other material
confidence high
sentiment positive
materiality 0.65
Aquestive provides business update; on track to submit Anaphylm NDA in Q1 2025; cash ~$70M
Aquestive Therapeutics, Inc.
- On track to submit Anaphylm (epinephrine) Sublingual Film NDA to FDA in Q1 2025; potential approval/launch as early as Q1 2026.
- Successfully completed pre-IND meeting for AQST-108 (epinephrine) Topical Gel; Phase 2a in alopecia areata to begin Q2 2025.
- Unaudited cash and cash equivalents approximately $70 million as of Dec 31, 2024.
- Libervant (diazepam) Buccal Film received FDA approval for ages 2-5 and Orphan Drug Exclusivity until April 2031.
- CEO outlines 2025 focus: Anaphylm launch prep, ex-U.S. strategy, AQST-108 Phase 2a, Libervant expansion.