Aquestive Therapeutics Faces 40% Stock Drop After FDA Identifies Deficiencies in Anaphylm NDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 09 2026
0mins
Source: Benzinga
- FDA Deficiency Notification: The FDA has identified deficiencies in Aquestive's New Drug Application for Anaphylm, preventing discussions on labeling and post-marketing commitments, which could delay the approval process and impact future revenues.
- Severe Market Reaction: Following the FDA's announcement, Aquestive's stock plummeted by 40.18% to $3.71 during Friday's trading session, with a volume of 5.68 million shares traded, significantly exceeding the average of 2.79 million shares, indicating investor concerns over the approval outlook.
- Strong Cash Position: As of the end of 2025, Aquestive reported approximately $120 million in cash and cash equivalents, which is expected to be sufficient to support the approval and launch processes for Anaphylm in the U.S., contingent upon FDA approval.
- International Expansion Plans: The company aims to submit regulatory applications for Anaphylm in Canada, Europe, and the U.K. in 2026, demonstrating its commitment to advancing the product in global markets despite the challenges posed by the FDA's feedback.
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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: 4.290
Low
6.00
Averages
9.00
High
12.00
Current: 4.290
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.
Rosen Law Firm Files Class Action Against Aquestive Therapeutics
- Class Action Initiated: Rosen Law Firm has filed a class action lawsuit on behalf of investors who purchased securities of Aquestive Therapeutics (NASDAQ: AQST) between June 16, 2025, and January 8, 2026, alleging that the company concealed critical information regarding its New Drug Application, resulting in investor losses.
- Compensation Structure: Investors joining the class action will not incur any out-of-pocket expenses, as attorney fees will be covered through a contingency fee arrangement, thereby reducing the financial burden on affected investors and encouraging broader participation in the lawsuit.
- Law Firm 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, demonstrating its strength and experience in handling similar cases effectively.
- Details of Allegations: The lawsuit claims that Aquestive failed to disclose human factors involved in the use and deployment of its sublingual film, leading to investor damages when the true details became public, underscoring the importance of transparency in investment decisions.
See More
Class Action Reminder for Aquestive Therapeutics Shareholders
- 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: The complaint states that the FDA identified deficiencies in Aquestive's New Drug Application (NDA), which 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: On January 9, 2026, Aquestive announced it received a letter from the FDA confirming that its NDA review was ongoing, causing its stock price to plummet over 37% from $6.21 per share on January 8, 2026, to $3.91 per share, reflecting market pessimism about the company's future.
- Investor Action: Shareholders wishing to serve as lead plaintiffs in the class action must submit their papers by May 4, 2026, indicating their willingness to represent other shareholders in the litigation, and participation in the case is not a prerequisite for recovery.
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 Anaphylm.
- FDA Deficiencies Identified: The complaint states that the FDA identified deficiencies in Aquestive's New Drug Application (NDA) that precluded labeling discussions and post-marketing commitments, resulting in a delay of Anaphylm's approval beyond the January 31, 2026 PDUFA date.
- Stock Price Plummet: Following the announcement on January 9, 2026, that the FDA's review of the NDA was ongoing with no final decision made, Aquestive's stock price plummeted over 37%, from $6.21 per share on January 8, 2026, to $3.91 per share.
- Investor Rights: Robbins LLP offers contingency-based legal representation, allowing shareholders to participate in the class action without upfront costs, aiming to help investors recover losses and improve corporate governance.
See More
Class Action Lawsuit Filed Against Aquestive
- Lawsuit Background: Bragar Eagel & Squire has filed a class action lawsuit against Aquestive Therapeutics in New Jersey on behalf of investors who purchased securities between June 16, 2025, and January 8, 2026, indicating significant issues with the company's drug approval process.
- FDA Deficiency Disclosure: The complaint alleges that during the class period, Aquestive misled investors by claiming its New Drug Application (NDA) would receive timely FDA approval, while in reality, the FDA identified deficiencies that delayed the approval of Anaphylm.
- Stock Price Plunge: Following the announcement on January 9, 2026, that the FDA had identified deficiencies, Aquestive's stock price plummeted over 37% from $6.21 per share on January 8 to $3.91, reflecting strong market concerns about the company's future.
- Investor Action: Affected investors are encouraged to apply to be lead plaintiffs by May 4, 2026, indicating that the legal action could have significant implications for the company's financial outlook.
See More
Shareholder Class Action Filed Against Aquestive Therapeutics
- Class Action Initiation: Bernstein Liebhard LLP announces that a shareholder has filed a securities class action lawsuit against Aquestive Therapeutics, involving securities transactions from June 16, 2025, to January 8, 2026, indicating investor concerns over potential misrepresentations by the company.
- Lawsuit Allegations: The lawsuit alleges that the defendants made false statements regarding the New Drug Application for Anaphylm (Dibutepinephrine) sublingual film, which may have misled investors in their decision-making, thereby impacting their investment returns.
- Lead Plaintiff Application: Investors wishing to serve as lead plaintiffs must file papers by May 4, 2026, indicating their representative role in the litigation, reflecting a proactive approach to the lawsuit process and potential recovery efforts.
- Fee Arrangement: All representation is on a contingency fee basis, meaning shareholders incur no fees or expenses, which lowers the barrier for affected investors to participate in the lawsuit and may attract more shareholders to join the action.
See More
Securities Class Action Filed Against Aquestive Therapeutics
- Lawsuit Background: A securities class action has been filed in the U.S. District Court for New Jersey on behalf of all individuals or entities who purchased Aquestive Therapeutics (NASDAQ: AQST) securities between June 16, 2025, and January 8, 2026, highlighting significant investor concerns regarding company transparency.
- False Statement Allegations: The complaint alleges that defendants provided overly positive statements to investors while intentionally disseminating materially false and misleading information, concealing adverse facts related to the company's NDA for Anaphylm, which could lead to investor losses.
- Concealment of Human Factors: The case specifically mentions that Aquestive minimized the significance of human factors involved in the use and deployment of its sublingual film, such as packaging, use, administration, and labeling, potentially affecting market acceptance of the product.
- Investor Action Call: Investors are urged to contact the law firm before the May 4, 2026 lead plaintiff motion deadline to discuss their rights and interests in this class action, reflecting a serious approach to legal proceedings.
See More
Rosen Law Firm Files Class Action Against Aquestive Therapeutics
- Class Action Initiated: Rosen Law Firm has filed a class action lawsuit on behalf of investors who purchased securities of Aquestive Therapeutics (NASDAQ: AQST) between June 16, 2025, and January 8, 2026, alleging that the company concealed critical information regarding its New Drug Application, resulting in investor losses.
- Compensation Structure: Investors joining the class action will not incur any out-of-pocket expenses, as attorney fees will be covered through a contingency fee arrangement, thereby reducing the financial burden on affected investors and encouraging broader participation in the lawsuit.
- Law Firm 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, demonstrating its strength and experience in handling similar cases effectively.
- Details of Allegations: The lawsuit claims that Aquestive failed to disclose human factors involved in the use and deployment of its sublingual film, leading to investor damages when the true details became public, underscoring the importance of transparency in investment decisions.
See More
Class Action Reminder for Aquestive Therapeutics Shareholders
- 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: The complaint states that the FDA identified deficiencies in Aquestive's New Drug Application (NDA), which 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: On January 9, 2026, Aquestive announced it received a letter from the FDA confirming that its NDA review was ongoing, causing its stock price to plummet over 37% from $6.21 per share on January 8, 2026, to $3.91 per share, reflecting market pessimism about the company's future.
- Investor Action: Shareholders wishing to serve as lead plaintiffs in the class action must submit their papers by May 4, 2026, indicating their willingness to represent other shareholders in the litigation, and participation in the case is not a prerequisite for recovery.
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 Anaphylm.
- FDA Deficiencies Identified: The complaint states that the FDA identified deficiencies in Aquestive's New Drug Application (NDA) that precluded labeling discussions and post-marketing commitments, resulting in a delay of Anaphylm's approval beyond the January 31, 2026 PDUFA date.
- Stock Price Plummet: Following the announcement on January 9, 2026, that the FDA's review of the NDA was ongoing with no final decision made, Aquestive's stock price plummeted over 37%, from $6.21 per share on January 8, 2026, to $3.91 per share.
- Investor Rights: Robbins LLP offers contingency-based legal representation, allowing shareholders to participate in the class action without upfront costs, aiming to help investors recover losses and improve corporate governance.
See More
Class Action Lawsuit Filed Against Aquestive
- Lawsuit Background: Bragar Eagel & Squire has filed a class action lawsuit against Aquestive Therapeutics in New Jersey on behalf of investors who purchased securities between June 16, 2025, and January 8, 2026, indicating significant issues with the company's drug approval process.
- FDA Deficiency Disclosure: The complaint alleges that during the class period, Aquestive misled investors by claiming its New Drug Application (NDA) would receive timely FDA approval, while in reality, the FDA identified deficiencies that delayed the approval of Anaphylm.
- Stock Price Plunge: Following the announcement on January 9, 2026, that the FDA had identified deficiencies, Aquestive's stock price plummeted over 37% from $6.21 per share on January 8 to $3.91, reflecting strong market concerns about the company's future.
- Investor Action: Affected investors are encouraged to apply to be lead plaintiffs by May 4, 2026, indicating that the legal action could have significant implications for the company's financial outlook.
See More
Shareholder Class Action Filed Against Aquestive Therapeutics
- Class Action Initiation: Bernstein Liebhard LLP announces that a shareholder has filed a securities class action lawsuit against Aquestive Therapeutics, involving securities transactions from June 16, 2025, to January 8, 2026, indicating investor concerns over potential misrepresentations by the company.
- Lawsuit Allegations: The lawsuit alleges that the defendants made false statements regarding the New Drug Application for Anaphylm (Dibutepinephrine) sublingual film, which may have misled investors in their decision-making, thereby impacting their investment returns.
- Lead Plaintiff Application: Investors wishing to serve as lead plaintiffs must file papers by May 4, 2026, indicating their representative role in the litigation, reflecting a proactive approach to the lawsuit process and potential recovery efforts.
- Fee Arrangement: All representation is on a contingency fee basis, meaning shareholders incur no fees or expenses, which lowers the barrier for affected investors to participate in the lawsuit and may attract more shareholders to join the action.
See More
Securities Class Action Filed Against Aquestive Therapeutics
- Lawsuit Background: A securities class action has been filed in the U.S. District Court for New Jersey on behalf of all individuals or entities who purchased Aquestive Therapeutics (NASDAQ: AQST) securities between June 16, 2025, and January 8, 2026, highlighting significant investor concerns regarding company transparency.
- False Statement Allegations: The complaint alleges that defendants provided overly positive statements to investors while intentionally disseminating materially false and misleading information, concealing adverse facts related to the company's NDA for Anaphylm, which could lead to investor losses.
- Concealment of Human Factors: The case specifically mentions that Aquestive minimized the significance of human factors involved in the use and deployment of its sublingual film, such as packaging, use, administration, and labeling, potentially affecting market acceptance of the product.
- Investor Action Call: Investors are urged to contact the law firm before the May 4, 2026 lead plaintiff motion deadline to discuss their rights and interests in this class action, reflecting a serious approach to legal proceedings.
See More
