Ascendis Pharma 的 YUVIWEL 获 EMA CHMP 正面意见，但美股盘中未见正向重定价

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6-K
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d167361d6k.htm
6-K
6-K
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this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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