<SEC-DOCUMENT>0001193125-18-247266.txt : 20180813
<SEC-HEADER>0001193125-18-247266.hdr.sgml : 20180813
<ACCEPTANCE-DATETIME>20180813160207
ACCESSION NUMBER:		0001193125-18-247266
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20180813
FILED AS OF DATE:		20180813
DATE AS OF CHANGE:		20180813

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Ascendis Pharma A/S
		CENTRAL INDEX KEY:			0001612042
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			G7
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36815
		FILM NUMBER:		181012240

	BUSINESS ADDRESS:	
		STREET 1:		TUBORG BOULEVARD 12
		CITY:			HELLERUP
		STATE:			G7
		ZIP:			DK-2900
		BUSINESS PHONE:		45 70 22 22 44

	MAIL ADDRESS:	
		STREET 1:		TUBORG BOULEVARD 12
		CITY:			HELLERUP
		STATE:			G7
		ZIP:			DK-2900
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d607105d6k.htm
<DESCRIPTION>6-K
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">6-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF
FOREIGN PRIVATE ISSUER </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO <FONT STYLE="white-space:nowrap">SECTION&nbsp;13a-16</FONT> OR
<FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of August, 2018 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number: <FONT STYLE="white-space:nowrap">001-36815</FONT> </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>Ascendis Pharma A/S </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact Name of Registrant as Specified in Its Charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Tuborg
Boulevard 5 </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B><FONT STYLE="white-space:nowrap">DK-2900</FONT> Hellerup </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Denmark </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of
principal executive offices) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether the registrant files or will file annual reports under cover of Form <FONT STYLE="white-space:nowrap">20-F</FONT> or Form <FONT
STYLE="white-space:nowrap">40-F.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form
<FONT STYLE="white-space:nowrap">20-F&nbsp;&nbsp;&#9746;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form</FONT> <FONT STYLE="white-space:nowrap">40-F&nbsp;&nbsp;&#9744;</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if the registrant is submitting the Form <FONT STYLE="white-space:nowrap">6-K</FONT> in paper as permitted by Regulation <FONT
STYLE="white-space:nowrap">S-T</FONT> Rule 101(b)(1):&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if the registrant is submitting the Form <FONT
STYLE="white-space:nowrap">6-K</FONT> in paper as permitted by Regulation <FONT STYLE="white-space:nowrap">S-T</FONT> Rule 101(b)(7):&nbsp;&nbsp;&#9744; </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>INCORPORATION BY REFERENCE </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This report on Form <FONT STYLE="white-space:nowrap">6-K</FONT> shall be deemed to be incorporated by reference into the registration statements on Form <FONT
STYLE="white-space:nowrap">S-8</FONT> (Registration Numbers <FONT STYLE="white-space:nowrap">333-203040,</FONT> <FONT STYLE="white-space:nowrap">333-210810,</FONT> <FONT STYLE="white-space:nowrap">333-211512,</FONT>
<FONT STYLE="white-space:nowrap">333-213412,</FONT> <FONT STYLE="white-space:nowrap">333-214843</FONT> and <FONT STYLE="white-space:nowrap">333-216883)</FONT> and Form <FONT STYLE="white-space:nowrap">F-3</FONT> (Registration Numbers <FONT
STYLE="white-space:nowrap">333-209336,</FONT> <FONT STYLE="white-space:nowrap">333-211511,</FONT> <FONT STYLE="white-space:nowrap">333-216882,</FONT> <FONT STYLE="white-space:nowrap">333-223134</FONT> and
<FONT STYLE="white-space:nowrap">333-225284)</FONT> of Ascendis Pharma A/S (the &#147;Company&#148;) (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. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Based on the Company&#146;s ongoing strategic
review of the global regulatory and commercial landscape for TransCon Parathyroid Hormone (&#147;PTH&#148;), and the Company&#146;s initial post-Phase 1 interactions with the Food and Drug Administration (the &#147;FDA&#148;), the Company intends to
update the plans for its TransCon PTH development program. The Company expects the elements of the program relating to Chemistry, Manufacturing and Controls (CMC), the associated device and nonclinical objectives to remain materially unchanged, and
the Company intends to expand its Phase 3 program to include a global pivotal trial incorporating trial sites in Japan and possibly other Asian countries. The Company also intends to conduct a Phase 2 trial in subjects with hypoparathyroidism. The
Company believes the Phase 2 trial will provide experience with dosing regimens of TransCon PTH, and with titration of calcium and active vitamin D supplementation, which may optimize the Phase 3 trial. Based upon recent preliminary feedback from
the FDA, the Company initially expects that the Phase 2 trial may be a randomized placebo-controlled study following subjects for approximately four weeks. The Phase 2 trial will have the potential to enable clinical validation of other outcome
measures, including the ability to discontinue active vitamin D and calcium supplementation, and to reduce urine calcium excretion. The Company plans to initiate the Phase&nbsp;2 study in the first quarter of 2019, with topline data expected by
early 2020. Subjects from this Phase 2 study are expected to be eligible to enter into a long-term extension study. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I>Forward Looking Statements
</I></B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>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&#146;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&#146;s expectations regarding (i)&nbsp;its plans for updating the TransCon PTH development program, (ii)&nbsp;its plans to incorporate trial sites in Japan and possibly other Asian countries, (iii)&nbsp;its intention to conduct a Phase 2
trial in subjects with hypoparathyroidism, (iv)&nbsp;the possibility that the Phase 2 trial will provide experience with dosing regimens of TransCon PTH, and with titration of calcium and active vitamin D supplementation, (v)&nbsp;its expectation
that the Phase 2 trial may be a randomized placebo-controlled study following subjects for approximately four weeks, (vi)&nbsp;the possibility that the Phase 2 trial will have the potential to enable clinical validation of other outcome measures,
(vii)&nbsp;the expected timing for initiation of (and topline data from) the Phase 2 study, and (viii)&nbsp;the expectation that subjects from the Phase 2 study will be eligible to enter into a long-term extension study. 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 TransCon PTH trials; unforeseen expenses related to the development of TransCon PTH; delays in the development of TransCon PTH related to manufacturing, regulatory
requirements, speed of patient recruitment or other unforeseen issues; dependence on third party manufacturers to supply trial drug for planned clinical studies; and the Company&#146;s ability to obtain additional funding, if needed, to support its
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&#146;s business in general,
see the Company&#146;s current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (&#147;SEC&#148;), including its Annual Report on <FONT STYLE="white-space:nowrap">Form&nbsp;20-F</FONT> filed with the SEC on
March&nbsp;28, 2018. Forward-looking statements do not reflect the potential impact of any future <FONT STYLE="white-space:nowrap">in-licensing,</FONT> collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that 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. </I></P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">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. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" COLSPAN="5"><B>Ascendis Pharma A/S</B></TD></TR>
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<TD VALIGN="top">Date: August&nbsp;13, 2018</TD>
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<TD VALIGN="top">By:</TD>
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<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Michael Wolff Jensen</TD></TR>
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<TD VALIGN="top" COLSPAN="3">Michael Wolff Jensen</TD></TR>
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<TD VALIGN="top" COLSPAN="3">Chairman and Senior Vice President, General Counsel</TD></TR>
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