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 2, 2023
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 1 920 1000
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 of 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 |
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. ¨
Item 8.01 | Other Events. |
On March 1, 2023, Avadel Pharmaceuticals plc submitted an amendment to its New Drug Application to the U.S. Food and Drug Administration (“FDA”) requesting final approval for LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. The submission follows the FDA submission by Jazz Pharmaceuticals of February 28, 2023, requesting delisting of U.S. Patent No. 8,731,963 from FDA’s Orange Book pursuant to the United States Court of Appeals for the Federal Court decision of February 24, 2023, affirming the previous ruling from the United States District Court for the District of Delaware, ordering such delisting.
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: March 2, 2023 | AVADEL PHARMACEUTICALS PLC | ||
By: | /s/ Jerad G. Seurer | ||
Name: | Jerad G. Seurer | ||
Title: | General Counsel & Corporate Secretary |