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.
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.