Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement

Core Insights - Denali Therapeutics and Royalty Pharma have entered into a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa, Denali's lead investigational therapy for mucopolysaccharidosis type II (MPS II) [1][4] - The FDA is currently reviewing a Biologics License Application (BLA) for accelerated approval of tividenofusp alfa, with a target date of April 5, 2026 [2] Company Overview - Denali Therapeutics is focused on developing biotherapeutics that can cross the blood-brain barrier using its proprietary TransportVehicle platform, aiming to address serious diseases including neurodegenerative and lysosomal storage disorders [6] - Royalty Pharma, established in 1996, is the largest buyer of biopharmaceutical royalties and funds innovation in the biopharmaceutical industry, collaborating with various entities from academic institutions to leading pharmaceutical companies [7] Transaction Details - The agreement stipulates an initial payment of $200 million from Royalty Pharma, with an additional $75 million contingent upon achieving EMA approval by December 31, 2029 [4] - Royalty Pharma will receive a 9.25% royalty on worldwide net sales of tividenofusp alfa, with payments ceasing upon reaching a multiple of 3.0x or 2.5x if achieved by Q1 2039 [4] Leadership Statements - Denali's CEO, Ryan Watts, expressed optimism about the partnership with Royalty Pharma, highlighting the potential of tividenofusp alfa for the Hunter community and the broader implications for the TransportVehicle platform [3] - Royalty Pharma's CEO, Pablo Legorreta, emphasized the innovative nature of tividenofusp alfa and its potential to address significant unmet needs in Hunter syndrome [3]