Aquestive Therapeutics shares surge 21.39% intraday after FDA waives advisory committee meeting for Anaphylm, a device-free, sublingual epinephrine film for severe allergic reactions.

Aquestive Therapeutics, Inc. surged 21.39% intraday after the FDA announced that the company's Anaphylm new drug application does not require an advisory committee meeting, with the PDUFA target date remaining January 31, 2026. Anaphylm is a device-free, sublingual epinephrine film, and if approved, it will be the first FDA-approved non-invasive treatment for severe allergic reactions. The company recently completed a $160 million financing round to support commercial launch post-approval.