DealsJun 18, 2026, 08:02 AM
Denali Sells Priority Review Voucher for $195M
AI Summary
Denali Therapeutics Inc. announced a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $195 million. The PRV was awarded by the FDA in March 2026 following the accelerated approval of AVLAYAH , the first FDA-approved biologic specifically designed to cross the blood-brain barrier. The company stated that these proceeds will strengthen its financial flexibility and accelerate the advancement of its broad clinical pipeline for lysosomal storage disorders and neurodegenerative diseases.
Key Highlights
- Denali sold its Rare Pediatric Disease Priority Review Voucher for $195 million.
- The PRV was awarded following FDA accelerated approval of AVLAYAH in March 2026.
- AVLAYAH is the first FDA-approved biologic designed to cross the blood-brain barrier.
- TransportVehicle platform shows 10-30x greater brain exposure for antibodies/enzymes.
- Oligonucleotides with TV platform demonstrate over 1,000x greater brain exposure in primates.
Price Impact
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