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Healthcare

Denali Therapeutics Inc.

07/28/2026 | Press release | Distributed by Public on 07/28/2026 04:04

Asset Transaction (Form 8-K)

Item 2.01 Completion of Acquisition or Disposition of Assets.

On July 27, 2026, Denali Therapeutics Inc. (the "Company") completed the previously disclosed sale (the "Sale") of its Rare Pediatric Disease Priority Review Voucher (the "PRV") to a large pharmaceutical company. The Company received the PRV when AVLAYAHTM (tividenofusp alfa) was approved by the U.S. Food and Drug Administration for the treatment of Hunter syndrome (mucopolysaccharidosis type II; MPS II) in March 2026. The Sale was completed pursuant to the terms of an asset purchase agreement, dated June 12, 2026 (the "PRV Transfer Agreement"). Pursuant to the PRV Transfer Agreement, the Company received gross proceeds of $195.0 million from the buyer upon the closing of the Sale.

The foregoing description of the PRV Transfer Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Transfer Agreement, which will be filed as an exhibit to a subsequent filing with the Securities and Exchange Commission.

Denali Therapeutics Inc. published this content on July 28, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on July 28, 2026 at 10:04 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]