Packaging Hurdle for Aquestive's Anaphylm: A Setback or a Manageable Delay for Its Allergy Ambitions?
Aquestive Therapeutics faces a regulatory delay for its sublingual epinephrine film, Anaphylm, after the FDA raised concerns primarily about its packaging and labeling. The company views the issues as solvable and is moving forward with redesigns and new studies, aiming for a 2026 resubmission while advancing parallel filings abroad.