Ascendis wins FDA orphan exclusivity for YUVIWEL

Ascendis Pharma A/S reports that the U.S. FDA has granted orphan drug exclusivity to YUVIWEL (navepegritide; developed as TransCon® CNP), and that YUVIWEL is now commercially available in the United States.

Rhea-AI Filing Summary

Ascendis Pharma A/S reports that the U.S. FDA has granted orphan drug exclusivity to YUVIWEL (navepegritide; developed as TransCon® CNP), and that YUVIWEL is now commercially available in the United States. YUVIWEL is the first and only once-weekly treatment approved to increase linear growth in children 2 years and older with achondroplasia and open epiphyses, providing continuous systemic exposure to CNP over the weekly dosing interval. The orphan drug exclusivity for YUVIWEL runs through February 27, 2033.

Positive

• YUVIWEL granted U.S. FDA orphan drug exclusivity through February 27, 2033, providing a multi-year period of market protection for treating children with achondroplasia in the specified indication.
• YUVIWEL is now commercially available in the United States as the first and only once-weekly treatment approved to increase linear growth in eligible children with achondroplasia, potentially expanding Ascendis’ revenue base.

Negative

• None.

Insights

Biotech regulatory and commercialization analyst

FDA orphan exclusivity and U.S. launch of YUVIWEL strengthen Ascendis’ growth-hormone franchise.

The report highlights that YUVIWEL, a once-weekly TransCon® CNP therapy, has received U.S. FDA orphan drug exclusivity and is now commercially available for children with achondroplasia aged 2 years and older with open epiphyses. Orphan exclusivity generally supports market protection around a specific indication.

The exclusivity period for YUVIWEL runs through February 27, 2033, which can help limit direct competition for this indication during that window. The product’s positioning as the first and only once-weekly treatment providing continuous systemic CNP exposure over the dosing interval may be a meaningful clinical and commercial differentiator, subject to real-world uptake, payer coverage, and competitive responses not detailed here.

Key Figures

Orphan drug exclusivity end date: February 27, 2033 Patient minimum age: 2 years Dosing frequency: Once-weekly

3 metrics

Orphan drug exclusivity end date February 27, 2033 Exclusivity period for YUVIWEL in the U.S.

Patient minimum age 2 years Children with achondroplasia eligible for YUVIWEL treatment

Dosing frequency Once-weekly YUVIWEL administration schedule for approved indication

Key Terms

orphan drug exclusivity, achondroplasia, TransCon® CNP, forward-looking statements, +1 more

5 terms

orphan drug exclusivity regulatory

"YUVIWEL (navepegritide; developed as TransCon® CNP) was granted orphan drug exclusivity"

A regulatory right that gives a drugmaker sole approval to market a medicine for a specific rare disease for a set number of years, during which the regulator will not approve the same medicine from competitors for that same use. For investors, this is like a temporary exclusive sales permit that can protect revenue and justify higher valuation because it reduces near‑term competition and helps the company recover development costs and capture market share.

achondroplasia medical

"to increase linear growth in children 2 years of age and older with achondroplasia"

A genetic condition that causes the most common form of short stature, where a specific change in a growth-control gene makes the long bones grow more slowly, producing a distinct body proportion and sometimes breathing, spinal or joint issues. It matters to investors because it defines a clear patient population, predictable medical needs and regulatory pathways for drugs or devices—similar to a niche market with steady, long-term demand for effective treatments or supportive care.

TransCon® CNP medical

"YUVIWEL (navepegritide; developed as TransCon® CNP)"

forward-looking statements regulatory

"This report contains forward-looking statements that involve substantial risks and uncertainties."

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

orphan drug exclusivity granted to YUVIWEL will run through February 27, 2033 regulatory

"The orphan drug exclusivity granted to YUVIWEL will run through February 27, 2033."

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Ascendis Pharma (ASND) announce about YUVIWEL in this 6-K?

Ascendis Pharma announced that YUVIWEL (navepegritide; TransCon® CNP) received U.S. FDA orphan drug exclusivity and is now commercially available in the United States for treating certain children with achondroplasia, marking an important regulatory and commercial milestone for the therapy.

How long does YUVIWEL’s U.S. FDA orphan drug exclusivity last for Ascendis Pharma (ASND)?

YUVIWEL’s orphan drug exclusivity from the U.S. FDA runs through February 27, 2033. During this period, the product benefits from regulatory market protection for its approved indication in children with achondroplasia as described, which can help limit direct competition in the U.S.

For which patients is YUVIWEL approved according to Ascendis Pharma’s 6-K?

YUVIWEL is approved to increase linear growth in children 2 years of age and older with achondroplasia who have open epiphyses. This targets a pediatric population with a defined skeletal growth condition, focusing on patients whose growth plates remain open for therapy response.

What makes YUVIWEL distinct among treatments for achondroplasia mentioned by Ascendis Pharma?

Ascendis states YUVIWEL is the first and only once-weekly treatment approved by the FDA to increase linear growth in eligible children with achondroplasia, and the only one providing continuous systemic exposure to C-type natriuretic peptide (CNP) over the weekly dosing interval.

Is YUVIWEL currently available in the United States according to Ascendis Pharma (ASND)?

Yes. The company reports that YUVIWEL is now commercially available in the United States. This means U.S. healthcare providers and eligible patients can access the once-weekly therapy for achondroplasia following its approval and orphan drug exclusivity grant.

What forward-looking risks does Ascendis Pharma highlight related to its products and YUVIWEL?

Ascendis notes risks including dependence on third-party manufacturers and distributors, regulatory review and approval challenges, clinical development uncertainties, potential safety or efficacy findings, market acceptance, pricing and reimbursement issues, competitive therapies, intellectual property matters, funding needs, and broader economic and geopolitical factors.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Form 6-K: How Foreign Companies Report to the SEC →

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Accepted by SEC EDGAR 04/07/2026 - 06:01 AM Learn about SEC filing dates

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO SECTION 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of April, 2026

Commission File Number: 001-36815

Ascendis Pharma A/S

(Translation of registrant’s name into English)

Tuborg Boulevard 12

DK-2900 Hellerup

Denmark

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒   Form 40-F ☐

INCORPORATION BY REFERENCE

This report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-203040, 333-210810, 333-211512, 333-213412, 333-214843, 333-216883, 333-228576, 333-254101, 333-261550, 333-270088, 333-277519, 333-281916, 333-285322 and 333-293854) and Form F-3 (Registration Numbers 333-209336 and 333-282196) of Ascendis Pharma A/S (the “Company” or “Ascendis”) (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

On April 6, 2026, the Company announced that YUVIWEL (navepegritide; developed as TransCon^® CNP) was granted orphan drug exclusivity by the U.S. Food & Drug Administration (“FDA”) and that YUVIWEL is now commercially available in the United States. YUVIWEL is the first and only once-weekly treatment approved by FDA to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and is the only one to provide continuous systemic exposure to CNP over the weekly dosing interval. The orphan drug exclusivity granted to YUVIWEL will run through February 27, 2033.

Forward-Looking Statements

This report contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this report regarding Ascendis’ future operations, 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 the anticipated timing of the orphan drug exclusivity granted to YUVIWEL. 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.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

				Ascendis Pharma A/S
Date: April 6, 2026				By:		/s/ Michael Wolff Jensen
						Michael Wolff Jensen
						Executive Vice President, Chief Legal Officer