Ascendis Pharma TransCon CNP gets positive EU opinion

The European Commission decision is expected during the fourth quarter of 2026; a German launch is expected in the first quarter of 2027 if authorization is granted.

Rhea-AI Filing Summary

Ascendis Pharma A/S (ASND) said the EMA’s CHMP adopted a positive opinion recommending EU marketing authorization for once-weekly TransCon CNP (navepegritide) to treat achondroplasia in children two years of age and older whose epiphyses are not closed. The application included data from three randomized, double-blind, placebo-controlled trials and up to three years of open-label extension data.

The European Commission’s final decision is expected during the fourth quarter of 2026. TransCon CNP was designated an orphan medicine during development, and the EMA will review whether that designation can be maintained. If authorized, Ascendis expects its first EU launch, under the YUVIWEL brand, in Germany during the first quarter of 2027.

Key Figures

Patient age: Two years of age and older Clinical trials: Three randomized, double-blind, placebo-controlled clinical trials Open-label extension data: Up to three years +2 more

5 metrics

Patient age Two years of age and older Proposed treatment population for achondroplasia

Clinical trials Three randomized, double-blind, placebo-controlled clinical trials Clinical data included in the application

Open-label extension data Up to three years Data included in the application

European Commission decision Expected during the fourth quarter of 2026 Final decision on the marketing authorization application

First EU launch Expected in Germany during the first quarter of 2027 If the European Commission grants authorization

Key Terms

Committee for Medicinal Products for Human Use, Marketing Authorisation Application, orphan medicine, open-label extension

4 terms

Committee for Medicinal Products for Human Use regulatory

"Committee for Medicinal Products for Human Use (CHMP)"

The Committee for Medicinal Products for Human Use is the expert scientific panel within the European medicines regulator that assesses whether medicines for people are safe, effective and of acceptable quality, and issues formal opinions used in the drug-approval process. Its assessments act like a gatekeeper or safety inspector for entering the European market, so the committee’s opinion can materially affect a drug’s commercial prospects, regulatory risk and a company’s stock valuation.

Marketing Authorisation Application regulatory

"review of the MAA for TransCon CNP"

A marketing authorisation application is the formal package a drug or medical-device maker submits to a health regulator to get permission to sell a product. Think of it as an application for a sales license: regulators review safety, effectiveness and manufacturing quality before granting permission. Investors watch these submissions because approval unlocks revenue and reduces development risk, while rejection or delays can materially affect a company’s value and timeline.

orphan medicine regulatory

"designated as an orphan medicine during its development"

A medicine designated as "orphan" is a drug or biological product intended to prevent, diagnose, or treat a disease or condition that is rare enough to meet a regulator's threshold for rarity; the designation is granted by health authorities and carries special development and commercial incentives (for example, reduced fees, protocol assistance, tax credits, or a period of market exclusivity) to encourage creating treatments for small patient populations. The designation is an administrative status that helps with development and regulatory processes but does not by itself mean the medicine is approved, safe, or effective for use.

open-label extension medical

"up to three years of open-label extension data"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

FAQ

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

What did CHMP recommend for ASND’s TransCon CNP?

CHMP adopted a positive opinion recommending EU marketing authorization for once-weekly TransCon CNP (navepegritide) to treat achondroplasia in children two years of age and older whose epiphyses are not closed.

What clinical evidence was included in Ascendis’ TransCon CNP application?

The application included clinical data from three randomized, double-blind, placebo-controlled clinical trials and up to three years of open-label extension data. TransCon CNP was designated an orphan medicine during development, and EMA will review whether that designation can be maintained.

When could ASND receive an EU decision and launch TransCon CNP?

The European Commission’s final decision is expected during the fourth quarter of 2026. If authorization is granted, Ascendis expects its first EU launch under the YUVIWEL brand in Germany during the first quarter of 2027.

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

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Available on EDGAR 10/16/2026 - 02:59 PM EDT Accepted by SEC EDGAR 10/16/2026 - 02:58 PM EDT 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 RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of October 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 October 16, 2026, the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for once-weekly TransCon CNP (navepegritide) in the European Union for the treatment of achondroplasia in children two years of age and older whose epiphyses are not closed. The final European Commission (EC) decision on Ascendis’ Marketing Authorisation Application (MAA) is expected during Q4 2026.

CHMP adopted its positive opinion following its review of the MAA for TransCon CNP, which included clinical data from three randomized, double-blind, placebo-controlled clinical trials and up to three years of open-label extension data. TransCon CNP was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.

If authorized by the EC, Ascendis expects its first EU launch of TransCon CNP under the brand name YUVIWEL^® to be in Germany during Q1 2027.

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 (i) the anticipated timing of the EC’s final decision on Ascendis’ MAA for TransCon CNP (navepegritide), expected during the fourth quarter of 2026, (ii) the potential for the EC to grant marketing authorization for TransCon CNP, and (iii) Ascendis’ expectation and anticipated timing for its first EU launch of TransCon CNP under the brand name YUVIWEL in Germany in the first quarter of 2027. 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: October 16, 2026				By:		/s/ Michael Wolff Jensen
						Michael Wolff Jensen
						Executive Vice President, Chief Legal Officer