Royalty Pharma and Denali have entered into a $275 million financing agreement which, pursuant to a synthetic royalty agreement, is 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 (MPS II, Hunter syndrome). A Biologics License Application (BLA) for accelerated approval is currently under review by the U.S. Food and Drug Administration (FDA); the Prescription Drug User Fee Act (PDUFA) target date is April 5, 2026.
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