Aquestive obtains Health Canada meeting for Anaphylm NDS; EMA briefing book submitted

Aquestive Therapeutics, Inc.

Health Canada grants Q3 2025 meeting for planned New Drug Submission of Anaphylm (epinephrine) Sublingual Film.
Initial briefing book submitted to European Medicines Agency; MA submission planned as soon as possible.
U.S. NDA accepted with PDUFA target action date of January 31, 2026.
Company pursuing parallel ex-U.S. regulatory pathways for needle-free, device-free anaphylaxis treatment.

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