FDA issues Complete Response Letter on Aquestive (AQST) Anaphylm allergy film

Rhea-AI Filing Summary

Aquestive Therapeutics reported that the U.S. Food and Drug Administration issued a Complete Response Letter on January 30, 2026 for its New Drug Application for Anaphylm (dibutepinephrine) sublingual film to treat Type I allergic reactions, including anaphylaxis, in patients weighing at least 30kg. The company states that FDA-identified deficiencies are limited to packaging and administration and believes these can be resolved, with a resubmission targeted as early as the third quarter of 2026.

Aquestive is also advancing a global strategy for Anaphylm, having begun regulatory engagement in Canada, Europe and the United Kingdom in 2025, and it plans to seek regulatory approvals in Canada and Europe in 2026. The company furnished a press release and investor presentation as exhibits to provide additional details.

Positive

• None.

Negative

• FDA Complete Response Letter delays Anaphylm approval: The U.S. Food and Drug Administration issued a Complete Response Letter for the Anaphylm New Drug Application, meaning it was not approved in its current form and potentially delaying commercialization.

Insights

Biopharma regulatory analyst

FDA’s Complete Response Letter delays Anaphylm but issues are limited to packaging and administration.

The FDA issued a Complete Response Letter for Aquestive’s Anaphylm NDA covering treatment of Type I allergic reactions and anaphylaxis in patients of at least 30kg. A CRL means the application is not approved in its current form, which is a setback for the program.

The company reports that deficiencies were limited to packaging and administration, suggesting no additional clinical efficacy or safety studies are described in this excerpt. Aquestive believes it can resolve these points and aims to resubmit as early as the third quarter of 2026, indicating a defined regulatory path forward.

Aquestive is also pursuing regulatory engagement in Canada, Europe and the United Kingdom, with plans to seek approvals in Canada and Europe in 2026. Actual outcomes will depend on successfully addressing FDA feedback and on decisions by non-U.S. regulators after their own reviews.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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 30, 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 7.01 Regulation FD Disclosure.

On February 2, 2026, Aquestive Therapeutics, Inc. (the “Company”) issued a press release announcing that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 30, 2026, for the New Drug Application (NDA) seeking approval of Anaphylm™ (dibutepinephrine) Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more (approximately 66 pounds). Deficiencies were limited to packaging and administration. The Company believes that it can rapidly resolve these deficiencies and expects to resubmit as early as the third quarter of 2026. 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. A copy of the Company’s press release is attached as Exhibit 99.1 to this Current Report and incorporated in this Item 7.01 by reference.

The Company is also furnishing this Current Report on Form 8-K in connection with the disclosure of information, in the form of an investor presentation, to be given at meetings with institutional investors, analysts and others. This information may be amended or updated at any time and from time to time through another Current Report on Form 8-K, a later Company filing or other means. A copy of the Company’s investor presentation is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference. The investor presentation is available on the Events and Presentations page in the Investors section of the Company’s website located at www.aquestive.com, although the Company reserves the right to discontinue that availability at any time.

The information in this Item 7.01 (including Exhibits 99.1 and 99.2) shall not be deemed to be “filed” for purposes of, or otherwise subject to the liabilities of, Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number						Description
99.1						Aquestive Therapeutics, Inc. Press Release, dated February 2, 2026
99.2						Aquestive Therapeutics Complete Response Letter Supplemental Material, dated February 2, 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: February 2, 2026			Aquestive Therapeutics, Inc.
			By:			/s/ A. Ernest Toth, Jr
						Name: A. Ernest Toth, Jr.
						Title: Chief Financial Officer

FAQ

What did the FDA decide about Aquestive Therapeutics (AQST) Anaphylm NDA?

The FDA issued a Complete Response Letter on January 30, 2026 for Aquestive’s Anaphylm New Drug Application. This means the application was not approved as submitted and must be revised to address the FDA’s cited deficiencies before approval is reconsidered.

What issues did the FDA raise regarding Anaphylm in Aquestive’s 8-K?

According to Aquestive, the FDA’s deficiencies were limited to packaging and administration for Anaphylm. The filing does not describe additional clinical or safety issues, and the company believes these packaging and administration points can be resolved relatively quickly.

When does Aquestive Therapeutics plan to resubmit the Anaphylm NDA?

Aquestive states it expects to resubmit the Anaphylm New Drug Application as early as the third quarter of 2026. This planned timing depends on resolving the FDA’s packaging and administration deficiencies identified in the Complete Response Letter issued January 30, 2026.

What is Anaphylm and who is it intended to treat, according to Aquestive?

Anaphylm is described as a dibutepinephrine sublingual film for treating Type I allergic reactions, including anaphylaxis. It is intended for patients weighing 30kg or more, which the filing equates to approximately 66 pounds, covering many pediatric and adult patients.

What global regulatory plans does Aquestive have for Anaphylm outside the United States?

Aquestive is advancing a global strategy for Anaphylm, noting regulatory engagement began in Canada, Europe and the United Kingdom in 2025. The company plans to seek regulatory approval of Anaphylm in Canada and Europe in 2026, expanding beyond the U.S. market effort.

What additional materials did Aquestive furnish with this 8-K about the Anaphylm CRL?

Aquestive attached a press release as Exhibit 99.1 and Complete Response Letter supplemental material as Exhibit 99.2. The investor presentation, also furnished as Exhibit 99.2, is available on the company’s website’s investor section, though availability may be discontinued at any time.