Aquestive completes Anaphylm oral allergen challenge enrollment; unveils AQST-108 Phase 2 for alopecia areata

Aquestive Therapeutics, Inc.

Anaphylm (epinephrine sublingual film) oral allergen challenge study fully enrolled; topline data expected Q4 2024.
Pre-NDA meeting request submitted to FDA; NDA submission planned for Q1 2025, launch by end-2025 or early 2026.
AQST-108 (epinephrine topical gel) first human study completed: no serious adverse events, zero plasma drug levels observed.
AQST-108 to be developed for alopecia areata (6.7M US patients); Phase 2 design outlined for mild-to-moderate disease.
Pre-IND meeting for AQST-108 targeted Q1 2025; Phase 2 initiation expected H2 2025 pending FDA alignment.

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