Aquestive announces FDA to not require advisory committee meeting for Anaphylm

Aquestive Therapeutics (AQST) announced that the U.S. Food and Drug Administration, FDA, has informed the Company that an advisory committee meeting is not required for Anaphylm Sublingual Film. The Prescription Drug User Fee Act, PDUFA, target action date for Anaphylm remains January 31, 2026. “We are encouraged that the FDA has determined that an advisory committee meeting is not required for approval of Anaphylm,” said Dan Barber, President and CEO of Aquestive Therapeutics. “Our device-free, sublingual epinephrine film, is designed to offer patients and caregivers an alternative to traditional auto-injectors and other emerging non-invasive options. If approved by the FDA, we believe Anaphylm would mark a meaningful advancement in anaphylaxis treatment. We are well-positioned for launch and, based on our recent $160 million in financing activities, we will have the ability to ensure broad outreach to healthcare providers, caregivers, and patients following FDA approval.”