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): March 1, 2021 (March 1, 2021)
AVADEL PHARMACEUTICALS PLC
(Exact Name of Registrant as Specified
in its Charter)
| Ireland |
001-37977 |
98-1341933 |
| (State or other jurisdiction |
(Commission |
(IRS Employer |
| of incorporation) |
File Number) |
Identification No.) |
|
10 Earlsfort Terrace
Dublin 2, Ireland, D02 T380 |
Not Applicable |
| (Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number,
including area code: +353 1 485 1200
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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¨ |
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 |
|
American Depositary Shares*
Ordinary Shares, nominal value
$0.01 per share** |
AVDL
N/A |
The Nasdaq Global Market |
*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 March 1, 2021, Avadel Pharmaceuticals plc (the “Company”)
issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has accepted the Company’s
New Drug Application (“NDA”) for its product candidate, FT218, an investigational, once-nightly formulation of sodium
oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The FDA set a Prescription Drug
User Fee Act goal date of October 15, 2021 for the completion of its review of the NDA. 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
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: March 1, 2021 |
By: |
/s/ Jerad G. Seurer |
| |
Name: |
Jerad G. Seurer |
| |
Title: |
Vice President, Legal Affairs & Corporate Secretary |
