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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): December 18, 2025
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 1 901 5201
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:
| ¨ |
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 |
|
Ordinary
Shares, nominal value $0.01 per share |
AVDL |
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. ¨
| Item 7.01 |
Regulation FD Disclosure. |
On December 18, 2025, Avadel Pharmaceuticals plc (the “Company”)
issued a press release titled “Avadel Pharmaceuticals Announces Completion of Enrollment in Phase 3 REVITALYZ™ Trial in Idiopathic
Hypersomnia.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information under this Item 7.01, including Exhibit 99.1 hereto,
is being furnished herewith and shall not be deemed “filed” for the 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 such information
be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly
set forth by specific reference in such filing.
On December 18, 2025, the Company announced
that the Company completed enrollment in REVITALYZ, a Phase 3 study evaluating LUMRYZTM as a potential treatment for idiopathic
hypersomnia. The Company expects data from REVITALYZ in the second quarter of 2026.
Cautionary Disclosure Regarding Forward-Looking Statements
This Current Report on Form 8-K includes “forward-looking statements”
within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions,
financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, statements regarding
the Company’s expectations for data from REVITALYZ in the second quarter of 2026. In some cases, forward-looking statements
can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,”
“look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,”
“next steps” and similar expressions and the negatives thereof (if applicable).
The Company’s forward-looking statements
are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider
reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance
that actual results and the results of the company’s business and operations will not differ materially from the results contemplated
in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements
include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual
Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (“SEC”)
on March 3, 2025, and subsequent SEC filings. Forward-looking statements speak only as of the date they are made and are not guarantees
of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake
any obligation to publicly update or revise our forward-looking statements, except as required by law.
(d) Exhibits
| 99.1 |
Press release issued by Avadel Pharmaceuticals plc on December 18, 2025, furnished herewith. |
| 104 |
Cover Page Interactive Data File (embedded with the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: December 18, 2025 |
AVADEL PHARMACEUTICALS PLC |
| |
|
|
| |
By: |
/s/ Jerad G. Seurer |
| |
|
Name: |
Jerad G. Seurer |
| |
|
Title: |
General Counsel & Corporate Secretary |
