Aquestive Therapeutics Stock Soars 43% Following FDA Complete Response Letter
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 02 2026
0mins
Should l Buy AQST?
Source: NASDAQ.COM
- Significant Stock Surge: Aquestive Therapeutics, Inc. (AQST) saw its stock price soar approximately 43% in Monday morning trading, rising from $2.95 to $4.22, indicating strong market optimism regarding its new drug application.
- Trading Fluctuations: The stock opened at $3.79 and reached a high of $4.39 during today's session, with a yearly trading range of $2.12 to $7.55, reflecting investor confidence in the company's future prospects.
- FDA Feedback and Next Steps: The company received a Complete Response Letter from the FDA regarding its New Drug Application for Anaphylm Sublingual Film, and plans to request a Type A meeting with the FDA to discuss the most efficient path for resubmission, expected in Q3 2026.
- Request for Expedited Review: Following the initial review of the CRL, Aquestive Therapeutics intends to request rapid review by the FDA, aiming to accelerate the drug's market entry to meet the urgent demand for treatments of allergic reactions.
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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: 4.120
Low
6.00
Averages
9.00
High
12.00
Current: 4.120
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 Therapeutics to Announce Q4 Earnings on March 4
- Earnings Announcement: Aquestive Therapeutics is set to release its Q4 earnings on March 4, with consensus EPS estimates at -$0.13 and revenue expectations of $13.28 million, reflecting an 11.9% year-over-year growth, which will provide investors with insights into the company's financial health.
- FDA Complete Response: The company has discussed the FDA's Complete Response Letter regarding the Anaphylm epinephrine sublingual film and its next steps, indicating a commitment to product launch despite regulatory challenges, which may influence future market strategies.
- Market Reaction Volatility: Despite receiving the FDA's Complete Response Letter, Aquestive's stock experienced a jump, demonstrating market confidence in the company's future potential; however, the FDA's flagged issues in the Anaphylm marketing application also led to a stock drop, reflecting investor sensitivity to regulatory risks.
- Product Outlook Uncertainty: The marketing application for Anaphylm faces scrutiny from the FDA, and while the company is working to address these issues, short-term impacts on market performance and investor confidence are likely, necessitating close monitoring of future developments.
See More
Aquestive Therapeutics Q4 Earnings Report Analysis
- Disappointing Earnings: Aquestive Therapeutics reported a Q4 GAAP EPS of -$0.26, missing expectations by $0.13, indicating ongoing challenges in profitability that may undermine investor confidence.
- Lackluster Revenue Growth: The company generated $13 million in revenue for Q4, a 9.5% year-over-year increase, yet fell short of expectations by $280,000, suggesting that market demand did not meet projections, potentially impacting future sales strategies.
- 2026 Financial Outlook: Aquestive anticipates total revenue between $46 million and $50 million for 2026, with a non-GAAP adjusted EBITDA loss projected between $30 million and $35 million, reflecting challenges in restoring profitability.
- FDA Feedback Impact: Following the FDA's Complete Response Letter regarding the Anaphylm sublingual film, the company faces uncertainty in product launch, which could negatively affect future revenues and market share.
See More
Faruqi & Faruqi Investigates Losses in Aquestive Therapeutics
- Stock Price Plunge: Shares of Aquestive Therapeutics fell approximately 40% intraday on Friday after the FDA identified deficiencies in its New Drug Application, which directly impacted investor confidence and triggered significant sell-offs.
- FDA Warning: The FDA indicated that unidentified deficiencies hinder discussions on labeling and post-marketing requirements for Anaphylm, which not only affects the drug's approval prospects but may also delay its market launch, putting future revenue under pressure.
- Legal Consultation Opportunity: Faruqi & Faruqi is investigating potential claims against Aquestive, encouraging investors who suffered significant losses to contact them directly, indicating the firm's commitment to investor rights and potentially leading to more legal actions.
- Investor Losses: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions for investors, and the current investigation may provide legal support for affected investors seeking compensation.
See More
Aquestive Therapeutics to Present at Oppenheimer Conference
- Conference Participation: Aquestive Therapeutics will participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, showcasing its advancements in innovative drug delivery technologies, which is expected to attract investor interest.
- Management Presentation: The company's management team will present on February 26 at 12 PM ET and will host one-on-one meetings with investors, aiming to enhance engagement and increase market awareness.
- Webcast Availability: The presentation will be available via a webcast on the company's website under the 'Events and Presentations' section, with a replay accessible for 30 days post-event, ensuring that investors who cannot attend live can still access critical information.
- Product Development Outlook: As a global leader in oral film medications, Aquestive is advancing its AdrenaVerse™ platform to develop various potential allergy and dermatological drugs, demonstrating its innovative capabilities and market potential in the pharmaceutical industry.
See More
Anaphylm™ Sublingual Film Clinical Data Released
- Clinical Data Presentation: Aquestive Therapeutics showcased clinical data for Anaphylm™ (dibutepinephrine) sublingual film at the 2026 AAAAI Annual Meeting, highlighting its potential to transform severe allergic reaction management, which could significantly improve patient outcomes.
- Blood Pressure Response Advantage: The study revealed that sublingual administration of Anaphylm did not result in a dip in diastolic blood pressure, a clinically significant finding that enhances understanding of the hemodynamic response to sublingual epinephrine, thereby reducing treatment risks associated with anaphylaxis.
- Product Portability: Anaphylm is designed to be the size of a postage stamp and weighs less than an ounce, making it easy to carry without the need for water or swallowing, which is expected to address both psychological and practical barriers faced by patients in carrying and using epinephrine.
- FDA Approval Prospects: If approved by the FDA, Anaphylm would be the first oral medication for severe allergic reactions, representing a significant innovation in the field and potentially offering patients a more convenient treatment option.
See More
Aquestive Therapeutics Appoints New Chief Medical Officer
- Executive Appointment: Aquestive Therapeutics has appointed Matthew Greenhawt as Chief Medical Officer, an internationally recognized expert in allergy and immunology, particularly in food allergies and anaphylaxis, which will enhance the company's medical leadership.
- Transition of Leadership: Greenhawt takes over from Gary Slatko, who served as interim Chief Medical Officer, ensuring continuity and stability in the company's medical strategy during this transition.
- Extensive Experience: Prior to joining Aquestive, Greenhawt was the Chief Medical Officer of the Asthma and Allergy Foundation of America and a Professor of Pediatrics at Children's Hospital Colorado and the University of Colorado School of Medicine, bringing valuable expertise to drive the company's R&D and market strategies.
- Market Reaction: Following the announcement, AQST shares rose by 0.52% in pre-market trading on Nasdaq, reaching $3.90, reflecting positive market expectations regarding the new Chief Medical Officer's potential impact.
See More
Aquestive Therapeutics to Announce Q4 Earnings on March 4
- Earnings Announcement: Aquestive Therapeutics is set to release its Q4 earnings on March 4, with consensus EPS estimates at -$0.13 and revenue expectations of $13.28 million, reflecting an 11.9% year-over-year growth, which will provide investors with insights into the company's financial health.
- FDA Complete Response: The company has discussed the FDA's Complete Response Letter regarding the Anaphylm epinephrine sublingual film and its next steps, indicating a commitment to product launch despite regulatory challenges, which may influence future market strategies.
- Market Reaction Volatility: Despite receiving the FDA's Complete Response Letter, Aquestive's stock experienced a jump, demonstrating market confidence in the company's future potential; however, the FDA's flagged issues in the Anaphylm marketing application also led to a stock drop, reflecting investor sensitivity to regulatory risks.
- Product Outlook Uncertainty: The marketing application for Anaphylm faces scrutiny from the FDA, and while the company is working to address these issues, short-term impacts on market performance and investor confidence are likely, necessitating close monitoring of future developments.
See More
Aquestive Therapeutics Q4 Earnings Report Analysis
- Disappointing Earnings: Aquestive Therapeutics reported a Q4 GAAP EPS of -$0.26, missing expectations by $0.13, indicating ongoing challenges in profitability that may undermine investor confidence.
- Lackluster Revenue Growth: The company generated $13 million in revenue for Q4, a 9.5% year-over-year increase, yet fell short of expectations by $280,000, suggesting that market demand did not meet projections, potentially impacting future sales strategies.
- 2026 Financial Outlook: Aquestive anticipates total revenue between $46 million and $50 million for 2026, with a non-GAAP adjusted EBITDA loss projected between $30 million and $35 million, reflecting challenges in restoring profitability.
- FDA Feedback Impact: Following the FDA's Complete Response Letter regarding the Anaphylm sublingual film, the company faces uncertainty in product launch, which could negatively affect future revenues and market share.
See More
Faruqi & Faruqi Investigates Losses in Aquestive Therapeutics
- Stock Price Plunge: Shares of Aquestive Therapeutics fell approximately 40% intraday on Friday after the FDA identified deficiencies in its New Drug Application, which directly impacted investor confidence and triggered significant sell-offs.
- FDA Warning: The FDA indicated that unidentified deficiencies hinder discussions on labeling and post-marketing requirements for Anaphylm, which not only affects the drug's approval prospects but may also delay its market launch, putting future revenue under pressure.
- Legal Consultation Opportunity: Faruqi & Faruqi is investigating potential claims against Aquestive, encouraging investors who suffered significant losses to contact them directly, indicating the firm's commitment to investor rights and potentially leading to more legal actions.
- Investor Losses: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions for investors, and the current investigation may provide legal support for affected investors seeking compensation.
See More
Aquestive Therapeutics to Present at Oppenheimer Conference
- Conference Participation: Aquestive Therapeutics will participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, showcasing its advancements in innovative drug delivery technologies, which is expected to attract investor interest.
- Management Presentation: The company's management team will present on February 26 at 12 PM ET and will host one-on-one meetings with investors, aiming to enhance engagement and increase market awareness.
- Webcast Availability: The presentation will be available via a webcast on the company's website under the 'Events and Presentations' section, with a replay accessible for 30 days post-event, ensuring that investors who cannot attend live can still access critical information.
- Product Development Outlook: As a global leader in oral film medications, Aquestive is advancing its AdrenaVerse™ platform to develop various potential allergy and dermatological drugs, demonstrating its innovative capabilities and market potential in the pharmaceutical industry.
See More
Anaphylm™ Sublingual Film Clinical Data Released
- Clinical Data Presentation: Aquestive Therapeutics showcased clinical data for Anaphylm™ (dibutepinephrine) sublingual film at the 2026 AAAAI Annual Meeting, highlighting its potential to transform severe allergic reaction management, which could significantly improve patient outcomes.
- Blood Pressure Response Advantage: The study revealed that sublingual administration of Anaphylm did not result in a dip in diastolic blood pressure, a clinically significant finding that enhances understanding of the hemodynamic response to sublingual epinephrine, thereby reducing treatment risks associated with anaphylaxis.
- Product Portability: Anaphylm is designed to be the size of a postage stamp and weighs less than an ounce, making it easy to carry without the need for water or swallowing, which is expected to address both psychological and practical barriers faced by patients in carrying and using epinephrine.
- FDA Approval Prospects: If approved by the FDA, Anaphylm would be the first oral medication for severe allergic reactions, representing a significant innovation in the field and potentially offering patients a more convenient treatment option.
See More
Aquestive Therapeutics Appoints New Chief Medical Officer
- Executive Appointment: Aquestive Therapeutics has appointed Matthew Greenhawt as Chief Medical Officer, an internationally recognized expert in allergy and immunology, particularly in food allergies and anaphylaxis, which will enhance the company's medical leadership.
- Transition of Leadership: Greenhawt takes over from Gary Slatko, who served as interim Chief Medical Officer, ensuring continuity and stability in the company's medical strategy during this transition.
- Extensive Experience: Prior to joining Aquestive, Greenhawt was the Chief Medical Officer of the Asthma and Allergy Foundation of America and a Professor of Pediatrics at Children's Hospital Colorado and the University of Colorado School of Medicine, bringing valuable expertise to drive the company's R&D and market strategies.
- Market Reaction: Following the announcement, AQST shares rose by 0.52% in pre-market trading on Nasdaq, reaching $3.90, reflecting positive market expectations regarding the new Chief Medical Officer's potential impact.
See More
