Current Report Filing (8-k)
October 15 2021 - 5:06PM
Edgar (US Regulatory)
0001012477
false
0001012477
2021-10-15
2021-10-15
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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 Section 15(d)
of the Securities Exchange Act of 1934
Date
of report (Date of earliest event reported): October 15, 2021
AVADEL PHARMACEUTICALS PLC
(Exact Name of Registrant as Specified in its Charter)
Ireland
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001-37977
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98-1341933
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(State or other jurisdiction
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(Commission
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(IRS Employer
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of incorporation)
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File Number)
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Identification No.)
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10 Earlsfort Terrace
Dublin 2, Ireland, D02 T380
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Not Applicable
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number,
including area code: +353 1
920 1000
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 to the registrant under any of the following provisions:
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¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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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American Depositary Shares*
Ordinary Shares, nominal value
$0.01 per share**
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AVDL
N/A
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The Nasdaq Global Market
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*American Depositary
Shares may be evidenced by American Depositary Receipts. Each American Depositary Share represents one (1) Ordinary Share.
** Not for trading,
but only in connection with the listing of American Depositary Shares on The Nasdaq Global 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. ¨
On
October 15, 2021, Avadel Pharmaceuticals plc (the “Company”) issued a press release announcing that the U.S. Food and Drug
Administration (the “FDA”) notified the Company that its review of the new drug application (“NDA”) for the Company’s
lead product candidate, FT218, was still ongoing. In February 2021, the FDA accepted Avadel's NDA for FT218 and assigned a target action date of October 15, 2021. A copy of the press release is furnished as Exhibit 99.1 to this
Current Report on Form 8-K and incorporated herein by reference.
(d) Exhibits
104
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Cover Page Interactive Data File (embedded with the Inline XBRL
document).
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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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AVADEL PHARMACEUTICALS PLC
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Date: October 15, 2021
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By:
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/s/ Jerad G. Seurer
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Name:
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Jerad G. Seurer
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Title:
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Vice President, Legal Affairs & Corporate Secretary
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