Aquestive faces FDA review challenges for Anaphylm
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 16 2025
0mins
Should l Buy AQST?
Aquestive Therapeutics Inc experienced a significant price drop of 38.89%, crossing below its 20-day SMA amid broader market strength, with the Nasdaq-100 up 0.35% and the S&P 500 up 0.34%.
The decline is attributed to the FDA notifying Aquestive of deficiencies in its Anaphylm NDA review, which could impact product launch timelines and market expectations. Despite this setback, Aquestive is committed to global expansion plans for Anaphylm, aiming to submit regulatory applications in Canada, Europe, and the UK in 2026. The company maintains a strong cash position of approximately $120 million, which supports its approval and launch processes.
This situation raises concerns about the potential delays in bringing Anaphylm to market, which could affect investor confidence and the company's future growth prospects.
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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: 4.220
Low
6.00
Averages
9.00
High
12.00
Current: 4.220
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.
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
Aquestive Faces Class Action Lawsuit Impacting Stock Price
- Class Action Initiated: On March 5, 2026, Levi & Korsinsky announced a class action lawsuit against Aquestive Therapeutics, targeting investors who purchased securities between June 16, 2025, and January 8, 2026, highlighting serious concerns over the company's transparency and disclosures.
- FDA Deficiency Disclosure: On January 9, 2026, Aquestive revealed it received a letter from the FDA identifying deficiencies in its New Drug Application for Anaphylm, which precluded labeling discussions and delayed the approval process beyond the January 31, 2026 deadline, undermining investor confidence.
- Stock Price Plummet: Following the FDA letter, Aquestive's stock price fell dramatically from $6.21 per share on January 8, 2026, to $3.91 on January 9, representing a decline of over 37% in a single day, reflecting market pessimism regarding the company's future prospects.
- Investor Compensation Opportunity: Levi & Korsinsky encourages AQST shareholders to step forward by the May 4, 2026 deadline to request lead plaintiff status, aiming to pursue compensation for losses caused by corporate misrepresentations, demonstrating a commitment to protecting investor rights.
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
Aquestive Faces Class Action Lawsuit Impacting Stock Price
- Class Action Initiated: On March 5, 2026, Levi & Korsinsky announced a class action lawsuit against Aquestive Therapeutics, targeting investors who purchased securities between June 16, 2025, and January 8, 2026, highlighting serious concerns over the company's transparency and disclosures.
- FDA Deficiency Disclosure: On January 9, 2026, Aquestive revealed it received a letter from the FDA identifying deficiencies in its New Drug Application for Anaphylm, which precluded labeling discussions and delayed the approval process beyond the January 31, 2026 deadline, undermining investor confidence.
- Stock Price Plummet: Following the FDA letter, Aquestive's stock price fell dramatically from $6.21 per share on January 8, 2026, to $3.91 on January 9, representing a decline of over 37% in a single day, reflecting market pessimism regarding the company's future prospects.
- Investor Compensation Opportunity: Levi & Korsinsky encourages AQST shareholders to step forward by the May 4, 2026 deadline to request lead plaintiff status, aiming to pursue compensation for losses caused by corporate misrepresentations, demonstrating a commitment to protecting investor rights.
See More
