Denali clinches $275 million royalty deal to power potential breakthrough Hunter Syndrome therapy

Denali Therapeutics has secured a major cash infusion, unveiling a $275 million synthetic royalty deal with Royalty Pharma tied to future global sales of its experimental Hunter syndrome therapy, tividenofusp alfa. 

The agreement gives Denali fresh financial firepower as it pushes toward potential FDA approval of the drug, its lead TransportVehicle-enabled enzyme replacement therapy for mucopolysaccharidosis type II (MPS II). The FDA is currently reviewing a Biologics License Application for accelerated approval, with a decision expected by 2026. 

“We are pleased to partner with Royalty Pharma, whose investment recognizes the value and potential of tividenofusp alfa for the Hunter community and supports our ability more broadly to realize the promise of the TransportVehicle platform,” said Ryan Watts, Chief Executive Officer of Denali Therapeutics. 

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

Royalty Pharma, the world’s largest buyer of biopharma royalties, framed the deal as a strategic bet on a therapy it believes could reshape care for patients with Hunter syndrome. 

“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,” said Pablo Legorreta, Chief Executive Officer and Chairman of the Board of Royalty Pharma. 

“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.” 

Under the deal’s terms, the agreement will close only if Denali wins FDA accelerated approval for tividenofusp alfa. Upon closing, Royalty Pharma will pay $200 million upfront. 

A second $75 million payment will be triggered if the therapy secures EMA approval by December 31, 2029. In return, Royalty Pharma will receive a 9.25% royalty on worldwide net sales. 

Royalty payments will end once Royalty Pharma achieves a 3.0x return, or 2.5x if that threshold is met by the first quarter of 2039, as per the deal. 

The deal further cements Denali’s position as a key player in the race to develop therapies that can cross the blood–brain barrier—a long-standing challenge in treating neurodegenerative and neurocognitive diseases.