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: 4.320
Low
6.00
Averages
9.00
High
12.00
Current: 4.320
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 Notice for Aquestive Therapeutics Investors
- 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 seek compensation.
- Fee Arrangement: Investors joining the class action will incur no out-of-pocket costs, as attorney fees will be covered through a contingency fee arrangement, thereby lowering the financial barrier for participation and encouraging more investors to seek justice.
- Lawsuit Background: The lawsuit alleges that defendants made false and misleading statements regarding the New Drug Application (NDA) process, failing to disclose critical human factors in the use of their sublingual film, which led to investor losses when the truth emerged, negatively impacting the company's reputation and stock price.
- Law Firm's Strength: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, being ranked first in 2017 for the number of securities class action settlements, demonstrating its expertise and successful track record in this legal domain.
See More
Reminder of Class Action Lawsuit for Aquestive Securities
- Class Action Notification: 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 seek compensation.
- Fee Arrangement: Investors joining the class action will not incur any upfront costs, as the law firm will operate on a contingency fee basis, ensuring legal support without financial burden for the investors.
- Case Background: The lawsuit alleges that the defendants failed to disclose the true state of Aquestive's New Drug Application, particularly concealing human factors related to the use of its sublingual film, which led to investor losses when the truth emerged, negatively impacting the company's reputation and stock price.
- Law Firm Advantages: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, being ranked first in the number of securities class action settlements in 2017, demonstrating its expertise and success in this field.
See More
Class Action Lawsuit Filed Against Aquestive Therapeutics
- Lawsuit Background: Bronstein, Gewirtz & Grossman, LLC has announced a class action lawsuit against Aquestive Therapeutics, seeking damages for investors who purchased securities between June 16, 2025, and January 8, 2026, reflecting growing concerns about the company's future prospects.
- False Statement Allegations: The complaint alleges that the company made materially false and misleading statements during the relevant period, failing to disclose that the timeline for the approval and launch of its New Drug Application (NDA) was significantly overstated, which could further undermine investor confidence in the company.
- Concealed Human Factor Risks: The lawsuit also points out that Defendants concealed significant human factor risks associated with the use of the sublingual film, including issues related to packaging, administration, and labeling, which could materially impact the likelihood and timing of regulatory approval, exacerbating the risk of investor losses.
- Investor Action Recommendation: Affected investors are encouraged to apply to be lead plaintiffs by May 4, 2026, although they do not need to serve in this role to share in any potential recovery, indicating that legal avenues are available for investors to recover losses.
See More
Faruqi & Faruqi Encourages Investors to Contact Regarding Aquestive Losses
- Legal Investigation: Faruq & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc., particularly for investors who purchased or acquired securities between June 16, 2025, and January 8, 2026, indicating legal risks that could impact the company's stock performance.
- Investor Contact Information: Securities Litigation Partner Josh Wilson encourages affected investors to contact him directly, providing phone numbers 877-247-4292 and 212-983-9330 (Ext. 1310) to discuss their legal rights, demonstrating a commitment to investor advocacy.
- Class Action Deadline: The firm reminds investors that May 4, 2026, is the deadline to seek the role of lead plaintiff in a federal securities class action filed against Aquestive, highlighting the time-sensitive nature of legal proceedings for investors.
- Potential Impact: Such legal actions may lead to liability for the company, affecting its market reputation and shareholder confidence, prompting investors to closely monitor developments to assess their investment risks.
See More
Class Action Lawsuit Filed Against Aquestive Therapeutics
- Class Action Initiation: Pomerantz LLP has announced a class action lawsuit against Aquestive Therapeutics, alleging securities fraud by the company and certain executives, with investors needing to apply as Lead Plaintiff by May 4, 2026.
- FDA Approval Delay: On January 9, 2026, Aquestive received a letter from the FDA identifying deficiencies in the NDA for Anaphylm (Dibutepinephrine), preventing labeling discussions and leading to indefinite delays in approval, which could impact future product launches.
- Significant Stock Drop: Following the FDA news, Aquestive's stock price fell by $2.30, or 37.04%, closing at $3.91 per share on January 9, 2026, indicating market concerns regarding the company's future prospects.
- Legal Firm Background: Pomerantz LLP is a prominent law firm specializing in securities class actions, founded over 85 years ago, and has a history of recovering multimillion-dollar damages for victims of securities fraud, underscoring its commitment to protecting investor rights.
See More
Shareholder Alert for Aquestive Therapeutics
- Shareholder Action Notice: The Gross Law Firm has issued a notice encouraging shareholders who purchased AQST shares between June 16, 2025, and January 8, 2026, to contact the firm regarding potential lead plaintiff appointment, facilitating participation in possible recovery.
- FDA Regulatory Issues: On January 9, 2026, Aquestive disclosed receipt of a letter from the FDA identifying deficiencies in its New Drug Application, which precluded labeling discussions and significantly delayed the approval timeline for Anaphylm, undermining investor confidence.
- Stock Price Plunge: Following the FDA notification, AQST's stock price plummeted from $6.21 per share on January 8, 2026, to $3.91 per share on January 9, 2026, marking a dramatic decline of over 37% in a single day, reflecting market pessimism regarding the company's future prospects.
- Litigation Participation Deadline: Shareholders must register by May 4, 2026, to participate in the class action lawsuit, with the Gross Law Firm committed to providing portfolio monitoring services to keep investors informed about the case's progress and protect their rights.
See More
Class Action Notice for Aquestive Therapeutics Investors
- 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 seek compensation.
- Fee Arrangement: Investors joining the class action will incur no out-of-pocket costs, as attorney fees will be covered through a contingency fee arrangement, thereby lowering the financial barrier for participation and encouraging more investors to seek justice.
- Lawsuit Background: The lawsuit alleges that defendants made false and misleading statements regarding the New Drug Application (NDA) process, failing to disclose critical human factors in the use of their sublingual film, which led to investor losses when the truth emerged, negatively impacting the company's reputation and stock price.
- Law Firm's Strength: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, being ranked first in 2017 for the number of securities class action settlements, demonstrating its expertise and successful track record in this legal domain.
See More
Reminder of Class Action Lawsuit for Aquestive Securities
- Class Action Notification: 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 seek compensation.
- Fee Arrangement: Investors joining the class action will not incur any upfront costs, as the law firm will operate on a contingency fee basis, ensuring legal support without financial burden for the investors.
- Case Background: The lawsuit alleges that the defendants failed to disclose the true state of Aquestive's New Drug Application, particularly concealing human factors related to the use of its sublingual film, which led to investor losses when the truth emerged, negatively impacting the company's reputation and stock price.
- Law Firm Advantages: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, being ranked first in the number of securities class action settlements in 2017, demonstrating its expertise and success in this field.
See More
Class Action Lawsuit Filed Against Aquestive Therapeutics
- Lawsuit Background: Bronstein, Gewirtz & Grossman, LLC has announced a class action lawsuit against Aquestive Therapeutics, seeking damages for investors who purchased securities between June 16, 2025, and January 8, 2026, reflecting growing concerns about the company's future prospects.
- False Statement Allegations: The complaint alleges that the company made materially false and misleading statements during the relevant period, failing to disclose that the timeline for the approval and launch of its New Drug Application (NDA) was significantly overstated, which could further undermine investor confidence in the company.
- Concealed Human Factor Risks: The lawsuit also points out that Defendants concealed significant human factor risks associated with the use of the sublingual film, including issues related to packaging, administration, and labeling, which could materially impact the likelihood and timing of regulatory approval, exacerbating the risk of investor losses.
- Investor Action Recommendation: Affected investors are encouraged to apply to be lead plaintiffs by May 4, 2026, although they do not need to serve in this role to share in any potential recovery, indicating that legal avenues are available for investors to recover losses.
See More
Faruqi & Faruqi Encourages Investors to Contact Regarding Aquestive Losses
- Legal Investigation: Faruq & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc., particularly for investors who purchased or acquired securities between June 16, 2025, and January 8, 2026, indicating legal risks that could impact the company's stock performance.
- Investor Contact Information: Securities Litigation Partner Josh Wilson encourages affected investors to contact him directly, providing phone numbers 877-247-4292 and 212-983-9330 (Ext. 1310) to discuss their legal rights, demonstrating a commitment to investor advocacy.
- Class Action Deadline: The firm reminds investors that May 4, 2026, is the deadline to seek the role of lead plaintiff in a federal securities class action filed against Aquestive, highlighting the time-sensitive nature of legal proceedings for investors.
- Potential Impact: Such legal actions may lead to liability for the company, affecting its market reputation and shareholder confidence, prompting investors to closely monitor developments to assess their investment risks.
See More
Class Action Lawsuit Filed Against Aquestive Therapeutics
- Class Action Initiation: Pomerantz LLP has announced a class action lawsuit against Aquestive Therapeutics, alleging securities fraud by the company and certain executives, with investors needing to apply as Lead Plaintiff by May 4, 2026.
- FDA Approval Delay: On January 9, 2026, Aquestive received a letter from the FDA identifying deficiencies in the NDA for Anaphylm (Dibutepinephrine), preventing labeling discussions and leading to indefinite delays in approval, which could impact future product launches.
- Significant Stock Drop: Following the FDA news, Aquestive's stock price fell by $2.30, or 37.04%, closing at $3.91 per share on January 9, 2026, indicating market concerns regarding the company's future prospects.
- Legal Firm Background: Pomerantz LLP is a prominent law firm specializing in securities class actions, founded over 85 years ago, and has a history of recovering multimillion-dollar damages for victims of securities fraud, underscoring its commitment to protecting investor rights.
See More
Shareholder Alert for Aquestive Therapeutics
- Shareholder Action Notice: The Gross Law Firm has issued a notice encouraging shareholders who purchased AQST shares between June 16, 2025, and January 8, 2026, to contact the firm regarding potential lead plaintiff appointment, facilitating participation in possible recovery.
- FDA Regulatory Issues: On January 9, 2026, Aquestive disclosed receipt of a letter from the FDA identifying deficiencies in its New Drug Application, which precluded labeling discussions and significantly delayed the approval timeline for Anaphylm, undermining investor confidence.
- Stock Price Plunge: Following the FDA notification, AQST's stock price plummeted from $6.21 per share on January 8, 2026, to $3.91 per share on January 9, 2026, marking a dramatic decline of over 37% in a single day, reflecting market pessimism regarding the company's future prospects.
- Litigation Participation Deadline: Shareholders must register by May 4, 2026, to participate in the class action lawsuit, with the Gross Law Firm committed to providing portfolio monitoring services to keep investors informed about the case's progress and protect their rights.
See More
