Denali Therapeutics Sells Rare Pediatric Disease PRV for $195M
Denali Therapeutics announced it has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher, PRV, for gross proceeds of $195M. The U.S. Food and Drug Administration, FDA, awarded the PRV to Denali following accelerated approval of the enzyme replacement therapy Avlayah for the treatment of Hunter syndrome in March 2026. Avlayah is the first FDA-approved medicine in an emerging class of biotherapeutics designed to cross the blood-brain barrier via transferrin receptor-mediated transport.
