Avadel Pharmaceuticals (AVDL) finishes enrollment in Phase 3 REVITALYZ trial

Rhea-AI Filing Summary

Avadel Pharmaceuticals plc reported that it has completed patient enrollment in REVITALYZ, its Phase 3 clinical trial evaluating LUMRYZ as a potential treatment for idiopathic hypersomnia. This marks a key development step for assessing whether LUMRYZ can help people with this chronic sleep disorder. The company stated that it expects to have data from the REVITALYZ study in the second quarter of 2026, which will help determine next steps for the program.

Insights

Biopharma clinical development analyst

Completion of Phase 3 enrollment is a key milestone, but results will drive outcomes.

Avadel Pharmaceuticals has finished enrolling patients in REVITALYZ, a Phase 3 study of LUMRYZ for idiopathic hypersomnia. In drug development, completing enrollment is important because it locks in the study population and allows the trial to progress toward final data without further recruitment risk.

The company indicates it expects data from REVITALYZ in the second quarter of 2026. That timing suggests the trial is moving according to its planned schedule, but the filing does not provide any information about efficacy or safety outcomes. Until data are available, the program’s success depends on how LUMRYZ performs against the trial’s endpoints.

The next notable event is the Phase 3 readout expected in the second quarter of 2026. Subsequent public communications will clarify whether the study met its objectives and what potential regulatory or commercial steps might follow.

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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.

Item 8.01 Other Events.

On December 18, 2025, the Company announced that the Company completed enrollment in REVITALYZ, a Phase 3 study evaluating LUMRYZ^TM 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.

Item 9.01 Exhibits.

(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

FAQ

What did Avadel Pharmaceuticals (AVDL) disclose in this 8-K?

Avadel Pharmaceuticals disclosed that it has completed patient enrollment in REVITALYZ, its Phase 3 trial evaluating LUMRYZ for idiopathic hypersomnia.

What is the REVITALYZ Phase 3 trial mentioned by Avadel Pharmaceuticals (AVDL)?

REVITALYZ is a Phase 3 clinical study designed to evaluate LUMRYZ as a potential treatment for idiopathic hypersomnia, a chronic sleep disorder.

Has Avadel Pharmaceuticals (AVDL) completed enrollment in the REVITALYZ trial?

Yes. The company stated that it has completed enrollment in the Phase 3 REVITALYZ trial for LUMRYZ in idiopathic hypersomnia.

When does Avadel Pharmaceuticals (AVDL) expect data from the REVITALYZ study?

Avadel Pharmaceuticals expects to have data from the REVITALYZ Phase 3 study in the second quarter of 2026.

Does this Avadel Pharmaceuticals (AVDL) filing include financial results?

No. The content focuses on clinical trial progress for LUMRYZ in idiopathic hypersomnia and does not present earnings or financial performance data.

Are the statements about the REVITALYZ trial considered forward-looking for Avadel Pharmaceuticals (AVDL)?

Yes. The company notes that expectations for data from REVITALYZ in the second quarter of 2026 are forward-looking statements subject to risks and uncertainties.