Aquestive Therapeutics Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for Anaphylm™
(NASDAQ:AQST) WARREN, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that an advisory committee meeting is not required for Anaphylm™ (dibutepinephrine) Sublingual Film. The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm remains January 31, 2026.
Related Questions
How does the removal of an FDA advisory committee meeting affect the probability and timing of Anaphylm™ approval and the short‑term price target for AQST?
What is the market currently pricing in for the January 31, 2026 PDUFA action date, and does this update imply a re‑rating of risk/reward for the stock?
How does this regulatory progression compare to peers with similar allergy‑treatment pipelines, and could it give Aquestive a competitive advantage in the market?