Denali Monetizes FDA Voucher For $195M
(RTTNews) - Denali Therapeutics Inc. (DNLI) has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher for $195 million. The voucher was granted by the U.S. FDA in May 2026 following approval of AVLAYAH (tividenofusp alfa-eknm), the first therapy to cross the blood-brain barrier for the treatment of Hunter syndrome.
The company stated that proceeds from the sale will strengthen its balance sheet and support continued investment in its pipeline of therapies for neurodegenerative and lysosomal storage diseases. Denali emphasized that the transaction aligns with its strategy to advance innovative programs while maintaining financial flexibility.
The PRV sale is subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott Rodino Antitrust Improvements Act.
DNLI has traded between $12.58 and $24.20 over the past year. The stock closed Wednesday's trading at $23.49, up 7.11%. In pre-market trading the stock is at $23.78, up 1.24%.
