Avadel Pharmaceuticals plc filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction | (Commission | (IRS Employer |
| of incorporation) | File Number) | Identification No.) |
Not Applicable | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including
area code: +
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 |
|
|
|
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 May 6, 2025, Avadel Pharmaceuticals plc (the “Company”) issued a press release titled “Avadel Pharmaceuticals Announces Favorable Ruling in Appeal of Delaware Court Injunction.” 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 May 6, 2025, the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled in favor of the Company in a suit brought by Jazz Pharmaceuticals, Inc., overturning parts of the injunction imposed by the U.S. District Court for the District of Delaware (the “Delaware Court”) regarding LUMRYZTM as a potential treatment of indications beyond narcolepsy. The Federal Circuit vacated the portion of the injunction that prohibited the Company from applying for the U.S. Food and Drug Administration’s approval of LUMRYZ for any indication beyond narcolepsy. Additionally, the Federal Circuit lifted the portions of the Delaware Court's injunction that prohibited the Company from offering open-label extensions to trial participants using LUMRYZ and from initiating new clinical trials or studies with LUMRYZ for potential indications beyond narcolepsy.
| Item 9.01 | Exhibits. |
(d) Exhibits
| 99.1 | Press release issued by Avadel Pharmaceuticals plc on May 6, 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: May 6, 2025 | AVADEL PHARMACEUTICALS PLC | ||
| By: | /s/ Jerad G. Seurer | ||
| Name: | Jerad G. Seurer | ||
| Title: | General Counsel & Corporate Secretary | ||