Aquestive Therapeutics Receives Complete Response Letter from FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 02 2026
0mins
Should l Buy AQST?
Source: Benzinga
- FDA Response Letter: Aquestive Therapeutics received a Complete Response Letter from the FDA regarding the NDA for Anaphylm (dibutepinephrine) sublingual film, highlighting deficiencies in the human factors validation study that could impede the drug's market approval process.
- Human Factors Issues: The FDA identified problems in the human factors validation study for Anaphylm, including difficulties in opening the pouch and incorrect film placement, which, if unaddressed, could pose significant safety risks during anaphylaxis, affecting patient usability.
- Next Steps: To address the FDA's concerns, the company has modified the pouch opening, instructions, and labeling, and plans to rapidly conduct a new human factors validation study while also addressing potential tolerability issues to meet FDA requirements.
- Future Outlook: The company estimates resubmission in early Q3 2026 and plans to submit marketing authorization applications in Europe and New Drug Submissions in Canada in the second half of 2026, with analysts expecting Anaphylm's approval decision in the first half of 2027.
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Analyst Views on AQST
Wall Street analysts forecast AQST stock price to rise
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 4.130
Low
6.00
Averages
9.00
High
12.00
Current: 4.130
Low
6.00
Averages
9.00
High
12.00
About AQST
Aquestive Therapeutics, Inc. is a pharmaceutical company. The Company is engaged in developing orally administered and topical gel products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. It has four commercialized products marketed by the Company’s licensees in the United States and around the world and is the manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary technologies, including PharmFilm, and has proven drug development and commercialization capabilities. The Company 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 dermatology conditions. Its portfolio includes Anaphylm, AQST-108, Libervant, Suboxone, and Emylif.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Notice of Class Action Lawsuit Against Aquestive
- Class Action Notice: Rosen Law Firm reminds investors who purchased Aquestive Therapeutics (NASDAQ:AQST) securities between June 16, 2025, and January 8, 2026, that they must apply to be lead plaintiff by May 4, 2026, to participate in the class action and potentially receive compensation.
- Fee Arrangement: Investors joining the class action will incur no out-of-pocket costs, as the law firm operates on a contingency fee basis, thereby reducing the financial burden on investors and encouraging more victims to participate in the lawsuit.
- Case Background: The lawsuit alleges that Aquestive concealed critical information regarding human factors related to its New Drug Application for its sublingual film, resulting in investor losses when the truth was revealed, highlighting significant deficiencies in the company's disclosure practices.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has achieved multiple large settlements, recovering over $438 million for investors in 2019 alone, demonstrating its expertise and success in the field, which investors should consider when selecting legal counsel.
See More
Class Action Notice for Aquestive Therapeutics Investors
- Class Action Timeline: Rosen Law Firm has notified investors of Aquestive Therapeutics (NASDAQ: AQST) that the lead plaintiff deadline for the class action is May 4, 2026, covering purchases made between June 16, 2025, and January 8, 2026, urging timely action to protect investor rights.
- Transparent Fee Structure: Investors participating in the class action will incur no out-of-pocket costs, as the law firm operates on a contingency fee basis, which alleviates financial burdens and encourages more affected parties to join the lawsuit.
- Lawsuit Background: The lawsuit alleges that Aquestive made false or misleading statements regarding its New Drug Application, failing to disclose critical human factors in the use of its sublingual film, leading to investor losses when the truth emerged, potentially impacting the company's future market performance.
- Law Firm's Credentials: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, highlighting the importance of selecting experienced legal counsel to effectively safeguard investor interests.
See More
Class Action Reminder for Aquestive Therapeutics Investors
- Lawsuit Background: Robbins LLP reminds all investors who purchased or acquired Aquestive Therapeutics (NASDAQ: AQST) securities between June 16, 2025, and January 8, 2026, that a class action has been filed, alleging the company misled investors regarding the approval status of its drug Anaphylm.
- FDA Feedback: According to the complaint, on January 9, 2026, the FDA confirmed that deficiencies in Aquestive's New Drug Application precluded labeling discussions and post-marketing commitments, resulting in a delay of Anaphylm's launch and failure to secure approval by the January 31, 2026 PDUFA date.
- Stock Price Volatility: Following the FDA's notification, Aquestive's stock price plummeted over 37%, from $6.21 per share on January 8, 2026, to $3.91 per share on January 9, 2026, reflecting a pessimistic market sentiment regarding the company's future prospects.
- Shareholder Action: Affected shareholders can submit their papers by May 4, 2026, to apply as lead plaintiffs in the class action, representing other shareholders in the litigation, and they do not need to participate in the case to be eligible for recovery.
See More
AQST Shareholder Alert: Potential Class Action Lawsuit
- Lawsuit Notice Issued: The Gross Law Firm has issued a notice to shareholders who purchased AQST shares between June 16, 2025, and January 8, 2026, encouraging them to contact the firm regarding potential lead plaintiff appointment to partake in any recovery.
- FDA Deficiency Disclosure: On January 9, 2026, Aquestive announced receipt of a letter from the FDA identifying deficiencies in its Anaphylm New Drug Application, which precluded labeling discussions and indicated that the approval process would be delayed, undermining investor confidence in the company's future.
- Stock Price Plummet: Following the FDA notification, AQST's stock price fell dramatically from $6.21 per share on January 8, 2026, to $3.91 per share on January 9, representing a decline of over 37% in a single day, reflecting market pessimism regarding the company's outlook.
- Shareholder Action Deadline: Shareholders must register by May 4, 2026, to participate in the class action lawsuit, with the Gross Law Firm committed to providing registered shareholders with monitoring services to keep them informed about the case's progress.
See More
Class Action Lawsuit Filed Against Aquestive
- Lawsuit Background: Bragar Eagel & Squire, P.C. has initiated a class action lawsuit against Aquestive Therapeutics on behalf of investors who purchased securities between June 16, 2025, and January 8, 2026, reflecting disappointment over the company's failure to secure timely approval for its new drug Anaphylm.
- FDA Deficiency Disclosure: The lawsuit highlights that on January 9, 2026, the FDA confirmed deficiencies in Aquestive's New Drug Application, leading to delays in Anaphylm's launch, which directly impacted investor confidence and stock price.
- Stock Price Plunge: Following the FDA announcement, Aquestive's stock price plummeted over 37%, from $6.21 per share on January 8, 2026, to $3.91, indicating a pessimistic outlook from the market regarding the company's future.
- Investor Action: Investors are urged to apply by May 4, 2026, to be appointed as lead plaintiffs, highlighting concerns over corporate governance and transparency, which may influence future investment decisions.
See More
Aquestive Reaffirms Anaphylm NDA Resubmission Timeline
- FDA Meeting Outcomes: Aquestive's Type A meeting with the FDA confirmed key program elements for the Anaphylm NDA resubmission, expected in Q3 2026, demonstrating the company's strong commitment to addressing the treatment of allergic reactions.
- Study Design Feedback: The FDA provided preliminary comments on the pharmacokinetic (PK) and human factors (HF) study designs, emphasizing consistency with past studies, which enhances the likelihood of future approval by ensuring scientific rigor and effectiveness.
- Packaging Improvements: The company showcased improvements to the Anaphylm product packaging during the meeting, aimed at enhancing ease of opening and reducing film tearing risks, which received FDA acknowledgment and will be tested in the upcoming human factors study.
- International Market Expansion: In addition to the U.S., Aquestive is advancing regulatory submissions for Anaphylm in Canada and the European Union, indicating the company's commitment to bringing this innovative drug to the global market to meet the growing demand for allergy treatments.
See More
Notice of Class Action Lawsuit Against Aquestive
- Class Action Notice: Rosen Law Firm reminds investors who purchased Aquestive Therapeutics (NASDAQ:AQST) securities between June 16, 2025, and January 8, 2026, that they must apply to be lead plaintiff by May 4, 2026, to participate in the class action and potentially receive compensation.
- Fee Arrangement: Investors joining the class action will incur no out-of-pocket costs, as the law firm operates on a contingency fee basis, thereby reducing the financial burden on investors and encouraging more victims to participate in the lawsuit.
- Case Background: The lawsuit alleges that Aquestive concealed critical information regarding human factors related to its New Drug Application for its sublingual film, resulting in investor losses when the truth was revealed, highlighting significant deficiencies in the company's disclosure practices.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has achieved multiple large settlements, recovering over $438 million for investors in 2019 alone, demonstrating its expertise and success in the field, which investors should consider when selecting legal counsel.
See More
Class Action Notice for Aquestive Therapeutics Investors
- Class Action Timeline: Rosen Law Firm has notified investors of Aquestive Therapeutics (NASDAQ: AQST) that the lead plaintiff deadline for the class action is May 4, 2026, covering purchases made between June 16, 2025, and January 8, 2026, urging timely action to protect investor rights.
- Transparent Fee Structure: Investors participating in the class action will incur no out-of-pocket costs, as the law firm operates on a contingency fee basis, which alleviates financial burdens and encourages more affected parties to join the lawsuit.
- Lawsuit Background: The lawsuit alleges that Aquestive made false or misleading statements regarding its New Drug Application, failing to disclose critical human factors in the use of its sublingual film, leading to investor losses when the truth emerged, potentially impacting the company's future market performance.
- Law Firm's Credentials: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, highlighting the importance of selecting experienced legal counsel to effectively safeguard investor interests.
See More
Class Action Reminder for Aquestive Therapeutics Investors
- Lawsuit Background: Robbins LLP reminds all investors who purchased or acquired Aquestive Therapeutics (NASDAQ: AQST) securities between June 16, 2025, and January 8, 2026, that a class action has been filed, alleging the company misled investors regarding the approval status of its drug Anaphylm.
- FDA Feedback: According to the complaint, on January 9, 2026, the FDA confirmed that deficiencies in Aquestive's New Drug Application precluded labeling discussions and post-marketing commitments, resulting in a delay of Anaphylm's launch and failure to secure approval by the January 31, 2026 PDUFA date.
- Stock Price Volatility: Following the FDA's notification, Aquestive's stock price plummeted over 37%, from $6.21 per share on January 8, 2026, to $3.91 per share on January 9, 2026, reflecting a pessimistic market sentiment regarding the company's future prospects.
- Shareholder Action: Affected shareholders can submit their papers by May 4, 2026, to apply as lead plaintiffs in the class action, representing other shareholders in the litigation, and they do not need to participate in the case to be eligible for recovery.
See More
AQST Shareholder Alert: Potential Class Action Lawsuit
- Lawsuit Notice Issued: The Gross Law Firm has issued a notice to shareholders who purchased AQST shares between June 16, 2025, and January 8, 2026, encouraging them to contact the firm regarding potential lead plaintiff appointment to partake in any recovery.
- FDA Deficiency Disclosure: On January 9, 2026, Aquestive announced receipt of a letter from the FDA identifying deficiencies in its Anaphylm New Drug Application, which precluded labeling discussions and indicated that the approval process would be delayed, undermining investor confidence in the company's future.
- Stock Price Plummet: Following the FDA notification, AQST's stock price fell dramatically from $6.21 per share on January 8, 2026, to $3.91 per share on January 9, representing a decline of over 37% in a single day, reflecting market pessimism regarding the company's outlook.
- Shareholder Action Deadline: Shareholders must register by May 4, 2026, to participate in the class action lawsuit, with the Gross Law Firm committed to providing registered shareholders with monitoring services to keep them informed about the case's progress.
See More
Class Action Lawsuit Filed Against Aquestive
- Lawsuit Background: Bragar Eagel & Squire, P.C. has initiated a class action lawsuit against Aquestive Therapeutics on behalf of investors who purchased securities between June 16, 2025, and January 8, 2026, reflecting disappointment over the company's failure to secure timely approval for its new drug Anaphylm.
- FDA Deficiency Disclosure: The lawsuit highlights that on January 9, 2026, the FDA confirmed deficiencies in Aquestive's New Drug Application, leading to delays in Anaphylm's launch, which directly impacted investor confidence and stock price.
- Stock Price Plunge: Following the FDA announcement, Aquestive's stock price plummeted over 37%, from $6.21 per share on January 8, 2026, to $3.91, indicating a pessimistic outlook from the market regarding the company's future.
- Investor Action: Investors are urged to apply by May 4, 2026, to be appointed as lead plaintiffs, highlighting concerns over corporate governance and transparency, which may influence future investment decisions.
See More
Aquestive Reaffirms Anaphylm NDA Resubmission Timeline
- FDA Meeting Outcomes: Aquestive's Type A meeting with the FDA confirmed key program elements for the Anaphylm NDA resubmission, expected in Q3 2026, demonstrating the company's strong commitment to addressing the treatment of allergic reactions.
- Study Design Feedback: The FDA provided preliminary comments on the pharmacokinetic (PK) and human factors (HF) study designs, emphasizing consistency with past studies, which enhances the likelihood of future approval by ensuring scientific rigor and effectiveness.
- Packaging Improvements: The company showcased improvements to the Anaphylm product packaging during the meeting, aimed at enhancing ease of opening and reducing film tearing risks, which received FDA acknowledgment and will be tested in the upcoming human factors study.
- International Market Expansion: In addition to the U.S., Aquestive is advancing regulatory submissions for Anaphylm in Canada and the European Union, indicating the company's commitment to bringing this innovative drug to the global market to meet the growing demand for allergy treatments.
See More
