Current Report Filing (8-k)
15 February 2023 - 12:39AM
Edgar (US Regulatory)
0001322505
false
0001322505
2023-02-14
2023-02-14
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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):
February 14, 2023
ALBIREO PHARMA, INC.
(Exact name of registrant as specified in its
charter)
Delaware
(State or other jurisdiction of
incorporation) |
|
001-33451
(Commission File
Number) |
|
90-0136863
(IRS Employer
Identification No.) |
53 State Street, 19th Floor
Boston, Massachusetts
(Address of principal executive offices) |
|
02109
(Zip Code) |
(857) 254-5555
Registrant’s telephone number, including
area code
N/A
(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, par value $0.01 per share |
|
ALBO |
|
The Nasdaq
Capital 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
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.
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.
Date: February 14, 2023
|
By: |
/s/ Ronald H.W. Cooper |
|
Ronald H.W. Cooper |
|
President and Chief Executive Officer |
|
|
|
Albireo Pharma (NASDAQ:ALBO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Albireo Pharma (NASDAQ:ALBO)
Historical Stock Chart
From Apr 2023 to Apr 2024