Ascendis Pharma (Nasdaq: ASND) entered a binding term sheet with BioMarin for a global settlement and license covering YUVIWEL (navepegritide) and related products. BioMarin will grant Ascendis a non-exclusive, worldwide, royalty-bearing license and waive certain regulatory rights, dismiss proceedings, and provide a covenant not to sue on covered IP.
Ascendis will dismiss its proceedings and pay BioMarin royalties on net sales of navepegritide products of 20% in the United States and 18% in the EU, South Korea, and Brazil from first commercial sale in each country through May 20, 2030. Ascendis reiterated expectations of more than €500 million operating cash flow in 2026 and a potential €5 billion revenue in 2030.
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Positive
Global license and settlement securing non-exclusive, worldwide rights to navepegritide
Royalty structure defined at 20% in the U.S. and 18% in EU, South Korea, Brazil through May 20, 2030
Litigation fully resolved via mutual dismissal of all proceedings and covenant not to sue
2026 operating cash flow expected to exceed €500 million
2030 revenue aspiration of €5 billion reiterated
YUVIWEL FDA approval for pediatric achondroplasia obtained in February 2026
Negative
High royalty burden of 20%/18% on navepegritide net sales through May 20, 2030
Market Context
Insider records showed Net Buying, with 2,100 shares bought and 0 shares sold over 90 days. That pro...
Analysis
Insider records showed Net Buying, with 2,100 shares bought and 0 shares sold over 90 days. That provides ownership context for the settlement, while royalty payments and the pending European review remain watch points.
Key Figures
U.S. royalty rate:20%EU, South Korea and Brazil royalty rate:18%Operating cash flow expectation:More than €500 million+4 more
7 metrics
U.S. royalty rate20%Net sales of navepegritide-related products through May 20, 2030
EU, South Korea and Brazil royalty rate18%Net sales of navepegritide-related products through May 20, 2030
Operating cash flow expectationMore than €500 million2026 expectation
Revenue objective€5 billion2030 company objective
FDA approvalFebruary 2026YUVIWEL approval for pediatric patients with achondroplasia
Pediatric age threshold2 years of age and olderYUVIWEL indication with open epiphyses
European regulatory decisionFourth quarter of 2026Expected decision on YUVIWEL Marketing Authorisation Application
Week 104 radiographic data showed continued lower-extremity alignment improvements
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Pattern Detected
Positive clinical updates were followed by gains, while the recent earnings release and clinical-data presentation were followed by declines.
Key Terms
royalty-bearing license, covenant not to sue, prodrug, C-type natriuretic peptide, +2 more
6 terms
royalty-bearing licensefinancial
"grant Ascendis a non-exclusive, worldwide, royalty-bearing license"
A royalty-bearing license is a legal agreement that lets one party use another’s intellectual property—such as a patent, trademark, or copyrighted technology—in exchange for ongoing payments tied to sales, production, or a fixed fee per unit. For investors it signals a predictable cost and revenue sharing: licensors gain a steady income stream with lower operating risk, while licensees may face reduced margins but avoid large upfront development costs, like renting a recipe and paying per cake sold.
covenant not to sueregulatory
"dismiss all proceedings, and provide a covenant not to sue"
A covenant not to sue is a legal agreement in which one party promises not to bring a lawsuit against another party over specified claims or actions. It matters to investors because such covenants can limit future legal exposure, settle disputes without admitting liability, and affect a company’s risk profile and potential costs—similar to signing a truce that removes a particular legal threat but does not necessarily resolve all underlying issues.
prodrugmedical
"TransCon CNP (navepegritide) is a prodrug of C-type natriuretic peptide"
A prodrug is an inactive or less-active compound that is designed to be converted into an active drug inside the body, like a packaged meal that needs heating before it's ready to eat. For investors, prodrugs matter because this design can improve how a medicine is absorbed, reduce side effects, extend patent protection, or enable new dosing forms — all factors that can affect a drug's regulatory path, marketability, and commercial value.
C-type natriuretic peptidemedical
"is a prodrug of C-type natriuretic peptide (CNP)"
C-type natriuretic peptide is a small, naturally occurring protein the body uses to relax blood vessels and regulate cell growth, especially in blood vessel walls and bone. Think of it as a local traffic cop that calms traffic and tells cells when to slow down dividing. For investors, it matters because drugs or tests that mimic or measure this peptide can become treatments or diagnostics for heart, vascular and growth disorders, affecting market value and regulatory risk.
FGFR3 signalingmedical
"to counteract the overactive FGFR3 signaling in achondroplasia"
FGFR3 signaling is the process by which cells use the FGFR3 protein — like an antenna on the cell surface — to receive growth and repair messages from nearby molecules, controlling cell division, survival and bone development. Investors care because changes in this pathway can drive certain cancers and bone disorders, so therapies that block or adjust FGFR3 signaling can change clinical trial outcomes, regulatory approvals and the commercial value of drug developers.
open epiphysesmedical
"patients 2 years of age and older with achondroplasia with open epiphyses"
Open epiphyses are the regions at the ends of long bones where cartilage remains and the bone is still growing; they are commonly called growth plates. Like the flexible seam on a young tree that lets it get taller, open epiphyses indicate a still-developing skeleton, which matters to investors because treatments, dosing, safety assessments and trial eligibility can differ for people with open growth plates compared with fully matured bones.
COPENHAGEN, Denmark, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it has entered into a binding term sheet for a global settlement and license agreement with BioMarin Pharmaceutical Inc. (“BioMarin”) related to the sale of YUVIWEL® and navepegritide-related products. The binding term sheet provides the terms and conditions upon which the companies agree to resolve all litigation and disputes between the companies.
Under the terms, BioMarin has agreed to grant Ascendis a non-exclusive, worldwide, royalty-bearing license, allowing Ascendis to continue researching, developing, manufacturing, and commercializing navepegritide-related products without restriction.Furthermore, BioMarin has agreed to waive certain regulatory rights and exclusivities, dismiss all proceedings, and provide a covenant not to sue relating to the covered intellectual property.In exchange, Ascendis has agreed to dismiss all proceedings against BioMarin and to make royalty payments to BioMarin based on net sales of navepegritide-related products equal to 20% in the United States and 18% in the European Union, South Korea and Brazil from the first commercial sale of YUVIWEL in the specific country through May 20, 2030.
“The ongoing rapid uptake of YUVIWEL in the United States, we believe, 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,” said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. “Our patient focus has been a key driver of our ability to deliver products that make a meaningful difference in patients’ lives.”
As previously communicated, Ascendis expects to generate more than €500 million in operating cash flow in 2026 and believes that it can achieve €5 billion in revenue in 2030.
About TransCon CNP TransCon CNP (navepegritide) is a prodrug of C-type natriuretic peptide (CNP) administered once weekly, designed to provide continuous exposure of active CNP to receptors on tissues throughout the body to counteract the overactive FGFR3 signaling in achondroplasia. In February 2026, TransCon CNP was approved by the U.S. Food & Drug Administration (FDA) under the trade name YUVIWEL® to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. Ascendis Pharma’s Marketing Authorisation Application for YUVIWEL is under review by the European Medicines Agency, with a regulatory decision anticipated in the fourth quarter of 2026.
About Ascendis Pharma A/S Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.
Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, results, plans and objectives of management are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Examples of such statements include, but are not limited to, statements relating to (i) the resolution of litigation and disputes between Ascendis and BioMarin pursuant to the binding term sheet and anticipated definitive agreement, (ii) the anticipated impact of the settlement on Ascendis’ financial expectations, including expectations regarding operating cash flow in 2026 and Ascendis’ belief that it can achieve €5 billion in revenue in 2030, (iii) anticipated timing of a regulatory decision from the European Medicines Agency for YUVIWEL, and (iv) the continued research, development, manufacturing and commercialization of navepegritide-related products. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including, without limitation: dependence on third-party manufacturers, distributors, and service providers for Ascendis’ products and product candidates; risks related to regulatory review and approval, including the possibility of delays, requests for additional data or analyses, restrictions or limitations on use, approval with labeling that is more limited than expected, or failure to obtain approval in the United States, European Union, or other jurisdictions; clinical development risks, including that results from ongoing or future trials may not confirm earlier data; unforeseen safety or efficacy findings in development programs or on-market products; manufacturing, supply chain, quality, or logistics issues that could delay development or commercialization; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen research and development or selling, general and administrative expenses and other costs impacting Ascendis’ business generally; market acceptance, pricing, and reimbursement challenges, including payer coverage decisions and health technology assessments; competitive developments, including new or improved therapies; intellectual property protection, freedom-to-operate, and litigation risks; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; cybersecurity, data privacy, and information technology disruptions; and the impact of international economic, political, legal, compliance, public health, and business factors, including tariffs, trade policies, currency fluctuations, and geopolitical events. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 11, 2026, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.
What did Ascendis Pharma (ASND) announce about its settlement and license agreement with BioMarin on August 31, 2026?
Ascendis announced a binding term sheet for a global settlement and license with BioMarin covering YUVIWEL and navepegritide-related products. According to Ascendis, BioMarin will grant a non-exclusive, worldwide, royalty-bearing license, waive certain regulatory rights, dismiss all proceedings, and provide a covenant not to sue.
What are the royalty terms BioMarin will receive from Ascendis for YUVIWEL (ASND) and navepegritide-related products?
BioMarin will receive royalties on net sales of navepegritide-related products: 20% in the United States and 18% in the European Union, South Korea, and Brazil. According to Ascendis, these royalties apply from first commercial sale in each country through May 20, 2030.
How does the BioMarin settlement affect Ascendis Pharma’s ability to commercialize YUVIWEL (ASND) globally?
The settlement secures a non-exclusive, worldwide, royalty-bearing license from BioMarin, allowing Ascendis to continue researching, developing, manufacturing, and commercializing navepegritide-related products. According to Ascendis, BioMarin’s covenant not to sue and dismissal of proceedings reduce IP-related legal uncertainty around YUVIWEL commercialization.
What financial guidance did Ascendis Pharma (ASND) provide for 2026 operating cash flow and 2030 revenue?
Ascendis expects to generate more than €500 million in operating cash flow in 2026 and believes it can achieve €5 billion in revenue in 2030. According to Ascendis, these figures reflect its outlook following YUVIWEL’s launch and broader portfolio progression.
What is YUVIWEL (navepegritide) from Ascendis Pharma (ASND) and what is its approved indication in the United States?
YUVIWEL (navepegritide) is a once-weekly TransCon CNP prodrug designed to provide continuous CNP exposure. According to Ascendis, the FDA approved YUVIWEL in February 2026 to increase linear growth in pediatric patients aged 2 years and older with achondroplasia with open epiphyses.
When is the European Medicines Agency expected to decide on YUVIWEL (ASND) for achondroplasia?
Ascendis’ Marketing Authorisation Application for YUVIWEL is under review by the European Medicines Agency, with a regulatory decision anticipated in the fourth quarter of 2026. According to Ascendis, this decision will determine YUVIWEL’s potential availability for European patients with achondroplasia.
How does Ascendis Pharma (ASND) describe current U.S. uptake of YUVIWEL for achondroplasia?
Ascendis reports ongoing rapid uptake of YUVIWEL in the United States, reflecting what it believes is a differentiated profile and large unmet medical need. According to Ascendis, YUVIWEL is positioned as an important new foundation of care in achondroplasia and other skeletal dysplasias.
