Aquestive Therapeutics Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits
$AQST
Biotechnology: Pharmaceutical Preparations
Health Care
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): January 9, 2026
(Exact name of Registrant as specified in its charter)
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
(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)
________________________________________________________________________________________________________________________
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Item 8.01 | Other Events. | ||||
On January 9, 2026, Aquestive Therapeutics, Inc. (the “Company”) issued a press release announcing the receipt of a notice from the U.S. Food and Drug Administration (FDA) that, as part of its ongoing review, the FDA had identified deficiencies in the New Drug Application (NDA) submitted by the Company for its product candidate, Anaphylm™ (epinephrine) Sublingual Film, for the treatment of severe allergic reactions, including anaphylaxis, that preclude discussion of labeling and post-marketing commitments for Anaphylm. The notification did not specify the deficiencies identified by the FDA and stated that the notification does not reflect a final decision on the pending NDA by the FDA and that the FDA’s review of the NDA is ongoing. The Company is working to understand and resolve the concerns of the FDA prior to the scheduled PDUFA goal date of January 31, 2026. The Company stated in the press release attached hereto that it continues to believe that Anaphylm represents a major step forward for people living with severe allergies, however, this development could result in a delay of the possible FDA approval of the NDA for Anaphylm. The Company also reported that the Company is continuing to advance its global strategy for Anaphylm with the initiation of regulatory engagement in Canada, Europe and the United Kingdom executed in 2025, and plans to seek regulatory approval of Anaphylm in Canada and Europe in 2026. The Company stated that, with a recent completed equity raise by the Company, and the current cash position of the Company, the Company believes that it has the necessary capital to execute on the Company’s current long-term strategy.
The Company also provided an update on its business stating that the Company had approximately $120 million in cash and cash equivalents as of December 31, 2025.
A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated into this Item 8.01 by reference.
Item 9.01 | Financial Statements and Exhibits. | ||||
(d) Exhibits.
| Exhibit Number | Description | |||||||
| Aquestive Therapeutics, Inc. Press Release, dated January 9, 2026 | ||||||||
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: January 9, 2026 | Aquestive Therapeutics, Inc. | |||||||
| By: | /s/ A. Ernest Toth, Jr | |||||||
| Name: A. Ernest Toth, Jr. | ||||||||
| Title: Chief Financial Officer | ||||||||