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  <title>8-K</title>
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  <div class="main-content-container" style="z-index:5;position:relative;"><p style="border-top:2.25pt double #000000;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">&#160;</span></p><p style="font-size:10pt;margin-top:5.75pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:18pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">UNITED STATES<br/>SECURITIES AND EXCHANGE COMMISSION<br/></span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">WASHINGTON, D.C. 20549</span></p><p style="margin-left:40%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;border-bottom:0.75pt solid #000000;margin-right:40%;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">&#160;</span></p><h2 style="font-size:10pt;margin-top:10pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:18pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">FORM </span><span style="font-size:18pt;font-family:'Calibri',sans-serif;"><ix:nonNumeric id="F_168385f5-6a0d-461e-8990-f5aa8a935889" contextRef="C_0c9299dc-1fc6-425c-874e-2ab58e5702e2" name="dei:DocumentType"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:18pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">8-K</span></ix:nonNumeric></span></h2><p style="margin-left:40%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;border-bottom:0.75pt solid #000000;margin-right:40%;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">&#160;</span></p><p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">CURRENT REPORT</span></p><p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:6pt;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</span></p>
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  <div class="main-content-container" style="z-index:5;position:relative;"><h2 style="font-size:10pt;margin-top:18pt;font-family:Times New Roman;margin-bottom:6pt;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-kerning:none;min-width:fit-content;"></span>&#160;</h2>
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     <td style="padding-top:0in;padding-left:0in;vertical-align:top;padding-bottom:0in;padding-right:0in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">Item 8.01</span></p></td>
     <td style="padding-top:0in;padding-left:0in;vertical-align:top;padding-bottom:0in;padding-right:0in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">Other Events.</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;"> </span></p></td>
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   </table><p style="text-indent:6.667%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;"> </span></p><p style="text-indent:6.667%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">On July 11, 2025, Ultragenyx Pharmaceutical Inc. (the &#8220;Company&#8221;) announced that the U.S. Food and Drug Administration (the &#8220;FDA&#8221;) has issued a Complete Response Letter (&#8220;CRL&#8221;) for its Biologics License Application (&#8220;BLA&#8221;) for UX111 (ABO-102) AAV gene therapy as a treatment for patients with Sanfilippo syndrome type A (MPS IIIA).</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;"> </span></p><p style="text-indent:6.667%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;"> </span></p><p style="text-indent:6.667%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">In the CRL, the FDA requested that the Company provide additional information and improvements related to specific aspects of chemistry, manufacturing and controls (&#8220;CMC&#8221;) and observations from the recently completed manufacturing facility inspections. The Company believes that these observations are readily addressable, related to facilities and processes, and are not directly related to the quality of the product. The Company will be working with the FDA over the next few months to resolve the observations. Once resolution is achieved, the Company expects to resubmit the BLA and anticipates up to a six-month review period to follow the resubmission.</span></p><p style="text-indent:6.667%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;"> </span></p><p style="text-indent:6.667%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">Clinical review had been ongoing and the FDA has acknowledged that the neurodevelopmental outcome data provided to date are robust and the biomarker data provide additional supportive evidence. The CRL did not note any review issues related to the clinical data package nor clinical inspections, and asked that updated clinical data from current patients be included in the resubmission.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;"> </span></p><p style="text-indent:6.667%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;"> </span></p><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;"> </span></p><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:'Calibri',sans-serif;font-style:italic;font-kerning:none;min-width:fit-content;">Cautionary Note Regarding Forward-Looking Statements</span></p><p style="text-indent:6.667%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, &#8220;anticipates,&#8221; &#8220;continue,&#8221; &#8220;will,&#8221; or other similar terms or expressions that concern the Company&#8217;s expectations, plans and intentions. Forward-looking statements include, without limitation, statements related to the Company&#8217;s ability to provide the requested documentation and address the comments in the CRL to the satisfaction of the FDA, the development, timing and progress of UX111, including the timing of resubmission of the BLA and the timing of FDA review of any such resubmission, the timing and outcome of any FDA inspections related to UX111, the timing of future regulatory interactions related to UX111, including the potential Type A meeting, the outcome of any BLA resubmission, business plans and objectives for UX111, expectations regarding the tolerability and safety of UX111, and future clinical and regulatory developments for UX111. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals, the ability of the company to successfully develop UX111, the Company&#8217;s ability to achieve its projected development goals in its expected timeframes, risks related to adverse side effects, risks related to reliance on third party partners to conduct certain activities on the company&#8217;s behalf, smaller than anticipated market opportunities for the Company&#8217;s products and product candidates, manufacturing risks, the Company&#8217;s limited experience in operating its own manufacturing facility, the ability of the Company and its third party manufacturers to comply with regulatory requirements, competition from other therapies or products, and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the company&#8217;s future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of Ultragenyx&#8217;s products and drug candidates. The Company undertakes no obligation to update or revise any forward-looking statements. 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 business of the Company in general, see the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 7, 2025, and its subsequent periodic reports filed with the SEC.</span></p><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">&#160;</span></p><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-kerning:none;min-width:fit-content;">&#160;</span></p></div>
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  <div class="main-content-container" style="z-index:5;position:relative;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:9.35pt;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">SIGNATURES</span></p><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:9.35pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:'Calibri',sans-serif;font-kerning:none;min-width:fit-content;">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.</span></p>
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8-K
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):
July 11, 2025
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)
(IRS 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
(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))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value
RARE
Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 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 July 11, 2025, Ultragenyx Pharmaceutical Inc. (the "Company") announced that the U.S. Food and Drug Administration (the "FDA") has issued a Complete Response Letter ("CRL") for its Biologics License Application ("BLA") for UX111 (ABO-102) AAV gene therapy as a treatment for patients with Sanfilippo syndrome type A (MPS IIIA).
In the CRL, the FDA requested that the Company provide additional information and improvements related to specific aspects of chemistry, manufacturing and controls ("CMC") and observations from the recently completed manufacturing facility inspections. The Company believes that these observations are readily addressable, related to facilities and processes, and are not directly related to the quality of the product. The Company will be working with the FDA over the next few months to resolve the observations. Once resolution is achieved, the Company expects to resubmit the BLA and anticipates up to a six-month review period to follow the resubmission.
Clinical review had been ongoing and the FDA has acknowledged that the neurodevelopmental outcome data provided to date are robust and the biomarker data provide additional supportive evidence. The CRL did not note any review issues related to the clinical data package nor clinical inspections, and asked that updated clinical data from current patients be included in the resubmission.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, "anticipates," "continue," "will," or other similar terms or expressions that concern the Company's expectations, plans and intentions. Forward-looking statements include, without limitation, statements related to the Company's ability to provide the requested documentation and address the comments in the CRL to the satisfaction of the FDA, the development, timing and progress of UX111, including the timing of resubmission of the BLA and the timing of FDA review of any such resubmission, the timing and outcome of any FDA inspections related to UX111, the timing of future regulatory interactions related to UX111, including the potential Type A meeting, the outcome of any BLA resubmission, business plans and objectives for UX111, expectations regarding the tolerability and safety of UX111, and future clinical and regulatory developments for UX111. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals, the ability of the company to successfully develop UX111, the Company's ability to achieve its projected development goals in its expected timeframes, risks related to adverse side effects, risks related to reliance on third party partners to conduct certain activities on the company's behalf, smaller than anticipated market opportunities for the Company's products and product candidates, manufacturing risks, the Company's limited experience in operating its own manufacturing facility, the ability of the Company and its third party manufacturers to comply with regulatory requirements, competition from other therapies or products, and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the company's future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of Ultragenyx's products and drug candidates. The Company undertakes no obligation to update or revise any forward-looking statements. 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 business of the Company in general, see the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 7, 2025, and its subsequent periodic reports filed with the SEC.
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.
Ultragenyx Pharmaceutical Inc.
Date:
July 11, 2025
By:
/s/ Howard Horn
Howard Horn
Executive Vice President, Chief Financial Officer, Corporate Strategy