Aquestive gears up for Q3 resubmission after FDA CRL on Anaphylm
Aquestive Therapeutics received an FDA Complete Response Letter for Anaphylm Sublingual Film, with deficiencies limited to human factors and a required PK study; no CMC or broad safety issues were raised. The company plans to revise packaging/instructions, conduct a new HF validation and a PK study in parallel, and target resubmission in Q3 2026. Global filings in Europe and Canada are expected in 2026 as well, and the company remains well-capitalized to support approval and pre-launch activities.