FDA will not require advisory committee for Aquestive's Anaphylm NDA; PDUFA Jan 31, 2026

Aquestive Therapeutics, Inc.

FDA informed Aquestive that no advisory committee meeting is required for Anaphylm (dibutepinephrine) Sublingual Film NDA.
PDUFA target action date remains January 31, 2026; commercial planning underway for rapid post-approval launch.
Anaphylm could be first FDA-approved, non-invasive, orally delivered epinephrine for severe allergic reactions, including anaphylaxis.
Company recently completed $160M in financing activities to support broad healthcare provider and patient outreach upon approval.
NDA includes 11 clinical studies with 967 administrations (single and repeat dose) in adults and children over 30 kg.

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