Current Report Filing (8-k)
June 25 2021 - 5:03AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (date of earliest event reported): June
24, 2021
Adial Pharmaceuticals, Inc.
(Exact name of registrant as specified in charter)
Delaware
(State or other jurisdiction of incorporation)
001-38323
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82-3074668
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(Commission File Number)
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(IRS Employer Identification No.)
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1001 Research Park Blvd., Suite 100
Charlottesville, VA 22911
(Address of principal executive offices and zip
code)
(434) 422-9800
(Registrant’s telephone number including area
code)
(Former Name and Former Address)
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of 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(b) 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))
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Securities registered pursuant to Section 12(b) of the Act:
Title of each class
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Trading Symbols
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Name of each exchange on which registered
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Common Stock
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ADIL
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NASDAQ
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Warrants
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ADILW
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NASDAQ
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Indicate by check mark whether the registrant is an
emerging growth company as defined in 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 þ
If an emerging growth company, indicate by checkmark
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
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Regulation FD Disclosure.
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On June 24, 2021, Adial Pharmaceuticals,
Inc. (the “Company”) issued a press release providing information regarding its application for a Fast Track Designation for
its lead product candidate AD04 for the treatment of Alcohol Use Disorder (AUD) in pediatric patients and adult patients with Alcoholic
Liver Disease (ALD) with select polymorphisms of the serotonin transporter and receptor genes. The Company reported that on June 23, 2021,
it received notice from the FDA that its request for Fast Track Designation has been denied at this time. While the FDA did acknowledge
the unmet medical needs of adolescents and ALD patients with AUD, the FDA stated in its letter that the Company has not yet demonstrated
that the product shows potential to address an unmet medical need in the situation where other treatments are available. Additionally,
the FDA stated additional information would be required regarding how AD04 might compare to other therapies if the Company desires further
consideration. Based on this feedback, the Company will review the additional requirements and data requested by the FDA for a Fast Track
Designation.
A copy of the press release is
furnished as Exhibit 99.1 to this Report on Form 8-K. The information contained in the press release is being furnished to the Securities
and Exchange Commission (the “Commission”) and shall not be deemed incorporated by reference into any of the Registrant’s
registration statements or other filings with the Commission.
The information in this Item 7.01,
and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or
Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with the
U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation
language in such filing.
Item 8.01 – Other Events.
On June 24, 2021, the Company
issued a press release providing information regarding its application for a Fast Track Designation for its lead product candidate AD04
for the treatment of Alcohol Use Disorder (AUD) in pediatric patients and adult patients with Alcoholic Liver Disease (ALD) with select
polymorphisms of the serotonin transporter and receptor genes. The Company reported that on June 23, 2021, it received notice from the
FDA that its request for Fast Track Designation has been denied at this time. While the FDA did acknowledge the unmet medical needs of
adolescents and ALD patients with AUD, the FDA stated in its letter that the Company has not yet demonstrated that the product shows
potential to address an unmet medical need in the situation where other treatments are available. Additionally, the FDA stated additional
information would be required regarding how AD04 might compare to other therapies if the Company desires further consideration. Based
on this feedback, the Company will review the additional requirements and data requested by the FDA for a Fast Track Designation.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following exhibit is furnished with this Current
Report on Form 8-K:
SIGNATURES
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.
Dated: June 24, 2021
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ADIAL PHARMACEUTICALS, INC.
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By:
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/s/ William B. Stilley, III
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Name:
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William B. Stilley
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Title:
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President and Chief Executive Officer
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