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.
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.
Aquestive Therapeutics reported Q3 2025 results, showing revenue of $12.8 million and a net loss of $15.4 million. Year-to-date revenue was $31.5 million with a net loss of $51.9 million as the company continued to invest in R&D and commercialization.
Cash and cash equivalents were $129.1 million as of September 30, 2025. The capital position was bolstered by a public offering completed on August 14, 2025 for 21.25 million shares at $4.00 per share, generating $79.9 million in net proceeds, and by 7.46 million shares sold under the ATM program year-to-date for $21.3 million in net proceeds. Shares outstanding were 121,658,113 at quarter-end and 122,003,113 as of November 3, 2025.
Manufacture and supply revenue rose year over year in Q3 to $11.5 million, while license and royalty revenue declined due to prior year one-time deferred revenue recognition. Selling, general and administrative expenses increased to $15.3 million in the quarter. Customer concentration remained high, with Indivior representing approximately 72% of nine-month 2025 revenue and Hypera 18%.
The company also disclosed an August 13, 2025 agreement with funds managed by RTW Investments LP for a $75.0 million purchase price tied to FDA approval of Anaphylm and other conditions, with tiered U.S. revenue-share payments capped at $187.5 million by December 31, 2035 or $225.0 million thereafter.
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 (AQST) Chief Operating Officer reported transactions on 10/15/2025. The officer exercised 25,000 non-qualified stock options at a $3.1027 exercise price (code M) and sold 67,575 shares at an average price of $7.01 (code S), pursuant to a Rule 10b5-1 trading plan.
Following the transactions, the officer beneficially owned 240,771 shares directly and 2,000 shares indirectly by spouse. The reported option, granted on June 10, 2021, is fully vested and shows 0 derivative securities remaining after the exercise.
Aquestive Therapeutics (AQST) reported an insider transaction: the Chief Medical Officer sold 20,272 shares of common stock on 10/15/2025 at a weighted average price of $7.00, with individual trades ranging from $7.00 to $7.02, executed under a Rule 10b5-1 trading plan.
After the transaction, the reporting person beneficially owned 282,475 shares, held directly.
Aquestive Therapeutics (AQST) reported an insider transaction on a Form 4. An officer sold 10,000 shares of common stock at $7 on 10/15/2025, reported with transaction code S.
The filing states the sales were effected pursuant to a previously adopted Rule 10b5-1 trading plan. Following the transaction, the reporting person beneficially owns 268,323 shares, held directly. The officer’s title is SVP IT, HR, & Communications.