UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TOSECTION 13a-16 OR15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of September, 2019
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 Form20-F or Form40-F.
Form20-F ☒ Form40-F ☐
Indicate by check mark if the registrant is submitting the Form6-K in paper as permitted by RegulationS-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form6-K in paper as permitted by RegulationS-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
This report on Form6-K shall be deemed to be incorporated by reference into the registration statements on FormS-8 (Registration Numbers333-228576,333-203040,333-210810,333-211512,333-213412,333-214843 and333-216883) and FormF-3 (Registration Numbers333-209336,333-211511,333-216882,333-223134 and333-225284) of Ascendis Pharma A/S (the “Company”) (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such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Following a subject visit in the Company’s ongoing enliGHten trial in September 2019, the Company completed the last visit for the long term clinical database for the TransCon hGH phase 3 program in pediatric growth hormone deficiency (“GHD”) for its regulatory filings with the U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”). The Company intends to submit a Biologics License Application to the FDA for TransCon hGH to treat pediatric GHD in the first half of 2020 and a Marketing Authorization Application to the EMA for TransCon hGH to treat pediatric GHD in the second half of 2020.
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 the Company’s 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 Company’s intention to submit and expected timing of submitting a Biologics License Application to the FDA and a Marketing Authorization Application to the EMA for TransCon hGH. The Company 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 the Company makes, including the following: unforeseen safety or efficacy results in the Company’s TransCon hGH; unforeseen expenses related to the development of TransCon hGH, general and administrative expenses, other research and development expenses and the Company’s business generally; delays in the development of TransCon hGH related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies and potential commercial sale, if approved; and the Company’s ability to obtain additional funding, if needed, to support the Company’s business activities. 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 the Company’s business in general, see the Company’s current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form20-F for the year ended December 31, 2018, which the Company filed with the SEC on April 3, 2019. Forward-looking statements do not reflect the potential impact of any futurein-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments the Company may enter into or make. The Company 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: September 26, 2019 | By: | /s/ Michael Wolff Jensen | ||||
Michael Wolff Jensen | ||||||
Chairman and Senior Vice President, Chief Legal Officer |