BioMarin Pharmaceutical and Ascendis Pharma have reached a global settlement that resolves their patent disputes over Yuviwel, Ascendis’ once-weekly treatment for children with achondroplasia. Under the agreement, Ascendis will pay BioMarin royalties on Yuviwel sales in several major markets through 2030, while receiving a license covering BioMarin patents related to the treatment and its potential future uses.
- Ascendis will pay BioMarin 20% of Yuviwel net sales in the U.S. through May 2030.
- Royalties in the European Union, Brazil and South Korea will be 18% of net sales through the same period.
- The payments apply retroactively to Yuviwel’s first commercial sales in each applicable market.
- The settlement resolves patent disputes in the U.S., Brazil, Denmark, Germany and South Korea.
- BioMarin will dismiss its pending investigation before the U.S. International Trade Commission.
- Ascendis receives a worldwide, non-exclusive license covering Yuviwel and potential future indications.
Patent Dispute Comes to an End
The agreement brings an end to a series of legal disputes between the two pharmaceutical companies over intellectual property related to C-type natriuretic peptide (CNP) therapies.
BioMarin had argued that Ascendis’ Yuviwel infringed patents associated with CNP variants and its own achondroplasia treatment, Voxzogo (vosoritide). Litigation and related proceedings had been underway in several countries, including the United States, Germany, Denmark, Brazil and South Korea.
Under the settlement, BioMarin will dismiss the pending cases and provide Ascendis with a license covering relevant patents. The license applies to current and potential Yuviwel indications, including achondroplasia and hypochondroplasia, as well as combinations involving other medicines.
The binding term sheet also includes agreements preventing further challenges to the relevant BioMarin patents and limiting future infringement claims covered by the settlement.
Ascendis to Pay 20% U.S. Royalty
The most significant financial element of the agreement is the royalty structure.
Ascendis will pay BioMarin 20% of annual net Yuviwel sales in the United States, with the obligation applying retroactively from the drug’s first commercial sale through May 2030. In the European Union, Brazil and South Korea, the royalty will be 18% of annual net sales over the same period.
The arrangement means BioMarin will receive revenue from a competing treatment while allowing Ascendis to continue selling Yuviwel without the uncertainty created by the ongoing patent litigation.
Analysts cited by Fierce Pharma estimate that the royalty stream could generate approximately $280 million in U.S. revenue and $440 million from markets outside the U.S. through 2030, based on consensus sales projections.
Yuviwel Competes With BioMarin’s Voxzogo
Yuviwel and Voxzogo target the same underlying condition: achondroplasia, a genetic disorder that affects bone growth and results in disproportionate short stature.
BioMarin’s Voxzogo is administered daily, while Yuviwel is designed as a once-weekly injection. Yuviwel received FDA approval in February 2026 for increasing linear growth in children aged two and older with achondroplasia who have open growth plates.
Ascendis reported €8 million ($9.3 million) in Yuviwel revenue during the second quarter, following the drug’s U.S. launch in April. BioMarin said in July that about 90% of its U.S. patient population remained on Voxzogo at that point.
The settlement now gives BioMarin a direct financial interest in Yuviwel’s commercial performance as the newer therapy competes with Voxzogo.
Agreement Covers Future Indications
The settlement is not limited to achondroplasia.
The license covers Yuviwel-related products for hypochondroplasia, a rarer and generally milder skeletal disorder, as well as other current and potential indications. It also permits use of the covered products alongside other medicines.
The inclusion of hypochondroplasia could become relevant as both companies advance programs in that condition.
BioMarin reported positive Phase 3 results for Voxzogo in hypochondroplasia in May 2026 and plans to seek an additional approval. Ascendis is also planning a Phase 3 study of its CNP therapy for the condition. Any future Yuviwel approval in the covered markets would remain subject to the royalty terms through 2030.
Settlement Removes Restrictions on Development
For Ascendis, the agreement provides greater certainty around the future development of its CNP franchise.
The company will have a license covering research, development, manufacturing, use, sale and commercialization of products containing its CNP therapy. The agreement also removes the immediate threat posed by the ongoing patent proceedings in multiple jurisdictions.
Ascendis said the settlement allows it to continue developing navepegritide-related products without restrictions arising from the disputes.
The company’s TransCon CNP technology is designed to provide sustained exposure to active CNP following once-weekly administration. The treatment works on pathways involved in the excessive FGFR3 signaling associated with achondroplasia.
BioMarin Gains Compensation for Its Patent Portfolio
For BioMarin, the agreement provides a royalty stream from a product that competes directly with one of its established medicines.
BioMarin CEO Alexander Hardy said:
“This outcome incentivizes companies like BioMarin to keep investing in the kind of long-term innovation that is critical to bringing breakthrough treatments to the people who need them,”
The company has emphasized its longstanding investment in CNP biology and the development of Voxzogo, which became the first approved treatment specifically targeting the underlying growth mechanism associated with achondroplasia.
Global Litigation to Be Dismissed
The settlement resolves disputes across several jurisdictions.
In the United States, BioMarin will dismiss its Section 337 investigation before the International Trade Commission. The companies will also resolve litigation involving their intellectual property in Brazil, Denmark, Germany, South Korea and the Northern District of California.
The binding term sheet became effective on August 30. BioMarin and Ascendis intend to negotiate a more detailed final settlement and license agreement. If that agreement is not completed by September 24, the provisions of the binding term sheet will remain in force.
Yuviwel’s Commercial Expansion Continues
The settlement comes as Ascendis works to expand Yuviwel’s availability following its U.S. approval.
The company’s application for European approval is currently under review, with a regulatory decision expected in the fourth quarter of 2026. If approved, sales in the European Union would be subject to the 18% royalty under the settlement.
BioMarin has reached a global patent settlement with Ascendis Pharma covering Yuviwel (navepegritide), ending multiple legal disputes involving intellectual property rights and the treatment of achondroplasia. Under the agreement, Ascendis will pay BioMarin royalties based on Yuviwel sales in several major markets.
BioMarin and Ascendis Resolve Global Patent Disputes
BioMarin agreed to provide Ascendis with a non-exclusive, worldwide, royalty-bearing license covering certain patents associated with Yuviwel and related products. The agreement allows Ascendis to continue researching, developing, manufacturing, and commercializing navepegritide for current and potential indications.
