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Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that Health Canada has granted the Company a meeting to discuss Aquestive's planned New Drug Submission (NDS) for Anaphylm™ (epinephrine) Sublingual Film in Canada. In addition, the Company has submitted an initial briefing book to the European Medicines Agency (EMA). The Company plans to submit a Marketing Authorization Application (MAA) to the EMA as soon as possible.
"These regulatory activities mark the pivotal first steps in Aquestive's comprehensive ex-U.S. regulatory strategy," said Dan Barber, President and Chief Executive Officer of Aquestive. "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. Our proven ability to successfully bring innovative therapies to market globally, combined with our oral epinephrine approach, positions us to fundamentally change how patients and caregivers manage severe allergic reactions, including anaphylaxis."
Aquestive brings significant regulatory and commercialization experience to this expansion effort, with six FDA-approved drugs in its portfolio and products currently available across six continents. This established global footprint and regulatory track record positions the Company to efficiently navigate international approval processes.
Unlike traditional epinephrine auto-injectors that require needles, Anaphylm™ is administered orally, addressing critical barriers to treatment, including needle phobia, device malfunction concerns, and portability challenges that affect patient compliance and emergency response.
The Company's ex-U.S. regulatory strategy prioritizes markets with significant unmet medical needs and regulatory frameworks conducive to innovative therapies. EMA and Canada represent ideal initial international markets given their collaborative regulatory environment and substantial population of patients requiring reliable anaphylaxis treatment options.
Aquestive will continue to provide updates on its global regulatory approval progress as it works to establish Anaphylm as the new standard of care for the treatment of severe allergic reactions and anaphylaxis worldwide.
Posted In: AQST
