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Denali Therapeutics Sells Rare Pediatric Disease Voucher for $195 Million

Denali Therapeutics said June 18 it entered into a definitive agreement to sell its rare pediatric disease priority review voucher for gross proceeds of $195 million.

The voucher was awarded after the FDA’s accelerated approval in March 2026 of Avlayah, Denali’s enzyme replacement therapy for Hunter syndrome. Denali said the sale will add cash to support its TransportVehicle-enabled pipeline across lysosomal storage disorders and neurodegenerative diseases.

The company highlighted a broad slate of programs that could benefit from the proceeds. Its clinical-stage portfolio includes DNL126 for Sanfilippo syndrome type A, DNL593 for GRN-related frontotemporal dementia, DNL952 for Pompe disease and DNL628 for Alzheimer’s disease.

Denali also listed several programs in IND-enabling development: DNL921 for Alzheimer’s disease, DNL111 for Parkinson’s disease and Gaucher disease, DNL622 for Hurler syndrome and DNL422 for Parkinson’s disease.

The voucher transaction remains subject to customary closing conditions, including the expiration of the Hart-Scott-Rodino waiting period. As a result of these announcements, the company's shares have moved 0.19% on the market, and are now trading at a price of $23.535. For more information, read the company's full 8-K submission here.

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