Welcome to our dedicated page for Aquestive Therapeutics SEC filings (Ticker: AQST), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Aquestive Therapeutics, Inc. (NASDAQ: AQST) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. Aquestive uses current reports on Form 8‑K to announce material events such as quarterly financial results, new or updated investor presentations, patent developments for its Anaphylm™ epinephrine sublingual film, and financing agreements tied to future product revenues.
Through these filings, investors can review how Aquestive describes the status of its late-stage product candidate Anaphylm for severe allergic reactions, including anaphylaxis, and its earlier-stage epinephrine prodrug topical gel AQST‑108 for dermatologic conditions. Form 8‑K filings also reference press releases that discuss the FDA review process for the Anaphylm New Drug Application, regulatory interactions in Canada and Europe, and key milestones such as the FDA’s decision not to require an advisory committee meeting.
In addition, Aquestive’s 8‑K filings outline material definitive agreements, including a purchase and sale agreement with funds managed by RTW Investments LP that grants tiered revenue share rights on future U.S. net sales of Anaphylm, subject to conditions like FDA approval and debt refinancing. These documents describe covenants that affect the company’s ability to incur indebtedness and other obligations that may influence its capital structure.
On Stock Titan, users can view these filings as they are made available from EDGAR and use AI-powered summaries to understand the key points in lengthy documents. This includes highlights from earnings-related 8‑Ks, supplemental investor materials, and other disclosures that provide context on Aquestive’s financial condition, risk factors, product pipeline, and strategic initiatives. Filings related to insider activity, annual reports on Form 10‑K, quarterly reports on Form 10‑Q, and additional 8‑Ks can all be analyzed with AI tools to quickly identify information relevant to AQST’s regulatory and business profile.
Greenhawt Matthew J. reported acquisition or exercise transactions in this Form 4 filing.
Aquestive Therapeutics Chief Medical Officer Matthew J. Greenhawt received new equity awards. He was granted a non-qualified stock option for 50,000 shares of Common Stock at $4.29 per share, expiring on March 9, 2036. The option vests in three annual installments of 25%, 25%, and 50%.
He also received 75,000 shares of restricted Common Stock at no cost, vesting on the same 25%, 25%, and 50% schedule. Following these grants, he holds 75,000 shares of Common Stock directly, 50,000 option shares directly, and 2,000 shares indirectly through his spouse.
Aquestive Therapeutics, Inc. filed an initial ownership report for Chief Medical Officer Matthew J. Greenhawt. The filing shows indirect beneficial ownership of 2,000 shares of Common Stock held by his spouse. This Form 3 records an existing position and does not report any new purchase or sale.
Aquestive Therapeutics is a specialty pharmaceutical company focused on oral film delivery technologies, especially for CNS and allergy indications. It reported licensed product revenue of $44,545 in 2025 and $57,561 in 2024. As of June 30, 2025, non‑affiliate market value of common stock was about $291.6 million, with 122,045,049 shares outstanding as of March 2, 2026.
The lead epinephrine candidate Anaphylm received an FDA Complete Response Letter on January 30, 2026 citing human‑factors and labeling issues, not CMC or PK data. The company plans new human‑factors and PK studies and targets NDA resubmission in Q3 2026 while also pursuing EMA and Canadian submissions.
In epilepsy, buccal diazepam film Libervant had its approval for patients aged 2–5 years vacated by a U.S. District Court decision favoring a competitor’s orphan‑drug exclusivity, converting Libervant to tentative approval and halting U.S. marketing. Aquestive retains ex‑U.S. rights via partners and continues to develop its AdrenaVerse epinephrine prodrug platform, including topical gel AQST‑108.
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) reported an insider equity award to its Chief Development Officer. On 11/10/2025, the officer acquired 50,000 shares of Common Stock at $0, described as restricted stock that vests over three annual installments (25%, 25%, 50%). The filing also shows a non-qualified stock option for 50,000 shares at an exercise price of $5.58, granted on 11/10/2025 and expiring on 11/10/2035, with the same 25/25/50 vesting schedule.
Aquestive Therapeutics (AQST) reported an insider ownership update. An officer serving as Chief Development Officer filed a Form 3 pursuant to Section 16(a). The filing indicates it was filed by one reporting person and lists the date of event as 11/03/2025. In the remarks, the filer states: No securities are beneficially owned. The document is signed by /s/ Lori Braender, as Attorney-In-Fact on behalf of the reporting person.
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.