ALBIREO PHARMA, INC. : Other Events, Financial Statements and Exhibits (form 8-K)

Item 8.01 Other Events.

On February 14, 2023, Albireo Pharma, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application and issued a Prescription Drug User Fee Act (PDUFA) action date of June 15, 2023 for Bylvay (odevixibat) in patients with Alagille syndrome ("ALGS"). The press release also announced that Company has submitted a variation application to the European Medicines Agency seeking authorization of Bylvay in patients with ALGS and this submission has been accepted and validated. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits




Exhibit

Number                                     Description
  99.1       Press release dated February 14, 2023
104        Cover Page Interactive Data File (embedded within the Inline XBRL document).

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