Ascendis与BioMarin就YUVIWEL专利争议达成全球和解及授权条款

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6-K
1
d139239d6k.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 August 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this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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 August 31, 2026, the Company announced that 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, the Company 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.
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 resolution of litigation and disputes between Ascendis and BioMarin pursuant to the binding term sheet and anticipated definitive agreement, and (ii) 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.
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: August 31, 2026
By:
/s/ Michael Wolff Jensen
Michael Wolff Jensen
Executive Vice President, Chief Legal Officer