07:31 AM EDT, 07/15/2025 (MT Newswires) -- Aquestive Therapeutics ( AQST ) said Tuesday that Health Canada has granted a meeting with the company in Q3 to discuss the latter's planned new drug submission for Anaphylm sublingual film, an orally injected emergency treatment for serious allergic reactions, including anaphylaxis.

The company said it has also submitted an initial briefing book to the European Medicines Agency and plans to submit a marketing authorization application to EMA as soon as possible.

"With our U.S. FDA New Drug Application recently accepted and a PDUFA target action date of January 31, 2026, established, we're now positioned to pursue parallel regulatory pathways with the potential to bring needle-free, device-free Anaphylm to patients underserved by current treatment options," said Aquestive Chief Executive Dan Barber.