Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm™
Rhea-AI Summary
Aquestive Therapeutics (NASDAQ: AQST) announced the FDA issued a Complete Response Letter for Anaphylm (dibutepinephrine) on Jan 30, 2026, citing human factors and a supportive PK study requirement.
The company says the CRL is confined to packaging/administration, plans a modified pouch/instructions, a new HF validation and PK study, and estimates resubmission in Q3 2026. No CMC issues were noted. Aquestive expects EU and Canada filings in H2 2026 and says it remains well-capitalized to complete approval and pre-launch activities.
Positive
- CRL limited to human factors and a single PK study
- No CMC issues raised by the FDA in the CRL
- Plans resubmission target of Q3 2026
- EMA feedback: no additional clinical trials required
- Comprehensive program: 11 studies with ~967 administrations
- Company expects sufficient funding to complete approval and pre-launch
Negative
- FDA CRL delays potential U.S. approval and market launch
- Human factors: difficulty opening pouch and incorrect film placement
- Requires new HF validation study and a supportive PK study
- Resubmission timing subject to FDA review durations and study completion
- Company will address potential tolerability issues prior to resubmission
Market Reaction
Following this news, AQST has gained 38.98%, reflecting a significant positive market reaction. Argus tracked a peak move of +41.6% during the session. Argus tracked a trough of -10.8% from its starting point during tracking. Our momentum scanner has triggered 36 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $4.10. This price movement has added approximately $101M to the company's valuation.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.
Key Figures
Market Reality Check
Peers on Argus
AQST fell 6.65% while peers showed mixed, smaller moves (e.g., ESPR -3.42%, AKBA -4.08%, ORGO and EOLS slightly positive), indicating a stock-specific reaction to the FDA Complete Response Letter.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 09 | Regulatory update | Negative | -37.0% | FDA identified NDA deficiencies that could delay potential Anaphylm approval. |
| Nov 24 | Conference participation | Neutral | +1.1% | Planned Piper Sandler fireside chat focused on Anaphylm progress and readiness. |
| Nov 05 | Earnings update | Negative | -1.3% | Q3 2025 loss alongside continued investment and dependency on Anaphylm timeline. |
| Nov 04 | Leadership changes | Positive | -6.3% | New development and medical leadership to support planned Anaphylm launch. |
| Nov 03 | Conference announcement | Neutral | -4.8% | Upcoming Piper Sandler chat highlighting regulatory progress and commercial plans. |
Regulatory setbacks for Anaphylm have previously triggered large negative moves, while corporate and conference updates have produced modest or mixed reactions.
Over the last few months, AQST’s news flow has centered on Anaphylm and corporate positioning. On Jan 9, 2026, the FDA flagged NDA deficiencies ahead of the Jan 31, 2026 PDUFA date, and shares dropped 37.04%. Earlier, Q3 2025 earnings on Nov 5 detailed revenue of $12.8M and ongoing losses tied to R&D and commercialization. Leadership additions on Nov 4, 2025 and multiple Piper Sandler events focused on Anaphylm’s regulatory path and launch readiness. Today’s Complete Response Letter continues this regulatory narrative and follows prior deficiency disclosures.
Market Pulse Summary
The stock is surging +39.0% following this news. A strong positive reaction would have contrasted with the prior pattern where regulatory uncertainty around Anaphylm led to sharp pullbacks, such as the 37.04% decline after the Jan 9, 2026 deficiency update. Any sustained strength would likely have reflected investor confidence in management’s plan to resolve human‑factors and PK issues and leverage the existing 11‑study clinical package. However, the stock’s position well below its 52-week high could still leave it sensitive to future regulatory news.
Key Terms
complete response letter regulatory
new drug application regulatory
sublingual film medical
anaphylaxis medical
human factors technical
pharmacokinetics medical
type a meeting regulatory
marketing authorization application regulatory
AI-generated analysis. Not financial advice.
- Deficiencies limited to packaging and administration
- Company believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 2026
- Remains well-capitalized and anticipates ending 2026 with significant cash
- Reiterates plans to submit in Canada and EU by the end of 2026
- Company to host investor call on February 2, 2026, at 8:00am ET
WARREN, N.J., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 30, 2026 for the New Drug Application (NDA) seeking approval of Anaphylm™ (dibutepinephrine) Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more (approximately 66 pounds).
“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. We are encouraged that the issues in the letter are limited to human factors and a supportive PK study, once human factors are addressed, and we noted several labeling comments that will inform the final label for Anaphylm, if approved by the FDA,” said Daniel Barber, President and CEO of Aquestive. “We remain confident in the effectiveness and safety of Anaphylm and its potential as an easy-to-use, easy-to-carry, fast-acting epinephrine treatment. We look forward to working with the FDA to achieve approval for Anaphylm. Our commitment to bringing this innovative therapy to the allergy community remains steadfast.”
In the CRL, which focuses on administration and labeling guidance, the FDA cited deficiencies in the Anaphylm human factors (HF) validation study. These included instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis. To resolve the FDA’s concerns, the Company has modified the pouch opening, instructions for use, pouch and carton labeling, and plans to rapidly conduct a new HF validation study with these modifications. The Company also plans to further address potential tolerability issues in its resubmission. Comparability data submitted as part of the Anaphylm NDA, such as bracketing, repeat dose, and sustainability, were not questioned in the CRL. There were also no CMC issues noted in the CRL.
Due to the requirements related to HF, clinical pharmacology requested a single pharmacokinetics (PK) study to understand the impact of any modifications to packaging and labeling. The Agency indicated that the HF and PK studies can be conducted in parallel. No additional studies were requested in the CRL.
The Company plans to closely work with the Agency to achieve approval for Anaphylm as expeditiously as possible. As an initial step, the Company will request a Type A meeting with the FDA to discuss the most efficient path forward for resubmission. Based on its initial review of the CRL, the Company estimates resubmission in Q3 2026, assuming completion of the HF and PK studies and typical response times from the FDA. The Company plans to request rapid review by the FDA.
Allergist Jay Lieberman, M.D., Professor at the University of Tennessee Health Science Center and a practicing physician at LeBonheur Children’s Hospital, said, “As a clinician and investigator for various allergy clinical trials, I am well versed in the nuances related to clinical development and regulatory approval. FDA’s response is focused on patient experience issues and their potential impacts. I am confident in Aquestive’s ability to address the issues described above and remain optimistic in having Anaphylm available for my patients in the future. Given the continued underuse of epinephrine in anaphylaxis, the availability of more treatment options remains a top priority for clinicians and the allergy community.”
Aquestive also plans to continue advancing its global expansion strategy for Anaphylm, having initiated regulatory engagements in Canada, Europe, and the United Kingdom in 2025. The Company received positive feedback from the European Medicines Agency (EMA) that no further clinical trials are needed prior to regulatory approval submission. Aquestive expects to submit its marketing authorization application in Europe as well as its New Drug Submission (NDS) in Canada in the second half of 2026. The Company also expects to receive feedback from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom in the first quarter of 2026. These markets represent important opportunities to expand access to the Company's non-invasive epinephrine therapy globally.
The Company believes that the original Anaphylm NDA submission is supported by a comprehensive clinical development program consisting of eleven independent clinical studies with approximately 967 total administrations across 411 subjects, including 840 single-dose and 127 repeat-dose exposures of Anaphylm. As part of the clinical development program, Aquestive conducted a first-of-its-kind oral allergy syndrome (OAS) study, which demonstrated Anaphylm's performance in a real-world, allergen-induced setting. The program demonstrated that Anaphylm delivers a PK profile comparable to the leading epinephrine auto-injectors. These studies showed that Anaphylm was generally well-tolerated and had a safety profile similar to that of epinephrine.
With 20 years since its founding, 6 FDA approvals, and more than 2.5 billion doses of oral film products shipped to patients worldwide, Aquestive continues to believe in Anaphylm’s ease-of-use profile and potential to be the first and only non-invasive, orally delivered epinephrine for the treatment of severe life-threatening allergic reactions, including anaphylaxis, if approved by the FDA.
The Company believes that it has sufficient funding to complete the Anaphylm approval and pre-launch processes in the U.S., while progressing Anaphylm in other key markets outside the U.S.
Conference Call and Webcast
The Company will host a conference call at 8:00 a.m. ET on Monday, February 2, 2026.
In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin.
A live webcast of the call will be available on Aquestive’s website here.
Further details regarding the FDA’s comments are available in a supplemental presentation located in the Events and Presentation section of the Investor page on the Aquestive website.
About Anaphylm™ (dibutepinephrine) Sublingual Film
Anaphylm is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The primary packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.
About Aquestive Therapeutics
Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has four licensed commercialized products marketed by its licensees in the U.S. and around the world and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel product candidate for various possible dermatological conditions, including alopecia areata. For more information, visit Aquestive.com and follow us on LinkedIn.
Forward-Looking Statement
Certain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm™ (dibutepinephrine) Sublingual Film through clinical development and approval by the FDA, including whether our clinical and other data will be adequate enough to address the concerns raised by the FDA in the Complete Response Letter dated January 30, 2026 (CRL) provided to the Company and for the FDA to finally approve Anaphylm or whether the FDA may request further information from us, disagree with our findings or otherwise undertake a lengthy review of our resubmission, and challenges regarding the following commercial launch of Anaphylm, if approved by the FDA; the advancement and related timing of potential international regulatory filings and marketing authorization of Anaphylm outside of the U.S.; that Anaphylm will be the first and only oral administration of epinephrine and accepted as an alternative to existing standards of care, if Anaphylm is approved by the FDA; the potential benefits Anaphylm could bring to patients, if approved by the FDA; the advancement and related timing of our product candidate AQST-108 (epinephrine) Topical Gel through clinical development and FDA regulatory approval process, including design and timing of clinical studies including those necessary to support the targeted indication of alopecia areata for AQST-108; our future financial and operating results and financial position, including with respect to our 2025 financial outlook, estimated cash runway and sufficiency to support the Company’s long-term growth strategy for the potential regulatory approval and subsequent launch of Anaphylm in the U.S. and around the world, if approved by the respective regulatory authorities in such jurisdictions; and business strategies, market opportunities, and other statements that are not historical facts.
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans for Anaphylm; risk of delays in advancement of the regulatory approval process through the FDA of our product candidate Anaphylm, or failure to receive FDA approval at all; risk of FDA inspections of manufacturing and clinical study sites for any of our product candidates, including Anaphylm; risk of government shutdowns or actions to reduce government workforces on the ability of the FDA to act on the approval of our product candidates, including Anaphylm; risk of the Company’s ability to generate sufficient clinical and other human factor data, including with respect to our submission of pharmacokinetic and pharmacodynamic (PK/PD) comparability data for FDA approval of Anaphylm; risks associated with our ability to address the FDA’s comments on and identified deficiencies in our NDA, including the concerns raised by the FDA in the Complete Response Letter dated January 30, 2026 issued to the Company for approval of Anaphylm; risks that the FDA may consider issues raised in the citizen petition submitted to the FDA regarding Anaphylm on October 1, 2025; risks associated with the success of any competing products, including generics; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of development of a sales and marketing capability for commercialization of our product candidates, including Anaphylm, if approved by the FDA; risks associated with the potential impact on the value of the Company of the sale or outlicensing of our product and product candidates, including Anaphylm; risk of sufficient capital and cash resources, including sufficient access to available debt and equity financing, including under our ATM facility, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements to support our growth strategy, and other cash needs, at the times and in the amounts needed, including to commence principal payments on our
PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.
Investor Contact:
Brian Korb
astr partners
brian.korb@astrpartners.com
FAQ
What did Aquestive (AQST) say about the FDA Complete Response Letter on Feb 2, 2026?
When does Aquestive expect to resubmit the Anaphylm NDA (AQST)?
Does the FDA CRL question Anaphylm’s chemistry, manufacturing, or safety for AQST?
How will the FDA’s human factors findings affect Anaphylm’s approval path for AQST?
What is Aquestive’s timeline for international regulatory submissions for Anaphylm (AQST)?
Will the CRL materially affect Aquestive’s funding needs or 2026 cash outlook (AQST)?
