Aquestive(AQST) - 2025 Q1 - Quarterly Results

Exhibit 99.1 Anaphylm™ (epinephrine) Sublingual Film Aquestive has completed the submission of its New Drug Application (NDA) for Anaphylm with the U.S. Food and Drug Administration (FDA). The NDA includes data from the full adult clinical program and the recently completed pediatric study. Topline results from the pediatric trial in patients aged 7 to 17 demonstrated a pharmacokinetic (PK) profile consistent with prior adult clinical data, supporting a proposed label aligned with the 0.3 mg epinephrine aut ...