SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934
of report (Date of earliest event reported): March 1, 2021 (
(Exact Name of Registrant as Specified in its Charter)
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Securities registered pursuant to Section 12(b) of the Act:
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Ordinary Shares, nominal value $0.01 per share**
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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, 2021, Avadel Pharmaceuticals plc (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has accepted the Company’s New Drug Application (“NDA”) for its product candidate, FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The FDA set a Prescription Drug User Fee Act goal date of October 15, 2021 for the completion of its review of the NDA. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
|99.1||Press release issued by the Company on March 1, 2021.|
|104||Cover Page Interactive Data File (embedded with the Inline XBRL document).|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|AVADEL PHARMACEUTICALS PLC|
|Date: March 1, 2021||By:||/s/ Jerad G. Seurer|
|Name:||Jerad G. Seurer|
|Title:||Vice President, Legal Affairs & Corporate Secretary|