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 and 333-270088) and Form F-3 (Registration Numbers 333-209336, 333-211511, 333-216882, 333-223134, 333-225284 and
333-256571) 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this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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 December 11, 2023, the Company announced that
the U.S. Food & Drug Administration (FDA) has accepted for review the Companys resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with
hypoparathyroidism. The agency considered the resubmission a complete, class 2 response and set a Prescription Drug User Fee Act (PDUFA) goal date of May 14, 2024. In the United States, TransCon PTH (palopegteriparatide) is an
investigational prodrug of parathyroid hormone (PTH [1-34]) for adult patients with hypoparathyroidism.
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. Examples of such statements include, but are not limited to, statements relating to the PDUFA goal date of
May 14, 2024. 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 the following: dependence on third party manufacturers, distributors and service providers for Ascendis products and product candidates; unforeseen safety or efficacy results in
Ascendis development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis development
programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of
patient recruitment or other unforeseen delays; Ascendis ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors,
including inflation, the effects on its business from the worldwide COVID-19 pandemic and ongoing conflicts such as that in the region surrounding Ukraine and Russia. 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 16, 2023 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.