Avadel Pharmaceuticals plc filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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| Item 7.01 | Regulation FD Disclosure. |
On October 31, 2024, Avadel Pharmaceuticals plc (the “Company”) issued a press release titled “Avadel Pharmaceuticals Announces Favorable Ruling in Administrative Procedure Act Litigation.” 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 October 30, 2024, the United States District Court for the District of Columbia (the “Court”) ruled in favor of the U.S. Food and Drug Administration (“FDA”) in a suit brought by Jazz Pharmaceuticals Inc. (“Jazz”) under the Administrative Procedure Act regarding the FDA’s approval of LUMRYZTM. As a result, the FDA’s approval of LUMRYZ is upheld based on its determination that LUMRYZ is clinically superior to Jazz’s twice-nightly oxybate products.
| Item 9.01 | Exhibits. |
(d) Exhibits
| 99.1 | Press release issued by Avadel Pharmaceuticals plc on October 31, 2024, 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: October 31, 2024 | AVADEL PHARMACEUTICALS PLC | ||
| By: | /s/ Jerad G. Seurer | ||
| Name: | Jerad G. Seurer | ||
| Title: | General Counsel & Corporate Secretary | ||