FDA Advisory Committee Update: The FDA has informed Aquestive Therapeutics that an advisory committee meeting is not necessary for their product Anaphylm (dibutepinephrine) Sublingual Film, with a target action date set for January 31, 2026.
Product Overview and Clinical Trials: Anaphylm aims to be the first FDA-approved, non-invasive, orally delivered epinephrine option for severe allergic reactions, having completed eleven clinical studies demonstrating safety and effectiveness, particularly in pediatric patients.
AQST
$5.82+Infinity%1D
Analyst Views on AQST
Wall Street analysts forecast AQST stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for AQST is 9.50 USD with a low forecast of 8.00 USD and a high forecast of 12.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
7 Analyst Rating
Wall Street analysts forecast AQST stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for AQST is 9.50 USD with a low forecast of 8.00 USD and a high forecast of 12.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 5.910
Low
8.00
Averages
9.50
High
12.00
Current: 5.910
Low
8.00
Averages
9.50
High
12.00
Piper Sandler
Overweight
maintain
$5 -> $8
2025-11-07
Reason
Piper Sandler
Price Target
$5 -> $8
2025-11-07
maintain
Overweight
Reason
Piper Sandler raised the firm's price target on Aquestive Therapeutics to $8 from $5 and keeps an Overweight rating on the shares after hosting a fireside chat with the company's senior leadership ahead of data presentations for Anaphylm at the upcoming American College of Allergy, Asthma and Immunology meeting. Key discussion topics included the body of data surrounding the product; the NDA review process; and commercial launch plans. Piper remains confident in a timely FDA approval of Anaphylm, and believes the product will be met with an enthusiastic prescriber audience.
Oppenheimer
Oppenheimer
Outperform
maintain
$7 -> $8
2025-09-08
Reason
Oppenheimer
Oppenheimer
Price Target
$7 -> $8
2025-09-08
maintain
Outperform
Reason
Oppenheimer raised the firm's price target on Aquestive Therapeutics to $8 from $7 and keeps an Outperform rating on the shares. The firm notes that last week, Aquestive announced that the FDA would not require an AdCom for its NDA of Anaphylm sending shares up +43.77% as investors interpret the update increasing the chances of approval. While Oppenheimer saw an AdCom as likely and increasing the path to approval given the established approval path with neffy and Analphylm's novel route of administration, it appears the data package submitted suffices in guiding the FDA on addressing key topics for potential approval without the need for expert recommendations.
LifeSci Capital
initiated
$10
2025-09-03
Reason
LifeSci Capital
Price Target
$10
2025-09-03
initiated
Reason
LifeSci Capital initiated coverage of Aquestive Therapeutics with an Outperform rating and $10 price target.
Oppenheimer
Oppenheimer
Outperform
to
Hold
downgrade
$15 -> $7
2025-06-02
Reason
Oppenheimer
Oppenheimer
Price Target
$15 -> $7
2025-06-02
downgrade
Outperform
to
Hold
Reason
Oppenheimer lowered the firm's price target on Aquestive Therapeutics to $7 from $15 and keeps an Outperform rating on the shares following quarterly results. With the Anaphylm NDA submitted on April 1, management expects an FDA response next month and a potential action date in late January/early February 2026. Preparations for a potential AdCom are ongoing. The firm is encouraged by ongoing commercialization efforts, including commercial team build-out, growing anaphylaxis awareness, and continuing payer engagements. Aquestive also plans to engage ex-U.S. regulators and pursue partnerships to strengthen its balance sheet, adds Oppenheimer.
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.
