<SEC-DOCUMENT>0001193125-19-061604.txt : 20190304
<SEC-HEADER>0001193125-19-061604.hdr.sgml : 20190304
<ACCEPTANCE-DATETIME>20190304063132
ACCESSION NUMBER:		0001193125-19-061604
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20190304
FILED AS OF DATE:		20190304
DATE AS OF CHANGE:		20190304

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:		19651820

	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>d662234d6k.htm
<DESCRIPTION>6-K
<TEXT>
<HTML><HEAD>
<TITLE>6-K</TITLE>
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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><FONT
STYLE="white-space:nowrap">FORM&nbsp;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
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">TO&nbsp;SECTION&nbsp;13a-16&nbsp;OR&nbsp;15d-16</FONT></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 March, 2018 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File <FONT STYLE="white-space:nowrap">Number:&nbsp;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 12 </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&nbsp;Hellerup</FONT> </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 <FONT STYLE="white-space:nowrap">Form&nbsp;20-F&nbsp;or</FONT> <FONT
STYLE="white-space:nowrap">Form&nbsp;40-F.</FONT> Form&nbsp;20-F&nbsp;&nbsp;&#9746; <FONT STYLE="white-space:nowrap">Form&nbsp;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 <FONT STYLE="white-space:nowrap">Form&nbsp;6-K&nbsp;in</FONT> paper as permitted by <FONT
STYLE="white-space:nowrap">Regulation&nbsp;S-T&nbsp;Rule</FONT> 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 <FONT
STYLE="white-space:nowrap">Form&nbsp;6-K&nbsp;in</FONT> paper as permitted by <FONT STYLE="white-space:nowrap">Regulation&nbsp;S-T&nbsp;Rule</FONT> 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 <FONT STYLE="white-space:nowrap">Form&nbsp;6-K&nbsp;shall</FONT> be deemed to be incorporated by reference into the registration statements on <FONT
STYLE="white-space:nowrap">Form&nbsp;S-8&nbsp;(Registration</FONT> <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">Numbers&nbsp;333-228576,&nbsp;333-203040,&nbsp;333-210810,&nbsp;333-211512,&nbsp;333-213412,&nbsp;333-214843&nbsp;and&nbsp;333-216883)&nbsp;
and</FONT></FONT></FONT></FONT></FONT></FONT></FONT> <FONT STYLE="white-space:nowrap">Form&nbsp;F-3&nbsp;(Registration</FONT> <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">Numbers&nbsp;333-209336,333-211511,&nbsp;333-216882,&nbsp;333-223134&nbsp;and&nbsp;333-225284)&nbsp;of</FONT></FONT></FONT></FONT></FONT> 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:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On March&nbsp;4, 2019, the Company announced positive <FONT STYLE="white-space:nowrap">top-line</FONT> results from the phase 3 heiGHt Trial, a randomized,
open-label, active-controlled trial that compared once-weekly TransCon Growth Hormone (&#147;hGH&#148;) to a daily growth hormone (Genotropin<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP>) in children with pediatric growth hormone
deficiency (&#147;GHD&#148;). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The trial met its primary objective, demonstrating that TransCon hGH was observed to be
<FONT STYLE="white-space:nowrap">non-inferior</FONT> and, additionally, superior to the daily hGH on the primary endpoint of annualized height velocity (&#147;AHV&#148;) at 52 weeks. In the primary analysis of the <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">intent-to-treat</FONT></FONT> population using ANCOVA, TransCon hGH demonstrated an AHV of 11.2 cm/year compared to 10.3 cm/year for the daily hGH. The treatment difference was 0.86 cm/year with a 95&nbsp;percent
confidence interval of 0.22 to 1.50 cm/year. The AHV for TransCon hGH was significantly greater than the daily hGH (p=0.0088). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The AHV was greater for
TransCon hGH than for the daily hGH at each visit, with the treatment difference reaching statistical significance from and including week 26 onward. The incidence of poor responders (AHV &lt; 8.0 cm/year) was 4&nbsp;percent and 11&nbsp;percent in
the TransCon hGH and daily hGH arms, respectively. All sensitivity analyses completed from the trial support the primary outcome, indicating the robustness of these results. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Results from the trial indicate that TransCon hGH was generally safe and well-tolerated, with adverse events consistent with the type and frequency observed
with daily hGH therapy and comparable between arms of the trial. Key safety observations: </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">No serious adverse events related to study drug were observed in either arm </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">One serious adverse event was observed in each arm (representing 1.0&nbsp;percent for TransCon hGH and
1.8&nbsp;percent for daily hGH), both determined to be unrelated to study drug </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">No treatment-emergent adverse events leading to discontinuation of study drug were observed in either arm
</P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Additional preliminary analyses from the heiGHt Trial: </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">No neutralizing antibodies detected, and low level (&lt;10 percent) of
<FONT STYLE="white-space:nowrap">low-titer</FONT> <FONT STYLE="white-space:nowrap">non-neutralizing</FONT> antibodies was similar between the two arms </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Height standard deviation score (&#147;SDS&#148;) at 52 weeks increased over baseline by 1.05 for TransCon hGH
and by 0.94 for the daily hGH, and the treatment difference in height SDS increased at each visit over 52 weeks </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Body Mass Index (&#147;BMI&#148;) SDS was stable over 52 weeks and was
<FONT STYLE="white-space:nowrap">-0.03</FONT> for TransCon hGH and -0.40 for the daily hGH at week 52 </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Mean hemoglobin A1c values were generally stable over the course of the trial and remained within the normal
range for both arms </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Observed peak and trough insulin-like growth<B> </B>factor<B>-</B>1<B>
(</B><FONT STYLE="white-space:nowrap">&#147;IGF-1&#148;)</FONT> SDS values were 1.3 and <FONT STYLE="white-space:nowrap">-0.5</FONT> over 52 weeks, respectively, for TransCon hGH compared to an approximate average
<FONT STYLE="white-space:nowrap">IGF-1</FONT> SDS of 0.0 for the daily hGH at week 52 </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">In a <FONT STYLE="white-space:nowrap">pre-defined</FONT> subset of 11 subjects,
<FONT STYLE="white-space:nowrap">IGF-1</FONT> levels were assessed during week 13 and results were similar to those reported in the TransCon hGH pediatric phase 2 trial </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Consecutive <FONT STYLE="white-space:nowrap">IGF-1</FONT> SDS values &gt;2.0 were uncommon (&lt;10&nbsp;percent
of subjects) and <FONT STYLE="white-space:nowrap">IGF-1</FONT> SDS &gt;3.0 were rare (&lt;3&nbsp;percent of subjects) </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Adverse events leading to dose reduction <FONT STYLE="white-space:nowrap">(IGF-1</FONT> levels or clinical
symptoms) occurred twice in the TransCon hGH arm (representing 1.9 percent) and once in the daily hGH arm (representing 1.8 percent) </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Two subjects in each treatment arm experienced mild injection site reactions that were considered adverse events
</P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The heiGHt Trial evaluated 161 <FONT STYLE="white-space:nowrap">treatment-na&iuml;ve</FONT> children with
GHD randomized in a 2:1 ratio to receive either once-weekly TransCon hGH (0.24 mg/kg/week subcutaneously, n=105) or daily Genotropin<SUP STYLE="font-size:85%; vertical-align:top"> </SUP>(34 &micro;g/kg/day or 0.24 mg/kg/week subcutaneously, n=56)
for 52 weeks. Of the 161 subjects, two subjects, one from each arm, withdrew from the trial prior to the final visit. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">TransCon hGH is designed to deliver
unmodified hGH, the same growth hormone used in daily therapies, at a predictable rate over one week. Currently in the U.S. and Europe, the only GHD treatment option for patients and their families is daily hGH injections. Patients receiving daily
therapy endure thousands of injections over the course of many years. This often leads to missed doses and patients who fail to meet expected outcomes. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The TransCon hGH phase 3 program includes the heiGHt, fliGHt and enliGHten Trials. <FONT STYLE="white-space:nowrap">Top-line</FONT> data for the fliGHt Trial,
evaluating TransCon hGH in subjects who switch from daily hGH, are expected in the second quarter of 2019. The enliGHten Trial is a long-term extension that provides subjects from the heiGHt and fliGHt Trials with the opportunity to continue
once-weekly TransCon hGH treatment. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company plans a clinical database lock for the TransCon hGH phase 3 program in the third quarter of 2019.
Subsequently, the company intends to submit a Biologics License Application (&#147;BLA&#148;) with the U.S. Food and Drug Administration for TransCon hGH to treat pediatric GHD in the first half of 2020. </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 (i)&nbsp;the timing of the Company&#146;s expected database lock and BLA submission for TransCon hGH and (ii)&nbsp;the
timing of the topline data from the fliGHt Trial. 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&#146;s TransCon hGH, TransCon PTH and TransCon CNP or other development programs;
unforeseen expenses related to the development of TransCon hGH, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and the Company&#146;s business generally;
delays in the development of TransCon hGH, TransCon PTH and TransCon CNP or other development programs 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&#146;s ability to obtain additional funding, if needed, to support the Company&#146;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&#146;s business in general, see the Company&#146;s current and
future reports filed with, or submitted to, the&nbsp;U.S. Securities and Exchange Commission&nbsp;(&#147;SEC&#148;), including the Company&#146;s Annual Report on Form <FONT STYLE="white-space:nowrap">20-F</FONT> for the year
ended&nbsp;December&nbsp;31, 2017, which the Company filed with the&nbsp;SEC&nbsp;on&nbsp;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 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:12pt; margin-bottom:0pt; 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="3"><B>Ascendis Pharma A/S</B></TD></TR>
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<TD VALIGN="top">Date: March&nbsp;4, 2019</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="bottom">Michael Wolff Jensen</TD></TR>
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<TD VALIGN="bottom">Senior Vice President, General Counsel</TD></TR>
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