Denali Therapeutics has sold a priority review voucher for $195 million, according to a June 18 announcement. The company obtained the voucher following the approval of its rare disease drug Avlayah in March for use in patients with Hunter syndrome. The buyer of the voucher was not disclosed.
Denali said it plans to use proceeds from the sale to support its pipeline of assets generated using its TransportVehicle technology, which helps drugs cross the blood-brain barrier. The company is developing therapies targeting lysosomal storage disorders and neurodegenerative diseases.
The U.S. Food and Drug Administration awards priority review vouchers when a drug with a rare pediatric disease designation is approved. These vouchers can be used by companies to expedite regulatory review of another drug or sold to generate non-dilutive capital.
Priority review vouchers have varied in value since their introduction in 2014, initially selling for as much as $350 million. More recently, prices have ranged from $150 million—such as Zevra Therapeutics' sale last year—to $200 million, which Jazz received earlier this year while Congress debated renewal of the program that had lapsed at the end of 2024. After several months without authorization, Congress renewed the rare pediatric disease priority review program in February.
Avlayah represents the first new treatment approved for Hunter syndrome in two decades. The condition leads to accumulation of sugar molecules within cells and affects both physical and mental development; most patients do not live beyond age 20. With Avlayah now launched, Denali's focus shifts to advancing other candidates including DNL126 for Sanfilippo syndrome type A, DNL593 for GRN-related frontotemporal dementia, DNL952 for Pompe disease, DNL628 for Alzheimer's disease, and additional preclinical programs.
