BioMarin settles global patent disputes with Ascendis over Yuviwel

  • BioMarin reached a binding settlement with Ascendis over global Yuviwel patent disputes.
  • Ascendis will pay 20% of U.S. net sales retroactively and 18% elsewhere through May 2030.
  • Yuviwel generated 8 million euros in second-quarter 2026 revenue for Ascendis.

BioMarin Pharmaceutical Inc. and Ascendis Pharma A/S reached a binding worldwide settlement on August 30, 2026, resolving global patent disputes over Yuviwel, including a U.S. International Trade Commission Section 337 investigation and related cases in multiple jurisdictions. Yuviwel, also known as navepegritide and developed as TransCon CNP, is an FDA-approved once-weekly injection for increasing linear height growth in children aged 2 and older with achondroplasia and open growth plates. Ascendis will pay BioMarin 20% of U.S. net sales retroactively from Yuviwel’s first commercial sale, plus 18% of sales in the European Union, Brazil and South Korea through May 2030. The agreement licenses BioMarin patents for all current and potential indications, including achondroplasia and hypochondroplasia, and permits combination use with other medicines. BioMarin will withdraw its ITC complaint and the parties will dismiss suits in Brazil, Denmark, Germany, South Korea and California’s Northern District, while Ascendis agreed not to challenge BioMarin’s patents and to a bilateral regulatory non-interference provision. Ascendis reported 8 million euros in Yuviwel revenue for the second quarter of 2026 and more than 220 patient enrollments through more than 100 prescribing healthcare providers by July 31, 2026. Its European Medicines Agency review remains underway, with a decision anticipated in the fourth quarter of 2026, while a Phase 3 hypochondroplasia trial is planned for the second half of the year. BioMarin shares fell 0.96% around the announcement; the company markets nine commercial products and has a market capitalization of about $12.52 billion.

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BioMarin settles global patent disputes with Ascendis over Yuviwel - CoinPost Terminal