Denali has entered a $275m royalty funding agreement with Royalty Pharma based on future net sales of tividenofusp alfa therapy.

Denali’s lead investigational TransportVehicle-enabled enzyme replacement therapy is intended to treat mucopolysaccharidosis type II (Hunter syndrome, a rare genetic disorder affecting boys).

The US Food and Drug Administration (FDA) is currently evaluating a biologics licence application (BLA) seeking accelerated approval for tividenofusp alfa, with a Prescription Drug User Fee Act (PDUFA) decision expected by 5 April 2026.

Completion of the agreement remains contingent on several closing conditions, including the granting of accelerated approval by the FDA.

Denali CEO Ryan Watts stated: “We are pleased to partner with Royalty Pharma, whose investment recognises the value and potential of tividenofusp alfa for the Hunter community and supports our ability more broadly to realise the promise of the TransportVehicle platform.

“With these additional funds, we are well positioned to advance our development programmes as we prepare for the launch of tividenofusp alfa, unlocking broad opportunities across serious diseases.”

Upon closure, Royalty Pharma is set to make an upfront payment of $200m. An additional $75m payment will be made if tividenofusp alfa receives approval from the European Medicines Agency by 31 December 2029.

In exchange, the company will be entitled to a 9.25% royalty on global net sales of the therapy. These payments will conclude once a three times return is reached, or 2.5 times if achieved by the first quarter of 2039.

Royalty Pharma board chairman and CEO Pablo Legorreta stated: “We are delighted to partner with Denali and acquire a royalty on tividenofusp alfa, an innovative therapy that addresses a significant unmet need in the cognitive and physical manifestations of Hunter syndrome.

“Denali’s technology platform delivers therapeutics across the blood-brain barrier and is a promising new approach to brain diseases. We are thrilled to establish a relationship with Denali and believe tividenofusp alfa is a potential practice-changing therapy that could transform the lives of patients with Hunter syndrome.”

Maiwald and Goodwin Procter served as legal advisors to Royalty Pharma while Gibson Dunn is Denali’s legal advisor.