Aquestive shares jump despite FDA setback for Anaphylm
February 2, 2026 9:47 AM
IH Market News
Aquestive Therapeutics (NASDAQ:AQST) shares surged 18% on Monday even after the company disclosed that it had received a complete response letter (CRL) from the U.S. Food and Drug Administration for Anaphylm, its sublingual film treatment for Type I allergic reactions, including anaphylaxis.
The FDA’s feedback focused narrowly on packaging and administration-related concerns, particularly shortcomings identified in the human factors validation study. The agency cited issues such as difficulty opening the pouch and incorrect placement of the film, which could pose safety risks during an anaphylactic event. In addition, the FDA requested a pharmacokinetics study to assess the impact of any changes to the product’s packaging and labeling.
Aquestive said it is confident the issues can be addressed quickly through updates to the pouch design, instructions for use and labeling. The company plans to carry out a new human factors validation study incorporating these changes and expects to resubmit its application as early as the third quarter of 2026.
“While it is unfortunate to have received a CRL, we believe that, with the clarity we now have from the FDA, we have made significant progress toward approval,” said Daniel Barber, President and CEO of Aquestive. “We are encouraged that the issues in the letter are limited to human factors and a supportive PK study, once human factors are addressed.”
The company stressed that the FDA did not raise any concerns about the comparability data included in the Anaphylm new drug application, such as bracketing, repeat-dose or sustainability data. The CRL also did not flag any issues related to chemistry, manufacturing or controls.
Looking ahead, Aquestive said it remains well capitalized and expects to end 2026 with a strong cash position. The company also reaffirmed plans to file regulatory submissions in Canada and Europe by the end of 2026, noting that the European Medicines Agency has indicated that no additional clinical trials will be required ahead of submission.
Aquestive Therapeutics stock price
Original: Aquestive shares jump despite FDA setback for Anaphylm
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