Royalty Pharma, Denali Therapeutics enter $275M royalty funding agreement

Royalty Pharma (RPRX) and Denali Therapeutics (DNLI) announced a $275M synthetic royalty funding agreement based on future net sales of tividenofusp alfa. Tividenofusp alfa is Denali’s lead investigational TransportVehicle-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II. A Biologics License Application for accelerated approval of tividenofusp alfa is under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act target date of April 5, 2026. The transaction is subject to various closing conditions, including Denali achieving U.S. FDA accelerated approval of tividenofusp alfa. At the closing, Royalty Pharma will make an initial payment of $200M and Royalty Pharma will be obligated to make an additional payment of $75M upon achieving European Medicines Agency 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 to Royalty Pharma will cease upon reaching a multiple of 3.0x, or 2.5x if achieved by the first quarter of 2039.