Ascendis settles BioMarin patent fight with 20% US royalty on YUVIWEL

Ascendis Pharma agreed to pay BioMarin a 20 percent royalty on US sales of YUVIWEL, ending global patent disputes over the achondroplasia drug.

"The ongoing rapid uptake of YUVIWEL in the United States reflects its differentiated profile and the large, unmet medical need it is addressing as an important new foundation of care in achondroplasia and other types of skeletal dysplasia," Jan Mikkelsen, president and chief executive officer of Ascendis Pharma, said.

Under the binding term sheet announced Aug. 31, Ascendis will pay BioMarin 20 percent of net sales in the US and 18 percent in the European Union, South Korea and Brazil, retroactive from the first commercial sale in each country through May 20, 2030. BioMarin grants Ascendis a non-exclusive, worldwide, royalty-bearing license covering all current and potential indications, including hypochondroplasia, and waives certain regulatory rights and exclusivities. Both companies will dismiss all litigation in the Northern District of California, Germany, Denmark, South Korea and Brazil, including a US International Trade Commission investigation. The agreement also permits the use of YUVIWEL in combination therapies with other medicines.

The settlement removes legal uncertainty over YUVIWEL (navepegritide), a once-weekly injection approved by the FDA in February for children aged 2 and older with achondroplasia who have open growth plates. The drug is a prodrug of C-type natriuretic peptide designed to provide continuous exposure of active CNP to receptors throughout the body, counteracting overactive FGFR3 signaling in achondroplasia, the most common form of dwarfism. It is the first and only once-weekly treatment approved for the condition.

Ascendis reported €8 million in YUVIWEL revenue for the second quarter of 2026, with more than 220 unique patient enrollments by more than 100 prescribing healthcare providers and over 65 percent of enrollments approved for reimbursement in the US through July 31. The company expects to generate more than €500 million in operating cash flow in 2026 and targets €5 billion in revenue by 2030. The European Medicines Agency is reviewing the marketing authorization application, with a decision expected in the fourth quarter of 2026.

The royalty burden will weigh on Ascendis' margins as YUVIWEL scales, but the settlement removes a costly multi-jurisdiction legal overhang and secures unrestricted commercialization rights. For BioMarin, the agreement converts its patent position into a recurring revenue stream without further litigation costs. Investors will watch the EMA decision in Q4 2026 and whether US reimbursement expansion sustains the current enrollment pace.

This article is for informational purposes only and does not constitute investment advice.