FDA flags deficiencies in Aquestive Therapeutics (NASDAQ: AQST) Anaphylm NDA

Rhea-AI Filing Summary

Aquestive Therapeutics disclosed that the U.S. FDA has identified deficiencies in its New Drug Application for Anaphylm, an epinephrine sublingual film for severe allergic reactions, including anaphylaxis. The FDA indicated that these deficiencies, which were not specified, currently prevent discussions about labeling and post‑marketing commitments, and it stated that its review is ongoing and no final decision has been made.

The company is working to understand and address the FDA’s concerns ahead of the scheduled PDUFA goal date of January 31, 2026, but noted this development could delay a possible approval of the Anaphylm NDA. Aquestive also highlighted progress on its global strategy, having begun regulatory engagement in Canada, Europe and the United Kingdom in 2025 and planning to seek approvals in Canada and Europe in 2026. It reported approximately $120 million in cash and cash equivalents as of December 31, 2025, and believes this provides sufficient capital to pursue its long-term strategy.

Positive

• None.

Negative

• FDA identified deficiencies in Anaphylm’s NDA that currently block labeling discussions and, by the company’s own description, could delay possible FDA approval.

Insights

Biopharma regulatory analyst

FDA-identified deficiencies create approval timing risk for Anaphylm.

The update shows that the FDA has found unspecified deficiencies in the New Drug Application for Anaphylm, Aquestive’s epinephrine sublingual film for severe allergic reactions, including anaphylaxis. Because these issues currently prevent labeling and post‑marketing discussions, they represent a meaningful hurdle in the review process, even though the FDA emphasized that its evaluation is ongoing and no final decision has been reached.

This situation introduces clear risk around the planned PDUFA goal date of January 31, 2026, as the company itself acknowledges the potential for a delay in possible approval. At the same time, management reports approximately $120 million in cash and cash equivalents as of December 31, 2025 and expresses confidence in having enough capital to execute its long‑term strategy, including plans to seek Anaphylm approvals in Canada and Europe in 2026. The ultimate impact will depend on whether the company can satisfactorily address the FDA’s concerns within the existing review timeline.

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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

Aquestive Therapeutics, Inc.

(Exact name of Registrant as specified in its charter)

Delaware			001-38599			82-3827296
(State or other jurisdiction of incorporation)			(Commission File Number)			(I.R.S. Employer Identification No.)

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))

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

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 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
99.1						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

FAQ

What did Aquestive Therapeutics (AQST) announce about the FDA review of Anaphylm?

Aquestive reported that the U.S. FDA identified deficiencies in the New Drug Application for Anaphylm, its epinephrine sublingual film, which currently prevent discussion of labeling and post‑marketing commitments, while the FDA’s review remains ongoing and no final decision has been made.

Could the FDA-identified deficiencies delay approval of Anaphylm for Aquestive Therapeutics (AQST)?

Yes. The company stated that the deficiencies identified by the FDA in the Anaphylm NDA could result in a delay of the possible FDA approval for Anaphylm, even though the review is still in progress.

What is the PDUFA goal date for Aquestive Therapeutics’ (AQST) Anaphylm NDA?

The company noted that it is working to address the FDA’s concerns prior to the scheduled PDUFA goal date of January 31, 2026 for the Anaphylm New Drug Application.

How much cash does Aquestive Therapeutics (AQST) report having?

Aquestive stated that it had approximately $120 million in cash and cash equivalents as of December 31, 2025, following a recently completed equity raise.

What are Aquestive Therapeutics’ (AQST) global regulatory plans for Anaphylm?

The company reported that it initiated regulatory engagement for Anaphylm in Canada, Europe and the United Kingdom in 2025 and plans to seek regulatory approval in Canada and Europe in 2026.

Does Aquestive Therapeutics believe it has enough capital to pursue its strategy?

Yes. Aquestive stated that, with its recently completed equity raise and current cash position, it believes it has the necessary capital to execute on its current long‑term strategy.