Aquestive Advances Anaphylm Drug Approval Process Following FDA Feedback
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 02 2026
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Should l Buy AQST?
Source: Newsfilter
- FDA Feedback and Response: Aquestive received a Complete Response Letter from the FDA on January 30, 2026, highlighting deficiencies in packaging and human factors validation for Anaphylm; however, the company believes these issues can be resolved quickly, with plans to resubmit by Q3 2026, thereby maintaining confidence in the drug's approval prospects.
- Strong Financial Position and Market Expansion: The company anticipates ending 2026 with significant cash reserves to support the approval and pre-launch processes for Anaphylm in the U.S. and other markets, while also planning to submit marketing authorization applications in Canada and Europe in the second half of 2026, further expanding its global reach.
- Clinical Research Support: The original NDA submission for Anaphylm is backed by eleven independent clinical studies involving 967 administrations, demonstrating a pharmacokinetic profile comparable to existing epinephrine auto-injectors, indicating its potential as the first non-invasive oral epinephrine treatment for severe allergic reactions if approved.
- Investor Call Scheduled: The company will host an investor call on February 2, 2026, at 8:00 AM ET to discuss FDA feedback and future approval plans, reflecting its commitment to transparent communication and investor relations aimed at bolstering market confidence.
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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: 3.750
Low
6.00
Averages
9.00
High
12.00
Current: 3.750
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.
Faruqi & Faruqi Investigates Aquestive Therapeutics After 40% Stock Plunge
- Stock Plunge: Shares of Aquestive Therapeutics fell approximately 40% intraday on Friday after the FDA identified deficiencies in its New Drug Application for Anaphylm, raising concerns about the drug's approval prospects.
- FDA Feedback: The FDA indicated that unidentified deficiencies currently hinder discussions on labeling and post-marketing requirements, which not only affects the drug's market outlook but also raises doubts about its approvability ahead of the January 31, 2026 PDUFA action date.
- Legal Consultation Opportunity: Faruqi & Faruqi is investigating potential claims against Aquestive Therapeutics and encourages investors who suffered significant losses to contact partner Josh Wilson directly for legal support to protect their rights.
- Investor Protection: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions of dollars for investors, demonstrating its strong capabilities in securities law and commitment to safeguarding investor interests.
See More
Faruqi & Faruqi Investigates Investor Losses in Aquestive Therapeutics
- Legal Investigation Launched: Faruq & Faruqi LLP is investigating potential claims against Aquestive Therapeutics, aiming to provide legal support for investors who have suffered significant losses, highlighting the legal risks the company may face.
- Investor Rights Advocacy: The firm encourages all investors who have incurred losses in Aquestive stock or options to contact partner Josh Wilson directly, demonstrating its commitment to protecting investor rights.
- Historical Performance Review: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions of dollars for investors, showcasing its strong capabilities and extensive experience in securities law, which enhances investor trust in its services.
- Contact Information Provided: Faruqi & Faruqi has made direct contact numbers available, ensuring investors can easily access legal consultation, reflecting its commitment to client service.
See More
Pomerantz LLP Investigates Securities Fraud Claims Against Aquestive Therapeutics
- Securities Fraud Investigation: Pomerantz LLP is investigating claims on behalf of investors of Aquestive Therapeutics, focusing on whether the company and its executives engaged in securities fraud or other unlawful business practices, highlighting concerns for investor rights.
- 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 regulatory compliance challenges for the company.
- Significant Stock Price Drop: Following the FDA notification, Aquestive's stock price fell by $2.30, a decline of 37.04%, closing at $3.91 per share, reflecting market concerns regarding the company's future prospects.
- Law Firm's Reputation: Pomerantz LLP, recognized as a premier firm in securities class litigation for over 85 years, focuses on fighting for the rights of victims of securities fraud and corporate misconduct, underscoring the firm's expertise and influence in the legal field.
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
Faruqi & Faruqi Investigates Aquestive Therapeutics After 40% Stock Plunge
- Stock Plunge: Shares of Aquestive Therapeutics fell approximately 40% intraday on Friday after the FDA identified deficiencies in its New Drug Application for Anaphylm, raising concerns about the drug's approval prospects.
- FDA Feedback: The FDA indicated that unidentified deficiencies currently hinder discussions on labeling and post-marketing requirements, which not only affects the drug's market outlook but also raises doubts about its approvability ahead of the January 31, 2026 PDUFA action date.
- Legal Consultation Opportunity: Faruqi & Faruqi is investigating potential claims against Aquestive Therapeutics and encourages investors who suffered significant losses to contact partner Josh Wilson directly for legal support to protect their rights.
- Investor Protection: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions of dollars for investors, demonstrating its strong capabilities in securities law and commitment to safeguarding investor interests.
See More
Faruqi & Faruqi Investigates Investor Losses in Aquestive Therapeutics
- Legal Investigation Launched: Faruq & Faruqi LLP is investigating potential claims against Aquestive Therapeutics, aiming to provide legal support for investors who have suffered significant losses, highlighting the legal risks the company may face.
- Investor Rights Advocacy: The firm encourages all investors who have incurred losses in Aquestive stock or options to contact partner Josh Wilson directly, demonstrating its commitment to protecting investor rights.
- Historical Performance Review: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions of dollars for investors, showcasing its strong capabilities and extensive experience in securities law, which enhances investor trust in its services.
- Contact Information Provided: Faruqi & Faruqi has made direct contact numbers available, ensuring investors can easily access legal consultation, reflecting its commitment to client service.
See More
Pomerantz LLP Investigates Securities Fraud Claims Against Aquestive Therapeutics
- Securities Fraud Investigation: Pomerantz LLP is investigating claims on behalf of investors of Aquestive Therapeutics, focusing on whether the company and its executives engaged in securities fraud or other unlawful business practices, highlighting concerns for investor rights.
- 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 regulatory compliance challenges for the company.
- Significant Stock Price Drop: Following the FDA notification, Aquestive's stock price fell by $2.30, a decline of 37.04%, closing at $3.91 per share, reflecting market concerns regarding the company's future prospects.
- Law Firm's Reputation: Pomerantz LLP, recognized as a premier firm in securities class litigation for over 85 years, focuses on fighting for the rights of victims of securities fraud and corporate misconduct, underscoring the firm's expertise and influence in the legal field.
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
