Aquestive advances Anaphylm regulatory path with Canada & EU steps

Rhea-AI Filing Summary

In an 8-K filed on July 15, 2025, Aquestive Therapeutics (AQST) disclosed that Health Canada has granted the company a formal meeting to discuss a planned New Drug Submission (NDS) for its lead candidate, Anaphylm™ (epinephrine) Sublingual Film. The company also confirmed it has submitted an initial briefing book to the European Medicines Agency (EMA) and intends to file a Marketing Authorization Application (MAA) "as soon as possible."

Although the filing contains no financial figures, the regulatory milestones could significantly expand Anaphylm’s addressable market beyond the U.S., potentially accelerating future revenue once approvals are secured.

Positive

• Health Canada granted a formal meeting, marking a concrete step toward an NDS for Anaphylm.
• EMA initial briefing book submitted, indicating progress toward a European MAA and broader market reach.

Negative

• No regulatory submissions have been accepted or approved yet; commercial timing and revenue impact remain uncertain.

Insights

Biopharma Regulatory Analyst

TL;DR: Positive regulatory momentum; early but important steps toward Canadian and EU approvals.

The granted Health Canada meeting is an essential precursor to a formal NDS, signalling agency engagement and increasing the probability of a smooth submission process. Simultaneously, the EMA briefing book submission demonstrates parallel progress in Europe, shortening time to potential market entry. While approvals are not guaranteed, dual-region advancement lowers geographic risk concentration and enhances the product’s strategic value.

Equity Research Analyst

TL;DR: Incremental positive; no revenue impact until approvals materialize.

From an investor standpoint, the disclosure is constructive but not yet transformative. The lack of financial guidance or timelines tempers immediate valuation impact, yet regulatory traction supports the long-term bullish thesis on Anaphylm’s commercial potential.

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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): July 15, 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 8.01 Other Events

On July 15, 2025, Aquestive Therapeutics, Inc. (the “Company”) issued a press release announcing Health Canada has granted the Company a meeting to discuss Aquestive’s planned New Drug Submission (NDS) for Anaphylm™ (epinephrine) Sublingual Film in Canada. In addition, the Company has submitted an initial briefing book to the European Medicines Agency (EMA). The Company plans to submit a Marketing Authorization Application (MAA) to the EMA as soon as possible. A copy of the Company’s press release is attached as Exhibit 99.1 to this Current Report and incorporated in 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 July 15, 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: July 15, 2025			Aquestive Therapeutics, Inc.
			By:			/s/ A. Ernest Toth, Jr
						Name: A. Ernest Toth, Jr.
						Title: Chief Financial Officer

FAQ

What did Aquestive (AQST) announce in its July 15, 2025 8-K?

The company reported that Health Canada granted a meeting to discuss an NDS for Anaphylm and that an EMA briefing book has been submitted.

What is Anaphylm, and why is it important to AQST?

Anaphylm is a sublingual epinephrine film targeting severe allergic reactions; regulatory progress could open significant new markets.

Has Health Canada accepted an NDS for Anaphylm?

Not yet; the agency has granted a meeting, which precedes a formal NDS submission.

What progress has AQST made with the European Medicines Agency?

AQST has submitted an initial briefing book and plans to file an MAA as soon as possible.

Did the filing include any financial results or guidance?

No, the 8-K focused solely on regulatory developments without disclosing financial data.

How might these regulatory steps affect AQST’s market opportunity?

Successful approvals in Canada and the EU would expand Anaphylm’s geographic reach and potential revenue base.