Aquestive Therapeutics received a Complete Response Letter from the FDA regarding its New Drug Application for Anaphylm, citing deficiencies in the human factors validation study. The agency identified difficulties with pouch opening and film placement that could pose safety risks during anaphylactic events. No chemistry, manufacturing or controls issues were noted, and comparability data including bracketing and repeat-dose studies were deemed sufficient.

Despite the CRL, AQST shares have rallied by nearly 39% in recent trading sessions. The company’s market capitalization stands at approximately 500 million, supported by an average daily trading volume exceeding 60 million shares on the NASDAQ exchange. Over the past year, the stock has oscillated between a low near 2.12 and a high above 7.50, reflecting heightened investor interest around regulatory developments.

To address the FDA’s concerns, Aquestive has redesigned the pouch, updated instructions for use, and enhanced carton labeling. A new human factors validation study and a supportive pharmacokinetics study will be conducted in parallel, with company leadership targeting an NDA resubmission in early Q3 2026. Planning is underway to seek rapid FDA review, while parallel filings are anticipated in Europe and Canada in the second half of 2026.

Analysts remain bullish on AQST’s long-term prospects. New Street Research has set a price target implying roughly 193% upside, and Oppenheimer has maintained an Outperform rating despite the recent setback. Market observers expect an FDA approval decision for Anaphylm in the first half of 2027, underscoring confidence in the drug’s commercial potential if human factors issues are successfully resolved.