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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