Ascendis Pharma (ASND) seeks EMA approval for TransCon CNP in achondroplasia

Rhea-AI Filing Summary

Ascendis Pharma A/S reports that it has submitted a Marketing Authorisation Application to the European Medicines Agency for TransCon CNP (navepegritide) as a treatment for children with achondroplasia. Achondroplasia is described as a rare genetic condition that causes skeletal dysplasia and can significantly affect health, physical functioning, and quality of life.

TransCon CNP is an investigational, once-weekly prodrug of C-type natriuretic peptide designed to provide continuous exposure of active CNP throughout the body, including growth plates and skeletal muscle, with the goal of continuously inhibiting the overactive FGFR3 pathway that drives achondroplasia. The filing also notes that this 6-K is incorporated by reference into Ascendis Pharma’s existing Form S-8 and Form F-3 registration statements.

Positive

• Key regulatory milestone: Ascendis Pharma submitted a Marketing Authorisation Application to the European Medicines Agency for TransCon CNP to treat children with achondroplasia, advancing a potential rare disease therapy toward possible approval in Europe.

Negative

• None.

Insights

Biotech and regulatory strategy analyst

Ascendis advances TransCon CNP with an EMA marketing application for pediatric achondroplasia.

The submission of a Marketing Authorisation Application to the European Medicines Agency for TransCon CNP (navepegritide) marks a key regulatory milestone for Ascendis Pharma. The therapy targets children with achondroplasia, a rare skeletal dysplasia that can lead to substantial health and quality-of-life burdens, positioning this as a potential high-value rare disease indication if approved.

TransCon CNP is described as an investigational, once-weekly prodrug of C-type natriuretic peptide, designed to provide continuous exposure of active CNP and inhibit the overactive FGFR3 pathway associated with achondroplasia. The impact ultimately depends on EMA review outcomes and any subsequent approvals. Future company communications and filings following the October 8, 2025 submission may provide more detail on timelines and regulatory feedback.

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

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 October, 2025

Commission File Number: 001-36815

Ascendis Pharma A/S

(Exact Name of Registrant as Specified in Its Charter)

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 ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

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 and 333-285322) 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 8, 2025, the Company announced it has submitted a Marketing Authorisation Application to the European Medicines Agency for TransCon CNP (navepegritide) as a treatment for children with achondroplasia, a rare genetic condition that causes skeletal dysplasia and, for many affected individuals, significant health, physical functioning, and quality of life impacts. TransCon CNP is an investigational prodrug of C-type natriuretic peptide (“CNP”) administered once weekly, designed for continuous inhibition of the overactive FGFR3 pathway in achondroplasia by providing continuous exposure of active CNP to receptors on tissues throughout the body, including growth plates and skeletal muscle.

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 8, 2025				By:		/s/ Michael Wolff Jensen
						Michael Wolff Jensen
						Executive Vice President, Chief Legal Officer

FAQ

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

Ascendis Pharma announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency for TransCon CNP (navepegritide) as a treatment for children with achondroplasia.

What is TransCon CNP and how is it intended to work?

TransCon CNP is an investigational prodrug of C-type natriuretic peptide given once weekly. It is designed to provide continuous exposure of active CNP to receptors throughout the body, including growth plates and skeletal muscle, to continuously inhibit the overactive FGFR3 pathway in achondroplasia.

Which patient population is targeted by TransCon CNP in Ascendis Pharma's application?

The application targets children with achondroplasia, a rare genetic condition that causes skeletal dysplasia and can significantly impact health, physical functioning, and quality of life.

What regulatory body is reviewing Ascendis Pharma’s TransCon CNP application?

The European Medicines Agency (EMA) is the regulatory body to which Ascendis Pharma submitted the Marketing Authorisation Application for TransCon CNP.

How does this Form 6-K relate to Ascendis Pharma’s existing registration statements?

This Form 6-K is deemed incorporated by reference into Ascendis Pharma’s existing Form S-8 and Form F-3 registration statements, becoming part of those registration statements from the date it is filed.

What condition does achondroplasia cause according to Ascendis Pharma?

Achondroplasia is described as a rare genetic condition that causes skeletal dysplasia and, for many affected individuals, significant impacts on health, physical functioning, and overall quality of life.