TLDR
- AQST rockets 44% as market shrugs off FDA delay on Anaphylm approval
- AQST spikes after FDA setback as company maps fast recovery plan
- AQST surges despite CRL as traders focus on limited FDA concerns
- AQST rallies sharply while company pushes toward 2026 resubmission
- AQST jumps on confidence in approval path after FDA letter
Aquestive Therapeutics (AQST) surged to $4.27 after a rapid breakout and held strong gains into midday trading. Aquestive Therapeutics, Inc. climbed about 44% despite fresh regulatory pressure from the FDA. The move placed AQST at the center of market focus while the company addressed a major approval delay.
Aquestive Therapeutics, Inc., AQST
FDA response reshapes near-term approval timeline
AQST reported that the FDA issued a Complete Response Letter for its Anaphylm drug application. The agency limited its concerns to human factors validation and supportive pharmacokinetics work. The letter did not raise chemistry or manufacturing objections, and that narrowed the scope of required fixes.
The company immediately revised packaging design and instructions to address administration issues. It prepared a new validation study to test the modified pouch and labeling. The FDA allowed parallel execution of the validation and pharmacokinetics studies, which shortened the projected timeline.
Management now targets a resubmission window in the third quarter of 2026. The company plans to request rapid review after completing required studies. AQST reacted sharply in the market as traders focused on the limited nature of regulatory concerns.
Company advances corrective strategy and funding plan
Aquestive stated that it retains enough funding to complete approval and pre-launch activities. It emphasized that earlier clinical data remained intact and unchallenged by regulators. That stability supported confidence in the core development program behind Anaphylm.
The company already conducted eleven clinical studies involving hundreds of administrations. Results showed comparable pharmacokinetic performance to leading epinephrine auto-injectors. Safety outcomes aligned with known epinephrine profiles and demonstrated consistent tolerability.
Executives continued to position Anaphylm as a non-invasive treatment alternative. They stressed ease of use and portability as central advantages over current devices. AQST maintained momentum as the company communicated a defined regulatory recovery path.
Global expansion plans continue alongside U.S. process
Aquestive also advanced regulatory engagement outside the United States during the review period. It reported positive feedback from European authorities regarding clinical data sufficiency. As a result, the company expects to file marketing applications in Europe and Canada in 2026.
Regulators in the United Kingdom continue to evaluate the therapy under ongoing discussions. Meanwhile, international submissions form a parallel strategy that diversifies approval risk. The company framed these regions as critical to global adoption of its film-based delivery platform.
Global outreach strengthens the commercial outlook even as U.S. approval remains pending. Additionally, expansion efforts reinforce the company’s long-term positioning in allergy treatment. AQST reflected this broader strategy as the stock absorbed the FDA setback.
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