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Ascendis and BioMarin sign binding term sheet on global YUVIWEL settlement and license

Ascendis Pharma and BioMarin entered a binding term sheet covering a global settlement and a royalty-bearing license tied to YUVIWEL and navepegritide-related products.

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Ascendis Pharma A/S (Nasdaq: ASND) said on Aug. 31, 2026 that it entered into a binding term sheet for a global settlement and license agreement with BioMarin Pharmaceutical Inc. related to the sale of YUVIWEL (navepegritide) and navepegritide-related products, according to GlobeNewswire PE.

Term sheet covers settlement and a worldwide license

The binding term sheet provides the terms and conditions under which the companies agreed to resolve “all litigation and disputes” between them, according to GlobeNewswire PE.

Under the terms described, BioMarin agreed to grant Ascendis a non-exclusive, worldwide, royalty-bearing license that allows Ascendis to continue researching, developing, manufacturing, and commercializing navepegritide-related products “without restriction.”

BioMarin also agreed to waive certain regulatory rights and exclusivities, dismiss all proceedings, and provide a covenant not to sue relating to the covered intellectual property.

Dismissals and royalty terms tied to net sales through May 2030

In exchange for BioMarin’s commitments, Ascendis agreed to dismiss all proceedings against BioMarin and to make royalty payments to BioMarin based on net sales of navepegritide-related products.

The royalty rates specified in the term sheet are 20% in the United States and 18% in the European Union, South Korea, and Brazil.

The royalty obligation runs “from the first commercial sale of YUVIWEL in the specific country through May 20, 2030,” according to GlobeNewswire PE.

Company commentary and financial expectations

Ascendis President and Chief Executive Officer Jan Mikkelsen said Ascendis believes “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.”

Mikkelsen also said Ascendis’s “patient focus” has been “a key driver” of its ability to deliver products it says “make a meaningful difference in patients’ lives.”

Ascendis said it expects to generate more than €500 million in operating cash flow in 2026 and believes it can achieve €5 billion in revenue in 2030.

YUVIWEL regulatory status and product details

Ascendis described TransCon CNP (navepegritide) as a prodrug of C-type natriuretic peptide (CNP) administered once weekly and designed to provide continuous exposure of active CNP to receptors on tissues throughout the body to counteract overactive FGFR3 signaling in achondroplasia.

In February 2026, TransCon CNP was approved by the U.S. Food & Drug Administration under the trade name YUVIWEL to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses.

Ascendis said its Marketing Authorisation Application for YUVIWEL is under review by the European Medicines Agency, with a regulatory decision anticipated in the fourth quarter of 2026.

(For widely known context, GlobeNewswire distributes company press releases, and the FDA and EMA are the primary drug regulators in the U.S. and European Union.)

Topics
  • #Ascendis Pharma
  • #BioMarin
  • #YUVIWEL
  • #navepegritide
  • #biopharma licensing
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