Anaphylm FDA Approval Progress
The FDA confirmed they are aiming for an on-time review with no Advisory Committee meeting required, positioning the company well for a potential Q1 2026 launch.
Successful Financing Rounds
Aquestive completed an $85 million equity raise and a $75 million commercial launch financing, providing capital support through 2027.
Increased Market Awareness and Engagement
Most allergists are aware of Anaphylm, with over 25% completing CME presentations, indicating strong prelaunch engagement.
International Expansion Plans
Positive interaction with Health Canada allows for filing in the first half of 2026, with ongoing discussions with the EMA for European approval.