Aquestive receives FDA CRL for Anaphylm; deficiencies limited to packaging, administration

Aquestive Therapeutics, Inc.

FDA CRL Jan 30, 2026 for Anaphylm NDA; deficiencies in human factors validation study and request for PK study.
Company plans Type A meeting, new HF and PK studies; expects resubmission in Q3 2026.
Global: positive EMA feedback no further trials needed; submit in Europe and Canada H2 2026; UK feedback Q1 2026.
CEO: issues limited to packaging/administration; company well-capitalized to complete approval and pre-launch.

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