AQST Shareholder Alert: FDA Approval Delay
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 20 2026
0mins
Should l Buy AQST?
Source: Globenewswire
- Shareholder 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 them regarding potential lead plaintiff status, indicating significant legal risks for the company.
- FDA Deficiency Letter: On January 9, 2026, AQST announced it received a letter from the FDA identifying deficiencies in its New Drug Application for Anaphylm, which halted labeling discussions, directly impacting investor confidence and stock performance.
- Stock Price Plunge: Following the FDA announcement, AQST's stock price plummeted from $6.21 on January 8, 2026, to $3.91 on January 9, representing a dramatic decline of over 37% in a single day, reflecting market pessimism about the company's future.
- Lawsuit Deadline: Shareholders must register for the class action by May 4, 2026, to avoid losing their right to claim, highlighting the legal pressure on the company and the urgency for investors to act.
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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: 4.020
Low
6.00
Averages
9.00
High
12.00
Current: 4.020
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.
Aquestive Reaffirms Anaphylm NDA Resubmission Timeline
- FDA Meeting Outcomes: Aquestive's Type A meeting with the FDA confirmed key program elements for the Anaphylm NDA resubmission, expected in Q3 2026, demonstrating the company's strong commitment to addressing the treatment of allergic reactions.
- Study Design Feedback: The FDA provided preliminary comments on the pharmacokinetic (PK) and human factors (HF) study designs, emphasizing consistency with past studies, which enhances the likelihood of future approval by ensuring scientific rigor and effectiveness.
- Packaging Improvements: The company showcased improvements to the Anaphylm product packaging during the meeting, aimed at enhancing ease of opening and reducing film tearing risks, which received FDA acknowledgment and will be tested in the upcoming human factors study.
- International Market Expansion: In addition to the U.S., Aquestive is advancing regulatory submissions for Anaphylm in Canada and the European Union, indicating the company's commitment to bringing this innovative drug to the global market to meet the growing demand for allergy treatments.
See More
Class Action Lawsuit Filed Against Aquestive
- Lawsuit Background: Bragar Eagel & Squire, P.C. has initiated a class action lawsuit against Aquestive Therapeutics on behalf of investors who purchased securities between June 16, 2025, and January 8, 2026, reflecting disappointment over the company's failure to secure timely approval for its new drug Anaphylm.
- FDA Deficiency Disclosure: The lawsuit highlights that on January 9, 2026, the FDA confirmed deficiencies in Aquestive's New Drug Application, leading to delays in Anaphylm's launch, which directly impacted investor confidence and stock price.
- Stock Price Plunge: Following the FDA announcement, Aquestive's stock price plummeted over 37%, from $6.21 per share on January 8, 2026, to $3.91, indicating a pessimistic outlook from the market regarding the company's future.
- Investor Action: Investors are urged to apply by May 4, 2026, to be appointed as lead plaintiffs, highlighting concerns over corporate governance and transparency, which may influence future investment decisions.
See More
Reminder of Class Action Lawsuit 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 the law firm operates on a contingency fee basis, allowing investors to pursue compensation without financial burden.
- Case Background: The lawsuit alleges that the defendants failed to disclose critical human factors related to the use of Aquestive's New Drug Application (NDA) for its sublingual film, resulting in investor losses when the truth emerged, highlighting significant deficiencies in the company's transparency and compliance.
- Law Firm's Strength: 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 expertise and resource advantages in handling similar cases.
See More
Faruqi & Faruqi Encourages Investors to Contact Regarding Aquestive Losses
- Legal Investigation: Faruq & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc. for securities purchased between June 16, 2025, and January 8, 2026, highlighting concerns for investor rights.
- Investor Contact Information: Securities Litigation Partner Josh Wilson encourages affected investors to reach out directly, providing contact numbers 877-247-4292 and 212-983-9330 (Ext. 1310) to discuss legal options, demonstrating a commitment to client service.
- Class Action Deadline: Investors should note that May 4, 2026, is the deadline to seek the role of lead plaintiff in a federal securities class action against the company, making this date critical for potential claimants.
- Company Background: Aquestive Therapeutics, Inc. (NASDAQ:AQST) focuses on drug delivery technologies and is currently facing legal challenges that may impact investor confidence and market performance.
See More
Rosen Law Firm Alerts Investors of Class Action for Aquestive Therapeutics
- 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 incur no out-of-pocket costs, as the law firm operates on a contingency fee basis, which mitigates financial risk for investors and encourages broader participation.
- Case Background: The lawsuit alleges that the defendants failed to disclose the true state of Aquestive's New Drug Application (NDA), particularly concealing human factors related to the use of its sublingual film, resulting in investor losses when the truth emerged, highlighting significant governance and transparency issues within the company.
- Law Firm's Strength: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, and was ranked first in 2017 for the number of securities class action settlements, demonstrating its expertise and influence in this field.
See More
Reminder of Class Action 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, to apply as lead plaintiffs by May 4, 2026, to participate in the class action and potentially receive compensation.
- Fee Arrangement: Investors joining the class action will not incur any upfront costs, as the law firm operates on a contingency fee basis, allowing them to seek legal recourse without financial burden.
- Case Background: The lawsuit alleges that the defendants made false or misleading statements regarding the New Drug Application (NDA) process, failing to disclose critical human factors involved in the use of their sublingual film, resulting in investor losses when the truth emerged.
- Law Firm's Strength: Rosen Law Firm specializes in securities class actions, having recovered over $438 million for investors in 2019 alone, and was ranked first by ISS Securities Class Action Services in 2017, highlighting its expertise and success in this field.
See More
Aquestive Reaffirms Anaphylm NDA Resubmission Timeline
- FDA Meeting Outcomes: Aquestive's Type A meeting with the FDA confirmed key program elements for the Anaphylm NDA resubmission, expected in Q3 2026, demonstrating the company's strong commitment to addressing the treatment of allergic reactions.
- Study Design Feedback: The FDA provided preliminary comments on the pharmacokinetic (PK) and human factors (HF) study designs, emphasizing consistency with past studies, which enhances the likelihood of future approval by ensuring scientific rigor and effectiveness.
- Packaging Improvements: The company showcased improvements to the Anaphylm product packaging during the meeting, aimed at enhancing ease of opening and reducing film tearing risks, which received FDA acknowledgment and will be tested in the upcoming human factors study.
- International Market Expansion: In addition to the U.S., Aquestive is advancing regulatory submissions for Anaphylm in Canada and the European Union, indicating the company's commitment to bringing this innovative drug to the global market to meet the growing demand for allergy treatments.
See More
Class Action Lawsuit Filed Against Aquestive
- Lawsuit Background: Bragar Eagel & Squire, P.C. has initiated a class action lawsuit against Aquestive Therapeutics on behalf of investors who purchased securities between June 16, 2025, and January 8, 2026, reflecting disappointment over the company's failure to secure timely approval for its new drug Anaphylm.
- FDA Deficiency Disclosure: The lawsuit highlights that on January 9, 2026, the FDA confirmed deficiencies in Aquestive's New Drug Application, leading to delays in Anaphylm's launch, which directly impacted investor confidence and stock price.
- Stock Price Plunge: Following the FDA announcement, Aquestive's stock price plummeted over 37%, from $6.21 per share on January 8, 2026, to $3.91, indicating a pessimistic outlook from the market regarding the company's future.
- Investor Action: Investors are urged to apply by May 4, 2026, to be appointed as lead plaintiffs, highlighting concerns over corporate governance and transparency, which may influence future investment decisions.
See More
Reminder of Class Action Lawsuit 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 the law firm operates on a contingency fee basis, allowing investors to pursue compensation without financial burden.
- Case Background: The lawsuit alleges that the defendants failed to disclose critical human factors related to the use of Aquestive's New Drug Application (NDA) for its sublingual film, resulting in investor losses when the truth emerged, highlighting significant deficiencies in the company's transparency and compliance.
- Law Firm's Strength: 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 expertise and resource advantages in handling similar cases.
See More
Faruqi & Faruqi Encourages Investors to Contact Regarding Aquestive Losses
- Legal Investigation: Faruq & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc. for securities purchased between June 16, 2025, and January 8, 2026, highlighting concerns for investor rights.
- Investor Contact Information: Securities Litigation Partner Josh Wilson encourages affected investors to reach out directly, providing contact numbers 877-247-4292 and 212-983-9330 (Ext. 1310) to discuss legal options, demonstrating a commitment to client service.
- Class Action Deadline: Investors should note that May 4, 2026, is the deadline to seek the role of lead plaintiff in a federal securities class action against the company, making this date critical for potential claimants.
- Company Background: Aquestive Therapeutics, Inc. (NASDAQ:AQST) focuses on drug delivery technologies and is currently facing legal challenges that may impact investor confidence and market performance.
See More
Rosen Law Firm Alerts Investors of Class Action for Aquestive Therapeutics
- 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 incur no out-of-pocket costs, as the law firm operates on a contingency fee basis, which mitigates financial risk for investors and encourages broader participation.
- Case Background: The lawsuit alleges that the defendants failed to disclose the true state of Aquestive's New Drug Application (NDA), particularly concealing human factors related to the use of its sublingual film, resulting in investor losses when the truth emerged, highlighting significant governance and transparency issues within the company.
- Law Firm's Strength: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, and was ranked first in 2017 for the number of securities class action settlements, demonstrating its expertise and influence in this field.
See More
Reminder of Class Action 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, to apply as lead plaintiffs by May 4, 2026, to participate in the class action and potentially receive compensation.
- Fee Arrangement: Investors joining the class action will not incur any upfront costs, as the law firm operates on a contingency fee basis, allowing them to seek legal recourse without financial burden.
- Case Background: The lawsuit alleges that the defendants made false or misleading statements regarding the New Drug Application (NDA) process, failing to disclose critical human factors involved in the use of their sublingual film, resulting in investor losses when the truth emerged.
- Law Firm's Strength: Rosen Law Firm specializes in securities class actions, having recovered over $438 million for investors in 2019 alone, and was ranked first by ISS Securities Class Action Services in 2017, highlighting its expertise and success in this field.
See More
