Ascendis and BioMarin settle YUVIWEL dispute with royalty deal
Ascendis Pharma has signed a binding term sheet with BioMarin Pharmaceutical to resolve all litigation and intellectual property disputes related to YUVIWEL (navepegritide), its recently approved treatment for achondroplasia. The agreement grants Ascendis a non-exclusive, royalty-bearing worldwide licence to continue researching, developing, manufacturing and commercialising navepegritide-related products without restriction.
Under the financial terms, Ascendis will pay BioMarin royalties equivalent to 20% of net sales in the United States and 18% in the European Union, South Korea and Brazil, running from the first commercial sale of YUVIWEL in each respective country through to 20 May 2030. In exchange, BioMarin has agreed to waive certain regulatory rights and exclusivities, dismiss all proceedings, and provide a covenant not to sue covering the relevant intellectual property. Ascendis has similarly agreed to dismiss its own proceedings against BioMarin.
The deal in context
YUVIWEL received FDA approval in February 2026 to increase linear growth in paediatric patients aged two years and older with achondroplasia. Ascendis described uptake in the United States as "rapid" since launch, citing the drug's differentiated profile and what it characterised as a significant unmet need in achondroplasia and broader skeletal dysplasias. The company's Marketing Authorisation Application for YUVIWEL is currently under review by the European Medicines Agency, with a regulatory decision anticipated in the fourth quarter of 2026.
Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma, said the launch trajectory "reflects its differentiated profile and the large, unmet medical need it is addressing as an important new foundation of care in achondroplasia."
The settlement removes a significant legal overhang on the programme. The royalty rate of 20% in the US is a meaningful commercial concession but provides Ascendis with full operational freedom and avoids the risk of an injunction or further market disruption. Ascendis has separately stated it expects to generate more than €500 million in operating cash flow in 2026 and has set a target of €5 billion in revenue by 2030, though both figures are forward-looking projections and carry material uncertainty.
Market landscape and competitive positioning
Achondroplasia is a rare skeletal dysplasia caused by gain-of-function mutations in the FGFR3 gene. The commercial field has become increasingly competitive following the approval of BioMarin's own vosoritide (Voxzogo) in children with achondroplasia, which created the original basis for intellectual property tension between the two companies. Navepegritide operates via a different mechanism, delivering a prodrug of C-type natriuretic peptide administered once weekly, offering a distinct pharmacological profile compared with vosoritide's daily dosing regimen.
The resolution of this dispute may also carry read-across significance for other companies working on skeletal dysplasia or CNP-pathway programmes, as it establishes a commercial framework for the coexistence of BioMarin and Ascendis in overlapping indication space. For Ascendis, the clarity gained ahead of a likely EMA approval decision before the end of 2026 should support payer and market access discussions in Europe, where royalty terms at 18% are slightly more favourable than the US rate. Investors will be watching the pace of the EMA review and commercial uptake data in the US as the key near-term value drivers.