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<p style="margin-bottom:1pt;border-bottom:Solid 0.75pt #000000;padding-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
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<p style="text-align:center;margin-top:8pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">FORM 8-K </p>
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<p style="text-align:center;margin-top:8pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:13.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">CURRENT REPORT </p>
<p style="text-align:center;margin-top:8pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Pursuant to Section&#160;13 or 15(d) of the </p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Securities Exchange Act of 1934 </p>
<p style="text-align:center;margin-top:8pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Date of Report (Date of earliest event reported): August 27, 2018 </p>
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<p style="text-align:center;margin-top:8pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:24pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Ultragenyx Pharmaceutical Inc. </p>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(I.R.S. Employer<br />Identification No.)</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">60 Leveroni Court, Novato, California</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">94949</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Address of principal executive offices)</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Zip Code)</p></td>
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<p style="text-align:center;margin-top:8pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Registrant&#8217;s telephone number, including area code: (415)&#160;483-8800 </p>
<p style="text-align:center;margin-top:8pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Not Applicable</font> </p>
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<p style="margin-top:8pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: </p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Pre-commencement communications pursuant to Rule&#160;14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) </p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Pre-commencement communications pursuant to Rule&#160;13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:5.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:5.5pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR &#167;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR &#167;240.12b-2 of this chapter).</p>
<p style="margin-bottom:1pt;border-bottom:Solid 0.75pt #000000;padding-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Emerging growth company <font style="font-family:Segoe UI Symbol;">&#9744;</font></p>
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<p style="margin-bottom:1pt;border-bottom:Solid 0.75pt #000000;padding-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU2"></a><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition </font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">period for</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> </font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. </font><font style="font-family:Segoe UI Symbol;">&#9744;</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><a name="part_1_2_2"></a><a name="item_1_46_1"></a>Item 8.01<font style="margin-left:36pt;"></font><font style="color:#000000;">Other Events</font>.</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;text-indent:7.69%;"><font style="font-weight:normal;color:#000000;">On August 27, 2018, Ultragenyx Pharmaceutical Inc. (the &#8220;Company&#8221;) issued a press release (the &#8220;MPS Release&#8221;) announcing that the European Commission has approved the Marketing Authorization Application for Mepsevii&#8482; (vestronidase alfa), for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII.</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:7.69%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On August 29, 2018, the Company issued a press release (the &#8220;FAOD Release&#8221;) announcing that the U.S. Food and Drug Administration has accepted the Company&#8217;s most recent proposal to submit a New Drug Application for UX007 for the treatment of long-chain fatty acid oxidation disorders based on existing data.</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;text-indent:7.69%;">Copies of the MPS Release and the FAOD Release are filed herewith as Exhibits 99.1 and 99.2, respectively.</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Item 9.01<font style="margin-left:36pt;"></font><font style="color:#000000;">Financial Statements and Exhibits</font>.</p>
<p style="Background-color:#FFFFFF;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
<p style="Background-color:#FFFFFF;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">(d) <font style="font-weight:bold;">Exhibits</font></p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">99.1</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a href="rare-ex991_6.htm"><font style="text-decoration:underline;">Press Release, dated August 27, 2018</font></a></p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">99.2</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a href="rare-ex992_7.htm"><font style="text-decoration:underline;">Press Release, dated August 29, 2018</font></a></p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;;font-size:10pt;">&nbsp;</p>
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<p style="margin-top:12pt;margin-bottom:0pt;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;text-indent:7.69%;">&nbsp;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SIGNATURES </p>
<p style="margin-top:8pt;margin-bottom:0pt;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;text-indent:7.69%;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. </p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">/s/ Shalini Sharp</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Shalini Sharp</p></td>
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rare-8k_20180827.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 27, 2018
Ultragenyx Pharmaceutical Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-36276
27-2546083
(State or other jurisdiction of
incorporation)
(Commission File Number)
(I.R.S. Employer
Identification No.)
60 Leveroni Court, Novato, California
94949
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area code: (415) 483-8800
Not Applicable
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition
period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
☐
Item 8.01
Other Events
.
On August 27, 2018, Ultragenyx Pharmaceutical Inc. (the "Company") issued a press release (the "MPS Release") announcing that the European Commission has approved the Marketing Authorization Application for Mepsevii™ (vestronidase alfa), for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII.
On August 29, 2018, the Company issued a press release (the "FAOD Release") announcing that the U.S. Food and Drug Administration has accepted the Company's most recent proposal to submit a New Drug Application for UX007 for the treatment of long-chain fatty acid oxidation disorders based on existing data.
Copies of the MPS Release and the FAOD Release are filed herewith as Exhibits 99.1 and 99.2, respectively.
Item 9.01
Financial Statements and Exhibits
.
(d)
Exhibits
Exhibit No.
Description
99.1
Press Release, dated August 27, 2018
99.2
Press Release, dated August 29, 2018
* * *
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: August 29, 2018
Ultragenyx Pharmaceutical Inc.
By:
/s/ Shalini Sharp
Shalini Sharp
Executive Vice President, Chief Financial Officer