Denali has entered a $275 million royalty funding agreement with Royalty Pharma, linked to future net sales of its lead investigational therapy, tividenofusp alfa, intended to treat Hunter syndrome, a rare genetic disorder affecting boys. The agreement positions Denali to advance its TransportVehicle-enabled enzyme replacement platform while preparing for a potential commercial launch.

Under the terms, Royalty Pharma will make an upfront payment of $200 million, with an additional $75 million contingent on European Medicines Agency approval by 31 December 2029. In return, Royalty Pharma will receive a 9.25% royalty on global net sales until a three-times return is reached, or 2.5-times if achieved by the first quarter of 2039. Completion of the agreement is contingent on several closing conditions, including accelerated approval of tividenofusp alfa by the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) decision expected by 5 April 2026.

Denali CEO Ryan Watts highlighted that the partnership reflects confidence in the therapy’s potential for the Hunter community and supports broader development across the TransportVehicle platform. Royalty Pharma board chairman and CEO Pablo Legorreta emphasised the therapy’s potential to transform patient outcomes by addressing both cognitive and physical manifestations of Hunter syndrome.

The agreement underscores the growing role of innovative funding structures in advancing therapies for rare diseases, enabling companies to accelerate development while mitigating financial risk. Legal advisory support was provided by Maiwald and Goodwin Procter for Royalty Pharma and Gibson Dunn for Denali.

Discover the full article to understand how this royalty funding deal could reshape rare disease therapy development and the future of Denali’s pipeline.