FDA to review Aquestive (AQST) Anaphylm without advisory panel before Jan 2026

Rhea-AI Filing Summary

Aquestive Therapeutics reported that the U.S. Food and Drug Administration informed the company an advisory committee meeting is not required for its Anaphylm™ (dibutepinephrine) Sublingual Film candidate. The Prescription Drug User Fee Act target action date for Anaphylm remains January 31, 2026.

Insights

Biotech regulatory & pipeline analyst

FDA skipping an advisory panel simplifies Anaphylm’s review but does not change its January 31, 2026 action date.

The disclosure centers on Anaphylm, Aquestive’s sublingual film formulation of dibutepinephrine. The U.S. Food and Drug Administration has told the company that an advisory committee meeting is not required for this review, which can streamline the path to a final decision.

The Prescription Drug User Fee Act target action date for Anaphylm remains January 31, 2026. No advisory committee means investors may see fewer public debate signals before that date, so expectations will rely more on future written FDA interactions or company updates.

This update does not guarantee approval; it simply outlines the current review path and timing. Subsequent company communications about labeling discussions, information requests, or post-marketing requirements, if any are disclosed, will provide additional insight into how the FDA views Anaphylm’s risk–benefit profile.

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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): September 4, 2025

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 September 4, 2025, Aquestive Therapeutics, Inc. (the “Company”) issued a press release announcing the U.S. Food and Drug Administration has informed the Company that an advisory committee meeting is not required for Anaphylm™ (dibutepinephrine) Sublingual Film. The Prescription Drug User Fee Act target action date for Anaphylm remains January 31, 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 information in this Item 7.01 (including Exhibit 99.1) 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 September 4, 2025

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: September 4, 2025			Aquestive Therapeutics, Inc.
			By:			/s/ A. Ernest Toth, Jr
						Name: A. Ernest Toth, Jr.
						Title: Chief Financial Officer

FAQ

What did the FDA communicate to Aquestive Therapeutics (AQST) about Anaphylm?

The FDA informed Aquestive Therapeutics that an advisory committee meeting is not required for Anaphylm. This means the agency plans to complete its review without convening an external expert panel, which can streamline the regulatory process while leaving the final approval decision unchanged.

What is the PDUFA target action date for Aquestive Therapeutics’ Anaphylm (AQST)?

The PDUFA target action date for Anaphylm remains January 31, 2026. This is the date by which the FDA aims to complete its review. The recent update about not holding an advisory committee meeting does not alter this scheduled action date.

Does the absence of an FDA advisory committee guarantee approval for Anaphylm by Aquestive (AQST)?

The absence of an advisory committee does not guarantee Anaphylm’s approval. It only indicates the FDA does not currently see the need for external expert discussion. The agency will still independently assess safety, efficacy, and overall risk–benefit before its January 31, 2026 target date.

What product is Aquestive Therapeutics (AQST) developing under the name Anaphylm?

Anaphylm is described as a dibutepinephrine sublingual film product candidate. It is being reviewed by the FDA, with a target action date of January 31, 2026. The recent update concerns the review process, specifically that no advisory committee meeting will be held.

How did Aquestive Therapeutics (AQST) disclose the FDA update on Anaphylm?

Aquestive disclosed the FDA update in a current report and an accompanying press release. The company stated that the FDA will not require an advisory committee meeting for Anaphylm and reiterated the PDUFA target action date of January 31, 2026 in that communication.

Where can investors find the full press release on Aquestive’s Anaphylm update (AQST)?

The full press release is included as Exhibit 99.1 to the current report. It is incorporated into the communication under Item 7.01, providing additional context on the FDA’s decision not to hold an advisory committee meeting and confirming the PDUFA action date.