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.
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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.
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