8-K 1 aacceptanceoflibervantndar.htm 8-K Document


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): July 19, 2021
Aquestive Therapeutics, Inc.
(Exact name of Registrant as specified in its charter)
Delaware001-3859982-3827296
(State or Other Jurisdiction of Incorporation or Organization)
(Commission File Number)(I.R.S. Employer Identification No.)
(Commission

30 Technology Drive
Warren, NJ 07059
(908) 941-1900
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

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))

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. ☐

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001 per share
AQST
Nasdaq Global Market





Item 8.01 Other Events.

On July 19, 2021, Aquestive Therapeutics, Inc. (the “Company”) issued a press release announcing the U.S. Food and Drug Administration has accepted for filing the resubmission of the New Drug Application for Libervant™ (diazepam) Buccal Film for the management of seizure clusters. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and incorporated into this Item 8.01 by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit NumberDescription
Press Release, dated July 19, 2021, the U.S. Food and Drug Administration has accepted for filing the resubmission of the New Drug Application for Libervant™ (diazepam) Buccal Film for the management of seizure clusters.


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: July 19, 2021Aquestive Therapeutics, Inc.
By:/s/ A. Ernest Toth, Jr.
Name:
A. Ernest Toth, Jr.
Title:
Chief Financial Officer
(Principal Financial Officer)