Denali Therapeutics Enters Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $195 Million

Denali Therapeutics announced it will sell its Rare Pediatric Disease Priority Review Voucher for $195 million following FDA approval of AVLAYAH, the first FDA-approved biologic designed to cross the blood-brain barrier. The proceeds will support advancement of Denali's clinical pipeline for lysosomal storage disorders and neurodegenerative diseases. However, the article also notes that Biogen and Denali's Phase 2b LUMA study of BIIB122 in early-stage Parkinson's disease failed to meet its primary and secondary endpoints, leading to discontinuation of the program.