Current Report Filing (8-k)
21 Juli 2021 - 12:01PM
Edgar (US Regulatory)
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2021-07-19
2021-07-19
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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 19, 2021
ALBIREO PHARMA, INC.
(Exact name of registrant as specified in
its charter)
Delaware
(State or other jurisdiction of
incorporation)
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001-33451
(Commission File
Number)
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90-0136863
(IRS Employer
Identification No.)
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10 Post Office Square, Suite 1000
Boston, Massachusetts
(Address of principal executive offices)
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02109
(Zip Code)
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(857) 254-5555
Registrant’s telephone number, including
area code
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))
Securities registered pursuant to Section 12(b) of
the Act:
Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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Common Stock
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ALBO
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The Nasdaq Capital Market
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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 2.02 Results of Operations and Financial
Condition and Item 8.01 Other Events.
On
July 19, 2021, Albireo Pharma, Inc. (“Albireo”) issued a press release announcing receipt of approval from
the European Medicines Agency (EMA) for Bylvay (odevixibat), the first drug approved for the treatment of patients with all subtypes of
progressive familial intrahepatic cholestasis (PFIC). The full text of the press release is filed as Exhibit 99.1 to this Current
Report on Form 8-K.
On July 20,
2021, Albireo issued a press release announcing U.S. Food & Drug Administration (FDA) approval of Bylvay for the treatment
of pruritis in patients with all subtypes of PFIC. The press release regarding FDA approval included certain financial results for
the second quarter ended June 30, 2021. These financial results are preliminary and are subject to completion of financial
closing procedures. As a result, these financial results may differ from the results that will be reflected in our financial
statements as of and for the quarter ended June 30, 2021. The full text of the press release is filed (except as noted below) as
Exhibit 99.2 to this Current Report on Form 8-K.
The financial results
furnished as part of Exhibit 99.2 shall not be deemed to be “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall
it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly
set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
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.
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ALBIREO PHARMA, INC.
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Date: July 20, 2021
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/s/ Ronald H.W. Cooper
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Ronald H.W. Cooper
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President and Chief Executive Officer
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