FDA identifies deficiencies in Aquestive's Anaphylm NDA, precluding labeling talks

Aquestive Therapeutics, Inc.

FDA letter notes deficiencies in Anaphylm NDA that preclude labeling and post-marketing discussions; review ongoing with PDUFA date Jan 31, 2026.
Company working to understand and resolve deficiencies; delay in potential approval possible if concerns not resolved by PDUFA date.
Unaudited cash and equivalents of ~$120M as of Dec 31, 2025; company believes it is sufficient for U.S. launch and global expansion.
Global strategy advancing: expects to submit in Canada H1 2026, Europe H2 2026, and feedback from UK MHRA in Q1 2026.
Anaphylm supported by 11 clinical studies with ~967 administrations; PK profile comparable to epinephrine auto-injectors.

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