Current Report Filing (8-k)
19 7월 2022 - 8:11PM
Edgar (US Regulatory)
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0001012477
2022-07-19
2022-07-19
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iso4217:USD
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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): July 19, 2022
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 to the registrant under any of the following provisions:
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¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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¨ |
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 7.01 Regulation FD Disclosure.
On July 19, 2022, Avadel Pharmaceuticals plc (the “Company”)
issued a press release titled “Avadel Pharmaceuticals Announces Tentative Approval of LUMRYZ™ (sodium oxybate) extended-release
oral suspension.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information furnished under this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for 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 it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On July 18, 2022, the Company received tentative approval from the
U.S. Food and Drug Administration (the “FDA”) of its lead product candidate, LUMRYZ, also known as FT218. The tentative approval
indicates that FT218 has met all required quality, safety and efficacy standards necessary for approval in the United States. The final
approval of FT218 is pending disposition of U.S. Patent No. 8,731,963 which is listed in FDA’s Orange Book.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
Cautionary Note Regarding Forward-Looking Statements
Statements contained in this Current Report on Form 8-K regarding
matters that are not historical facts are “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 the Company’s future
expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking
statements include, but are not limited to, the timing and receipt of the FDA’s final approval of the FT218 NDA, if at all.
Any forward-looking statements in this Current Report on Form 8-K
are based on estimates and assumptions that are made within the bounds of the Company’s knowledge of its business and operations
and that it considers 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, 2021, which was filed with the Securities
and Exchange Commission (SEC) on March 16, 2022, 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.
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: July 19, 2022 |
AVADEL PHARMACEUTICALS PLC |
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By: |
/s/ Jerad G. Seurer |
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Name: Jerad G. Seurer |
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Title: General Counsel & Corporate Secretary |
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