FDA Review and Launch Preparation for Anaphylm
The company is on track with the FDA review process for Anaphylm, including pre-commercial launch activities and securing launch financing. The FDA action date is set for January 31, 2026.
Market Opportunity for Anaphylm
The rescue market for severe allergic reactions is expected to grow significantly. Surveys indicate a potential market shift from injectable to non-injectable products, with a market size of up to $2 billion annually.
International Expansion Plans
Meetings with regulatory bodies in Canada and the EU are secured, with plans to complete these meetings by the end of the year and begin filing preparations.
Base Business Growth
The base business showed year-over-year growth in Q2 2025, driven by strong international product performance.
Cash Position and Financial Stability
Aquestive ended the last quarter with $60 million in cash, providing sufficient initial launch funding for Anaphylm.