Aquestive positive OAS study: Anaphylm resolves symptoms in 12 min median, meets endpoints

Aquestive Therapeutics, Inc.

OAS challenge study met primary and secondary endpoints; no significant PK difference with vs. without allergen.
Median time to complete symptom resolution: 12 minutes (vs. 74 minutes at screening); symptoms began resolving as early as 2 min.
All instances of symptomatic swelling resolved within 5 minutes after Anaphylm administration.
Pre-NDA meeting with FDA requested in Q4 2024; NDA submission planned Q1 2025; potential launch Q1 2026 if approved.
Anaphylm is a non-invasive oral epinephrine film for severe allergic reactions; adverse events mild/moderate and resolved.

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