Denali Therapeutics announced a $275 million synthetic royalty funding agreement with Royalty Pharma plc that provides an upfront payment of $200 million and a contingent $75 million payable only if the European Medicines Agency grants marketing authorization for Tividenofusp alfa by December 31, 2029.
Under the terms, Royalty Pharma will receive a 9.25 % royalty on worldwide net sales of Tividenofusp alfa. Royalty payments will cease once the cumulative sales reach a multiple of 3.0× the total royalty paid, or 2.5× if the target is achieved by the first quarter of 2039, giving Denali a clear cap on future royalty obligations.
Tividenofusp alfa is Denali’s TransportVehicle‑enabled enzyme replacement therapy for Hunter syndrome (MPS II). The drug has received FDA Breakthrough Therapy designation and is under accelerated‑approval review, with a PDUFA target date of April 5, 2026. The EMA priority‑medicine designation and the contingent payment structure underscore the regulatory milestones that will unlock the full value of the deal.
The financing is non‑dilutive, allowing Denali to preserve shareholder equity while securing the working capital needed for late‑stage development, manufacturing scale‑up, and commercialization. As of September 30, 2025, Denali reported $872.9 million in cash, cash equivalents, and marketable securities, and a Q3 2025 net loss of $126.9 million versus $107.2 million in Q3 2024. The new funding will extend the company’s runway and reduce the risk of cash shortfalls during the critical launch window.
CEO Ryan Watts said the deal “positions Denali to advance our development programs as we prepare for the launch of Tividenofusp alfa, unlocking broad opportunities across serious diseases.” Royalty Pharma CEO Pablo Legorreta added that the partnership “provides a potential practice‑changing therapy that could transform the lives of patients with Hunter syndrome.”
The transaction validates Denali’s TransportVehicle platform, which enables therapeutics to cross the blood‑brain barrier, and signals confidence from a leading royalty‑financing firm. By securing upfront capital tied to regulatory milestones, Denali can accelerate its commercialization strategy without diluting existing shareholders, while Royalty Pharma gains a stake in a high‑potential product that addresses an unmet neurological need in a rare disease market.
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