FDA Filing for Anaphylm
Aquestive Therapeutics has begun the filing process with the FDA for approval of Anaphylm, an epinephrine sublingual film. The NDA acceptance is expected in June 2025, with a potential launch in Q1 2026.
Pediatric Study Progress for Anaphylm
The pediatric study for Anaphylm has progressed as expected, with data supporting the product label to mirror existing EpiPen auto injector parameters.
International Expansion Plans
Aquestive is preparing to submit applications for Anaphylm in the EU, UK, and Canada, exploring ex-U.S. partnerships for commercialization.
Development of AQST-108
Aquestive plans to open an IND for AQST-108, a topical gel formulation of epinephrine, with a Phase 2a trial expected in the next quarter.
Revenue Growth in 2024
Total revenues increased by 14% to $57.6 million for the full year 2024, driven by increases in license and royalty revenue.