Every 8-K that Aquestive Therapeutics, Inc. (AQST) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow AQST and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full AQST filings page.
Aquestive Therapeutics reported second quarter 2026 results with total revenues of $13.8 million, up from $10.0 million a year earlier, driven mainly by higher manufacture and supply revenue and increased license and royalty revenue. Manufacture and supply revenue rose to $11.9 million, while royalty-based products, including Sympazan, contributed to growth as manufacturing volumes increased to about 48 million doses from 37 million in the prior-year quarter.
GAAP performance weakened as the company recorded a net loss of $22.9 million versus $13.5 million last year, largely due to a $11.7 million one-time loss on extinguishment of 13.5% notes and higher selling, general and administrative expenses. However, non-GAAP adjusted EBITDA loss improved to $5.2 million from $9.3 million. Cash and cash equivalents were $98.5 million as of June 30, 2026, though the balance sheet showed a stockholders’ deficit of $56.6 million alongside substantial debt and royalty obligations.
Strategically, Aquestive completed the human factors and pharmacokinetic studies needed to address the FDA Complete Response Letter for Anaphylm and reaffirmed plans to resubmit the NDA in Q3 2026, seek ex‑U.S. approvals starting in late 2026, and continue advancing its AdrenaVerse™ epinephrine platform, including AQST‑108 for dermatologic indications. The company maintained its 2026 guidance for total revenue of $46–$50 million and non‑GAAP adjusted EBITDA loss of $35–$30 million.
Aquestive Therapeutics reported new human factors and pharmacokinetic data for Anaphylm™ (dibutepinephrine) sublingual film, supporting a planned resubmission of its New Drug Application for treatment of Type 1 allergic reactions, including anaphylaxis, in the third quarter of 2026. The company also furnished an investor presentation and a detailed press release describing these results.
In a 105-participant human factors validation study using revised packaging and instructions for use, median time to open the first pouch dropped to 3 seconds from 17 seconds in a prior study, while participants with difficulty opening the pouch fell from 26 of 166 to 1 of 105. Incorrect film placement decreased from 20 of 166 to 2 of 105, with no cases of chewing or removing the film. In a PK study, self-administered Anaphylm achieved a geometric mean Cmax of 391.7 pg/mL with a median Tmax of 12 minutes, comparable to clinician-administered Anaphylm and manual intramuscular epinephrine. Purposeful misplacement on top-of-tongue produced a geometric mean Cmax of 112.7 pg/mL, a median Tmax of 35 minutes, and clinically meaningful pharmacodynamic responses. No serious adverse events or discontinuations were reported, and the company is also advancing regulatory submissions for Anaphylm in Canada, the UK and the European Union.
Aquestive Therapeutics, Inc. reported the results of its 2026 Annual Meeting of Stockholders held on June 10, 2026. Stockholders elected three Class II directors — Gregory B. Brown, M.D., John S. Cochran, and Abigail L. Jenkins — to serve three-year terms until the 2029 annual meeting.
Stockholders also approved, on a non-binding advisory basis, the Company’s executive compensation program, with 37,798,609 votes for, 3,192,381 against, and 1,604,754 abstentions, plus 37,465,582 broker non-votes. In addition, they ratified the appointment of KPMG LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 78,804,323 votes for, 910,690 against, and 346,313 abstentions.
Aquestive Therapeutics reported a much stronger first quarter of 2026 and refinanced its capital structure to support its lead allergy drug, Anaphylm. Total revenue rose to $14.4 million from $8.7 million, driven by higher license, royalty, and manufacturing revenue. Net loss narrowed sharply to $8.1 million, or $0.07 per share, compared with a $22.9 million loss a year earlier, helped by lower R&D and SG&A expenses. Non-GAAP adjusted EBITDA loss improved to $1.7 million from $17.6 million. The company ended the quarter with $110.7 million in cash and reaffirmed 2026 guidance for revenue of $46–$50 million and non-GAAP adjusted EBITDA loss of $30–$35 million. Separately, Aquestive entered a new five-year $150 million term loan facility with Oaktree, including $55 million funded at closing to refinance $45 million of existing notes, interest-only payments until 2031 maturity, and additional tranches tied to FDA approval and sales milestones for Anaphylm.
Aquestive Therapeutics filed an 8-K after completing an in-person FDA Type A meeting on its Anaphylm™ (dibutepinephrine) sublingual film program for treating Type 1 allergic reactions, including anaphylaxis. The meeting provided preliminary FDA feedback on pharmacokinetic and human factors study designs and on revised packaging.
The company says it is incorporating the FDA’s comments into upcoming studies and plans to submit the human factors protocol for FDA review. Based on this interaction, Aquestive reaffirmed its plan to resubmit the Anaphylm New Drug Application in the third quarter of 2026 and is also advancing regulatory submissions in Canada and the European Union.
Aquestive Therapeutics is reshaping its legal leadership, appointing Thomas A. Zalewski as Chief Legal Officer and Chief Compliance Officer effective April 2, 2026, while Lori J. Braender steps down from those executive roles and continues as Corporate Secretary.
Braender will provide transition services and receive her current base salary through May 7, 2026, plus a pro rata 2026 bonus, 12 months of severance-style monthly payments equal to 1/12 of her prior base salary and target bonus, and 12 months of continued health and life insurance coverage. All of her unvested equity awards will fully vest on May 7, 2026, and options and similar awards will remain exercisable for at least five years or until their scheduled expirations.
For her ongoing non-executive role, Braender will earn a base salary of $15,000 per month and remain eligible for senior executive benefit plans. To induce Zalewski to join, the company will grant 100,000 Restricted Stock Units and 75,000 stock options under its 2022 Equity Inducement Plan, vesting over three years, with the options carrying a ten-year term and an exercise price set at the closing price on May 8, 2026.
Aquestive Therapeutics reported fourth-quarter 2025 revenue of $13.0 million, up from $11.9 million, and full-year 2025 revenue of $44.5 million, down from $57.6 million after a prior-year deferred revenue benefit. Full-year GAAP net loss widened to $83.8 million from $44.1 million, driven mainly by higher selling, general and administrative costs, including about $14.3 million of one-time legal expenses and increased Anaphylm launch preparation spending.
The company ended 2025 with $121.2 million in cash and cash equivalents and guided 2026 revenue to $46–$50 million and non-GAAP adjusted EBITDA loss to $30–$35 million. Aquestive received an FDA Complete Response Letter for Anaphylm in January 2026 focused on human factors and requested a pharmacokinetic study, and now plans to resubmit its NDA in the third quarter of 2026. To support its RTW revenue-sharing arrangement and liquidity, Aquestive extended the Anaphylm marketing approval deadline to June 30, 2027, agreed to issue RTW a warrant for up to 375,000 shares at $4.00 per share expiring in 2029, and obtained a commitment from RTW-affiliated funds to purchase at least $5 million of common stock over a 90-day period.
Aquestive Therapeutics furnished an investor presentation outlining its strategy and pipeline, highlighted by Anaphylm, a sublingual epinephrine film for severe allergies that received a Complete Response Letter from the FDA on January 30, 2026. The company expects to resubmit the New Drug Application for Anaphylm in Q3 2026 and is planning for a potential U.S. launch in 2027 if approved.
The presentation emphasizes a diversified portfolio including Libervant for acute repetitive seizures and AQST-108, a topical epinephrine gel initially targeting alopecia areata. Aquestive reports finishing 2025 with $121 in cash and cash equivalents and describes itself as well-capitalized to complete required Anaphylm work in 2026. Management also cites more than $1.5 billion in potential peak annual net sales from pipeline assets and key upcoming clinical, regulatory and commercialization milestones through 2027.
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.
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.
Aquestive Therapeutics (AQST) furnished an investor presentation via Form 8-K. The company provided Q3 Earnings Supplemental Materials as Exhibit 99.1 under Item 7.01 (Regulation FD) on November 6, 2025. The materials are incorporated by reference into Item 7.01 and are posted on the Investors section of its website.
The company stated that the information in Item 7.01 (including Exhibit 99.1) is furnished, not filed, and is not subject to Section 18 liabilities or automatically incorporated into Securities Act or Exchange Act filings.
Aquestive Therapeutics (AQST) furnished an 8-K announcing its third-quarter 2025 financial results and recent business updates. The company attached a press release and financial schedules as Exhibit 99.1 and provided an investor presentation as Exhibit 99.2.
The materials are furnished, not filed, under Items 2.02 and 7.01. The investor presentation is also available on the company’s website under Investors > Events and Presentations.
Aquestive Therapeutics, Inc. filed a current report describing new intellectual property protection for its allergy-treatment candidate. The company announced that the United States Patent and Trademark Office has issued two additional U.S. patents related to Anaphylm™, its novel epinephrine prodrug sublingual film. The report also notes that a detailed press release describing these patents is provided as Exhibit 99.1.
Aquestive Therapeutics, Inc. furnished an investor presentation for use in meetings with institutional investors, analysts and others. The presentation, dated October 2025, is attached as Exhibit 99.1 and is also available in the Investors section of the company’s website.
The information is being provided under a current report and is designated as “furnished,” meaning it is not subject to the liability provisions of Section 18 of the Exchange Act and is not automatically incorporated into other securities law filings unless specifically referenced.
Aquestive Therapeutics, Inc. furnished a current report to share its latest investor presentation used at the H.C. Wainwright 27th Annual Global Investor Conference held on September 8, 2025. The presentation is attached as Exhibit 99.1 and may also be viewed on the company’s website. The information in this investor deck is being provided under a Regulation FD disclosure item and is expressly stated as “furnished” rather than “filed”, meaning it is not subject to liability under Section 18 of the Exchange Act and is not automatically incorporated into other securities law filings unless specifically referenced.
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.
Aquestive Therapeutics entered a purchase and sale agreement with funds managed by RTW Investments LP under which the Purchaser will pay the Company $75 million in exchange for a true sale of assigned interests related to U.S. sales of Anaphylm, subject to FDA approval by a specified date, the refinancing of the Company’s existing 13.5% Senior Secured Notes and customary closing conditions. Revenue-share payments begin in the first fiscal quarter after the first U.S. commercial sale following closing and are tiered between 7.5% and 1.0% of Net Sales, with a 9.5% rate for a subsequent calendar year if Net Sales do not meet a specified level beginning in 2027.
Payments to the Purchaser will cease when the Purchaser has received $187.5 million by December 31, 2035, or $225 million thereafter. The Purchase Agreement includes customary affirmative and negative covenants, including limitations on incurrence of indebtedness until the Purchaser attains a specified return. A press release describing the transaction is attached as Exhibit 99.1.
Aquestive Therapeutics announced a press release reporting its reported financial results for the second quarter ended June 30, 2025 and provided a business update. The press release and accompanying financial schedules are included as Exhibit 99.1 and are referenced in Item 2.02 of the Current Report.
The company also furnished investor presentations and a corporate presentation as Exhibits 99.2 and 99.3, stating those materials are available on the Events and Presentations page of its website. The filing clarifies that the disclosed materials are furnished and shall not be deemed to be "filed" for purposes of Section 18 of the Exchange Act.
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.