December 4, 2025.
SOUTH SAN FRANCISCO, Calif. and NEW YORK — December 4, 2025 — Leads & Copy — Denali Therapeutics Inc. and Royalty Pharma plc have entered into a $275 million synthetic royalty funding agreement focused on future net sales of tividenofusp alfa, according to a recent press release.
Denali’s lead investigational TransportVehicle™-enabled enzyme replacement therapy, tividenofusp alfa, is being developed for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome).
The U.S. Food and Drug Administration (FDA) is reviewing a Biologics License Application (BLA) for accelerated approval of tividenofusp alfa, with a Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026.
According to Denali Therapeutics CEO Ryan Watts, Ph.D., the partnership with Royalty Pharma recognizes the potential of tividenofusp alfa and supports the company’s ability to realize the promise of the TransportVehicle platform.
Watts added that the additional funds will allow Denali to advance its development programs as it prepares for the launch of tividenofusp alfa.
Royalty Pharma will make an initial payment of $200 million at closing, according to Royalty Pharma CEO Pablo Legorreta. Royalty Pharma will be obligated to make an additional payment of $75 million upon achieving European Medicines Agency (EMA) approval of tividenofusp alfa by December 31, 2029.
In exchange, Royalty Pharma will receive a 9.25% royalty on worldwide net sales of tividenofusp alfa from Denali. The royalty payments will cease upon reaching a multiple of 3.0x, or 2.5x if achieved by the first quarter of 2039.
Gibson Dunn served as legal advisor to Denali, while Goodwin Procter and Maiwald acted as legal advisors to Royalty Pharma.
Royalty Pharma Investor Relations and Communications can be reached at +1 (212) 883-6637 or ir@royaltypharma.com.
Denali Investor Contact: Laura Hansen, Ph.D., hansen@dnli.com; Denali Media Contact: Erin Patton, epatton@dnli.com
Source: Denali Therapeutics
