Aquestive Therapeutics Receives Complete Response Letter from FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5d ago
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 over the next 12 months. According to Wall Street analysts, the average 1-year price target for AQST is 8.40 USD with a low forecast of 8.00 USD and a high forecast of 10.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 3.840
Low
8.00
Averages
8.40
High
10.00
Current: 3.840
Low
8.00
Averages
8.40
High
10.00
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.
Faruqi & Faruqi Investigates Aquestive Therapeutics After FDA Concerns
- Stock Price Plunge: Shares of Aquestive Therapeutics fell approximately 40% intraday on Friday after the FDA identified deficiencies in its New Drug Application, significantly undermining investor confidence and potentially leading to greater financial strain on the company.
- FDA Deficiency Warning: The FDA indicated that unidentified deficiencies currently hinder discussions regarding labeling and post-marketing requirements, which not only jeopardizes the approval prospects for Anaphylm but may also delay its market launch, further impacting the company's revenue expectations.
- Legal Consultation Opportunity: Faruq & Faruqi LLP is investigating potential claims against Aquestive Therapeutics, encouraging investors who suffered significant losses to reach out, indicating that the company may face legal liabilities and increasing the legal risks for investors.
- Investor Rights Protection: The law firm has recovered hundreds of millions of dollars for investors since its founding in 1995, demonstrating its expertise in securities law, which may provide legal support for affected investors seeking compensation.
See More
Faruqi & Faruqi Investigates Aquestive Therapeutics' FDA Issues
- Stock Price Plunge: Shares of Aquestive Therapeutics fell approximately 40% intraday on Friday after the FDA identified deficiencies in its New Drug Application, significantly undermining investor confidence and potentially leading to further financial losses.
- FDA Deficiency Warning: The FDA indicated that unidentified deficiencies currently hinder discussions on labeling and post-marketing requirements, which not only affects the approval prospects for Anaphylm but also introduces uncertainty regarding the company's future revenue streams.
- Legal Consultation Opportunity: Faruqi & Faruqi LLP is investigating potential claims against Aquestive Therapeutics and encourages investors who suffered significant losses to contact them directly to explore their legal rights, potentially providing a remedy for affected investors.
- Investor Confidence Erosion: The FDA's warning and the sharp decline in stock price have significantly diminished market confidence in Aquestive, likely prompting more investors to seek legal assistance, which could impact the company's shareholder structure and future financing capabilities.
See More
Pomerantz LLP Investigates Fraud Claims Against Aquestive Therapeutics
- Securities Fraud Investigation: Pomerantz LLP is investigating claims on behalf of investors in Aquestive Therapeutics, Inc., focusing on whether the company and its executives engaged in securities fraud or other unlawful business practices, which could lead to significant investor losses.
- FDA Notification of Deficiencies: On January 9, 2026, the CEO of Aquestive announced that the FDA identified deficiencies in the NDA for Anaphylm, preventing discussions on labeling and post-marketing commitments, indicating serious regulatory compliance challenges for the company.
- Stock Price Plunge: Following this announcement, Aquestive's stock price fell by $2.30, or 37.04%, closing at $3.91 per share on January 9, 2026, reflecting market pessimism regarding the company's future prospects.
- Law Firm Background: Pomerantz LLP is a renowned firm in corporate and securities class litigation, established over 85 years ago, dedicated to fighting for the rights of victims of securities fraud, showcasing its expertise and experience in handling such cases.
See More
Aquestive Therapeutics Shares Surge 39% Despite FDA Complete Response Letter
- FDA Response Impact: Despite receiving a Complete Response Letter from the US FDA regarding its Anaphylm (dibutepinephrine) sublingual film application, Aquestive Therapeutics (AQST) shares surged approximately 39% on Monday, reflecting market optimism that the additional information requested by the FDA is less burdensome than anticipated.
- Clarified Concerns: The FDA's concerns are primarily focused on packaging and administration, requiring human factors validation and pharmacokinetics studies to evaluate changes in packaging and labeling, indicating that the company still has room for compliance improvements.
- Rapid Response Plan: The company has already modified the pouch opening, instructions for use, and labeling, and plans to quickly initiate a new validation study to meet FDA requirements, thereby accelerating the resubmission process for Anaphylm.
- Positive Future Outlook: Aquestive indicated that it expects to resubmit the Anaphylm application as early as Q3, demonstrating confidence in the product's market potential while providing a positive revenue guidance outlook for future growth.
See More
Aquestive Therapeutics Receives Complete Response Letter from FDA
- 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.
See More
Schall Law Firm Investigates Aquestive for Securities Violations
- Investigation Launched: The Schall Law Firm has announced an investigation into Aquestive Therapeutics, Inc. regarding potential violations of securities laws, particularly focusing on whether the company issued false or misleading statements that could affect investor rights.
- FDA Notification of Deficiencies: On January 9, 2026, Aquestive disclosed that the FDA identified deficiencies in its NDA for Anaphylm, preventing discussions on labeling and post-marketing commitments, without specifying the deficiencies, which increases uncertainty for investors.
- Stock Price Plummet: Following this news, Aquestive's shares fell by over 37% on the same day, reflecting strong market concerns about the company's future prospects and potentially diminishing investor confidence.
- Investor Rights Protection: The Schall Law Firm encourages affected investors to reach out for free discussions about their rights, demonstrating a commitment to protecting investor interests and potentially leading to further legal actions.
See More
Faruqi & Faruqi Investigates Aquestive Therapeutics After FDA Concerns
- Stock Price Plunge: Shares of Aquestive Therapeutics fell approximately 40% intraday on Friday after the FDA identified deficiencies in its New Drug Application, significantly undermining investor confidence and potentially leading to greater financial strain on the company.
- FDA Deficiency Warning: The FDA indicated that unidentified deficiencies currently hinder discussions regarding labeling and post-marketing requirements, which not only jeopardizes the approval prospects for Anaphylm but may also delay its market launch, further impacting the company's revenue expectations.
- Legal Consultation Opportunity: Faruq & Faruqi LLP is investigating potential claims against Aquestive Therapeutics, encouraging investors who suffered significant losses to reach out, indicating that the company may face legal liabilities and increasing the legal risks for investors.
- Investor Rights Protection: The law firm has recovered hundreds of millions of dollars for investors since its founding in 1995, demonstrating its expertise in securities law, which may provide legal support for affected investors seeking compensation.
See More
Faruqi & Faruqi Investigates Aquestive Therapeutics' FDA Issues
- Stock Price Plunge: Shares of Aquestive Therapeutics fell approximately 40% intraday on Friday after the FDA identified deficiencies in its New Drug Application, significantly undermining investor confidence and potentially leading to further financial losses.
- FDA Deficiency Warning: The FDA indicated that unidentified deficiencies currently hinder discussions on labeling and post-marketing requirements, which not only affects the approval prospects for Anaphylm but also introduces uncertainty regarding the company's future revenue streams.
- Legal Consultation Opportunity: Faruqi & Faruqi LLP is investigating potential claims against Aquestive Therapeutics and encourages investors who suffered significant losses to contact them directly to explore their legal rights, potentially providing a remedy for affected investors.
- Investor Confidence Erosion: The FDA's warning and the sharp decline in stock price have significantly diminished market confidence in Aquestive, likely prompting more investors to seek legal assistance, which could impact the company's shareholder structure and future financing capabilities.
See More
Pomerantz LLP Investigates Fraud Claims Against Aquestive Therapeutics
- Securities Fraud Investigation: Pomerantz LLP is investigating claims on behalf of investors in Aquestive Therapeutics, Inc., focusing on whether the company and its executives engaged in securities fraud or other unlawful business practices, which could lead to significant investor losses.
- FDA Notification of Deficiencies: On January 9, 2026, the CEO of Aquestive announced that the FDA identified deficiencies in the NDA for Anaphylm, preventing discussions on labeling and post-marketing commitments, indicating serious regulatory compliance challenges for the company.
- Stock Price Plunge: Following this announcement, Aquestive's stock price fell by $2.30, or 37.04%, closing at $3.91 per share on January 9, 2026, reflecting market pessimism regarding the company's future prospects.
- Law Firm Background: Pomerantz LLP is a renowned firm in corporate and securities class litigation, established over 85 years ago, dedicated to fighting for the rights of victims of securities fraud, showcasing its expertise and experience in handling such cases.
See More
Aquestive Therapeutics Shares Surge 39% Despite FDA Complete Response Letter
- FDA Response Impact: Despite receiving a Complete Response Letter from the US FDA regarding its Anaphylm (dibutepinephrine) sublingual film application, Aquestive Therapeutics (AQST) shares surged approximately 39% on Monday, reflecting market optimism that the additional information requested by the FDA is less burdensome than anticipated.
- Clarified Concerns: The FDA's concerns are primarily focused on packaging and administration, requiring human factors validation and pharmacokinetics studies to evaluate changes in packaging and labeling, indicating that the company still has room for compliance improvements.
- Rapid Response Plan: The company has already modified the pouch opening, instructions for use, and labeling, and plans to quickly initiate a new validation study to meet FDA requirements, thereby accelerating the resubmission process for Anaphylm.
- Positive Future Outlook: Aquestive indicated that it expects to resubmit the Anaphylm application as early as Q3, demonstrating confidence in the product's market potential while providing a positive revenue guidance outlook for future growth.
See More
Aquestive Therapeutics Receives Complete Response Letter from FDA
- 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.
See More
Schall Law Firm Investigates Aquestive for Securities Violations
- Investigation Launched: The Schall Law Firm has announced an investigation into Aquestive Therapeutics, Inc. regarding potential violations of securities laws, particularly focusing on whether the company issued false or misleading statements that could affect investor rights.
- FDA Notification of Deficiencies: On January 9, 2026, Aquestive disclosed that the FDA identified deficiencies in its NDA for Anaphylm, preventing discussions on labeling and post-marketing commitments, without specifying the deficiencies, which increases uncertainty for investors.
- Stock Price Plummet: Following this news, Aquestive's shares fell by over 37% on the same day, reflecting strong market concerns about the company's future prospects and potentially diminishing investor confidence.
- Investor Rights Protection: The Schall Law Firm encourages affected investors to reach out for free discussions about their rights, demonstrating a commitment to protecting investor interests and potentially leading to further legal actions.
See More
