Aquestive Therapeutics Faces FDA Setback for Anaphylm
Aquestive Therapeutics disclosed FDA deficiencies in its Anaphylm NDA, halting labeling discussions and causing a 37% stock drop. The setback does not represent a final rejection, leaving a path for resubmission.
Aquestive Therapeutics disclosed on January 9, 2026 that the U.S. Food and Drug Administration identified significant deficiencies in its New Drug Application for Anaphylm, an investigational sublingual film for severe allergic reactions including anaphylaxis. The deficiencies halted discussions around labeling and post-marketing requirements, effectively blocking approval ahead of the January 31, 2026 PDUFA action date. The company's stock dropped 37% that day, from $6.21 to $3.91.
The FDA's communication did not constitute a full rejection; it highlighted issues that could potentially be resolved, leaving open the possibility of resubmission after the deficiencies are addressed. The stock continued to slide, reaching $2.95 on January 30, and has since stabilized near $4.04. Aquestive Therapeutics had a market capitalization of approximately $735.52 million and a negative price-to-earnings ratio of -8.81 at the time of the disclosure.
A shareholder class action related to the Anaphylm approval timeline has a lead plaintiff deadline of May 4, 2026. The company retains the option to resubmit its application after correcting the issues identified by the FDA.