Faruqi & Faruqi Investigates Aquestive Therapeutics' FDA Application Deficiencies

Written by Emily J. Thompson, Senior Investment Analyst

AQST+7.1%

Source: Globenewswire

Updated: 4d ago

0mins

Source: Globenewswire

Stock Price Plunge: Shares of Aquestive Therapeutics fell approximately 40% intraday on Friday after the FDA identified deficiencies in its New Drug Application, raising concerns about the drug's approval prospects and investor confidence.
FDA Deficiency Warning: The FDA indicated that unidentified deficiencies hinder discussions on labeling and post-marketing requirements for Anaphylm, which not only impacts the drug's market outlook but also potentially erodes investor trust further.
Legal Consultation Opportunity: Faruqi & Faruqi encourages investors who suffered significant losses to contact them directly to discuss their legal rights, demonstrating the firm's commitment to protecting investor interests.
Historical Recovery Record: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions of dollars for investors, showcasing its expertise and successful track record in securities law, which may attract more affected investors seeking assistance.

AQST

$3.47+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 8.40 USD with a low forecast of 8.00 USD and a high forecast of 10.00 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.

5 Analyst Rating

5 Buy

0 Hold

0 Sell

Strong Buy

Current: 3.240

Low

8.00

Averages

8.40

High

10.00

Current: 3.240

Low

8.00

Averages

8.40

High

10.00

Piper Sandler

Overweight

maintain

$5 -> $8

2025-11-07

Reason

Piper Sandler

Price Target

$5 -> $8

AI Analysis

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

Outperform

maintain

$7 -> $8

2025-09-08

Reason

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.

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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

Outperform

Hold

downgrade

$15 -> $7

2025-06-02

Reason

Oppenheimer

Price Target

$15 -> $7

2025-06-02

downgrade

Outperform

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.