Aquestive Therapeutics Updates Anaphylm Regulatory Status Following FDA Letter While Advancing International Approval Efforts
Benzinga Newsdesk 9 months ago
News
Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time Receives confirmation from FDA that Agency's review of Anaphylm NDA application is
- Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time
- Receives confirmation from FDA that Agency's review of Anaphylm NDA application is ongoing and no final FDA decision has been made
- Progresses global regulatory expansion activities in Canada, Europe, and the United Kingdom for Anaphylm
- Unaudited cash and cash equivalents of approximately $120 million as of December 31, 2025