Denali Therapeutics (DNLI) and Royalty Pharma (RPRX) announced a $275 million 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, PDUFA, target date of April 5, 2026.
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