Denali inks $275 million royalty funding agreement

Shares of US drug developer Denali Therapeutics (Nasdaq: DNLI) closed up 5.8% at $20.11 yesterday, after it announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa with Royalty Pharma (Nasdaq: RPRX).

Tividenofusp alfa is Denali’s lead investigational TransportVehicle-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome). A Biologics License Application (BLA) for accelerated approval of tividenofusp alfa is under review by the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026.

“We are pleased to partner with Royalty Pharma, whose investment recognizes the value and potential of tividenofusp alfa for the Hunter community and supports our ability more broadly to realize the promise of the TransportVehicle platform,” said Ryan Watts, chief executive of Denali Therapeutics. “With these additional funds, we are well positioned to advance our development programs as we prepare for the launch of tividenofusp alfa, unlocking broad opportunities across serious diseases,” he noted.