Aquestive Therapeutics Shares Soar 20% on FDA Approval Pathway

Aquestive Therapeutics, Inc. shares surged 20% in pre-market trading on September 4, 2025, following a significant announcement from the company.

Aquestive Therapeutics announced that the FDA will not require an advisory committee meeting for their new drug application for Anaphylm™. This decision is seen as a positive development, suggesting a smoother approval pathway for the company's novel epinephrine delivery system. The FDA's decision indicates confidence in the safety and efficacy of Anaphylm, which is a sublingual film designed to treat anaphylaxis.

The company's New Drug Application (NDA) remains on track for the FDA's Prescription Drug User Fee Act (PDUFA) goal date of January 31, 2026. This timeline allows Aquestive to continue with commercial planning, ensuring a rapid launch following approval. The absence of an advisory committee meeting is a significant milestone, as it streamlines the regulatory process and reduces potential delays.

Dan Barber, President and CEO of Aquestive Therapeutics, expressed encouragement over the FDA's decision, stating that it reflects the agency's confidence in the data submitted for Anaphylm. This development is expected to bolster investor confidence in the company's prospects, as it moves closer to bringing a potentially life-saving treatment to market.