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.





(d) Exhibits




Exhibit

Number                                   Description
  99.1       Press release of Albireo Pharma, Inc., dated July 19, 2021, announcing
           EMA approval of Bylvay.
  99.2       Press release of Albireo Pharma, Inc., dated July 20, 2021, announcing
           FDA approval of Bylvay and including certain second quarter financial
           results.
104        Cover Page Interactive Data File (embedded within the Inline XBRL
           document).

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