatric disease tag. Companies can either use them for a speedy approval of another drug or sell them, generating non-dilutive capital.
When the program began in 2014, the passes sold for as high as $350 million. More recently, the going rate has been $150 million. Zevra Therapeutics sold one last year for that much after the approval of Miplyffa. But Jazz received $200 million for one in January this year as the Senate debated renewal of the priority review program, which lapsed in December 2024.
After months of delay, the rare pediatric disease priority review program was in fact renewed in February.
Avlayah was the first new drug approved for the rare disease Hunter syndrome in 20 years. The disease causes sugar molecules to build up in the body, affecting physical and mental development. Patients typically die by age 20.
With Avlayah approved and the launch underway, Denali is now turning its attention to its remaining pipeline. This includes DNL126 for Sanfilippo syndrome type A, DNL593 for GRN-related frontotemporal dementia, DNL952 for Pompe disease and DNL628 for Alzheimer’s disease, in addition to a clutch of preclinical programs.
