Core Viewpoint - Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for Anaphylm™ (dibutepinephrine) Sublingual Film, which is intended for treating Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more [1][2] Group 1: FDA Response and Company Actions - The CRL highlighted deficiencies related to human factors in the Anaphylm validation study, specifically issues with pouch opening and film placement that could pose safety risks [2][3] - The company plans to modify the pouch design and labeling, and conduct a new human factors validation study to address the FDA's concerns [2][4] - No additional studies were requested by the FDA, and the company believes it can resolve the identified deficiencies quickly, aiming for resubmission in Q3 2026 [3][6] Group 2: Clinical Development and Market Strategy - The original NDA submission for Anaphylm is supported by a comprehensive clinical program involving 11 studies with approximately 967 administrations across 411 subjects, demonstrating a comparable pharmacokinetic profile to leading epinephrine auto-injectors [7][8] - The company is advancing its global expansion strategy for Anaphylm, with regulatory engagements initiated in Canada, Europe, and the UK, expecting to submit applications in the second half of 2026 [5][6] Group 3: Financial Position and Future Outlook - The company remains well-capitalized and anticipates ending 2026 with significant cash reserves, which will support the Anaphylm approval and pre-launch processes in the U.S. and other key markets [6][9] - The company is committed to bringing Anaphylm to the allergy community and believes in its potential as a non-invasive treatment option for severe allergic reactions [2][8]

Core Viewpoint - Levi & Korsinsky has initiated an investigation into Aquestive Therapeutics, Inc. for potential violations of federal securities laws following the FDA's identification of deficiencies in its NDA application for Anaphylm, impacting the company's stock price significantly [1][2]. Group 1: Company Overview - Aquestive Therapeutics, Inc. is facing scrutiny after receiving a letter from the FDA on January 9, 2026, which highlighted deficiencies in its NDA application that prevent further discussions on labeling and post-market commitments for its product Anaphylm, intended for emergency treatment of anaphylaxis [1]. - Following the FDA's announcement, Aquestive's stock price dropped by $2.18, representing a 35.1% decline, opening at $4.03 [2]. Group 2: Legal and Financial Implications - The investigation by Levi & Korsinsky is aimed at exploring potential recovery options for investors who may have suffered losses due to the recent developments concerning Aquestive Therapeutics [2]. - Levi & Korsinsky LLP has a strong reputation in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years, and is recognized as one of the top securities litigation firms in the United States [3].

Core Insights - Aquestive Therapeutics, Inc. experienced a significant stock decline of approximately 40% after the FDA identified deficiencies in its New Drug Application for Anaphylm, an experimental treatment for severe allergic reactions [5] Company Overview - Aquestive Therapeutics is a biopharmaceutical company focused on developing innovative treatments for patients with severe allergic reactions [5] Regulatory Concerns - The FDA's identification of deficiencies in the NDA for Anaphylm has raised concerns regarding the application's approvability ahead of the January 31, 2026, PDUFA action date [5]

Group 1 - Aquestive Therapeutics, Inc. is under investigation by Levi & Korsinsky for potential violations of federal securities laws following an FDA letter identifying deficiencies in its NDA application for Anaphylm [1] - On January 9, 2026, the FDA's letter precluded labeling discussions and post-market commitments for Anaphylm, which is intended for the emergency treatment of anaphylaxis [1] - Following this news, Aquestive's stock price dropped by $2.18, a decline of 35.1%, opening at $4.03 [2] Group 2 - Levi & Korsinsky LLP has a strong reputation in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [3] - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the United States [3]

Core Viewpoint - Shares of Aquestive Therapeutics, Inc. (NASDAQ: AQST) dropped approximately 40% intraday following the FDA's identification of deficiencies in its New Drug Application (NDA) for Anaphylm, an experimental treatment for severe allergic reactions, including anaphylaxis [1] Group 1 - The FDA's findings prevent discussions regarding labeling and post-marketing requirements, raising concerns about the approvability of the application ahead of the January 31, 2026, PDUFA action date [1]

Core Viewpoint - Aquestive Therapeutics, Inc. has faced a significant decline in its stock price due to the FDA identifying deficiencies in its New Drug Application for Anaphylm, raising concerns about the drug's approvability ahead of the upcoming PDUFA action date [5]. Group 1: Company Overview - Aquestive Therapeutics, Inc. is a biopharmaceutical company focused on developing innovative therapies for patients with severe allergic reactions [5]. - The company's stock is traded on NASDAQ under the ticker symbol AQST [4]. Group 2: Recent Developments - Shares of Aquestive Therapeutics plunged approximately 40% intraday following the FDA's notification regarding deficiencies in its New Drug Application for Anaphylm [5]. - The FDA's findings currently prevent discussions on labeling and post-marketing requirements, which raises concerns about the application's likelihood of approval [5]. Group 3: Legal Implications - Faruqi & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics for investors who suffered significant losses due to the recent stock decline [4][5]. - The law firm has a history of recovering hundreds of millions of dollars for investors since its establishment in 1995 [4].

NEW YORK, Jan. 22, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Aquestive Therapeutics, Inc. ("Aquestive" or the "Company") (NASDAQ: AQST).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether Aquestive and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On Ja ...

… Last Friday, Aquestive got slapped down by the FDA, and the stock plunged 37% in a single session before losing another 15% this week… Despite the ambiguous slap down from the FDA, Aquestive maintains that all of its engagement with the FDA has been ‘highly collaborative.’ And the management said that since they received the letter, the FDA has repeatedly said the review of Anaphylm remains ongoing. These guys still sound really confident about their drug and their ability to get it approved both here and ...

Core Insights - Aquestive Therapeutics, Inc. experienced a significant stock decline of approximately 40% intraday following the disclosure of deficiencies identified by the U.S. Food and Drug Administration (FDA) in its New Drug Application (NDA) for Anaphylm, an experimental treatment for severe allergic reactions [5] Group 1 - The FDA's identification of deficiencies prevents discussions regarding labeling and post-marketing requirements, raising concerns about the approvability of the NDA ahead of the January 31, 2026, PDUFA action date [5] - Faruqi & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics for investors who suffered significant losses [2][4]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Aquestive Therapeutics, Inc. for possible violations of federal securities laws and unlawful business practices following a significant stock price drop due to FDA notification of deficiencies in a New Drug Application [1][2]. Investigation Details - On January 9, 2026, Aquestive disclosed that the FDA identified deficiencies in its New Drug Application for Anaphylm™ (epinephrine) Sublingual Film, which is intended for treating severe allergic reactions, including anaphylaxis. This notification has precluded discussions regarding labeling and post-marketing commitments for the product [2]. Next Steps - Investors who purchased or acquired Aquestive shares and experienced losses are encouraged to contact Bragar Eagel & Squire for more information regarding their rights and potential claims. The firm offers consultations without any cost or obligation [3]. About Bragar Eagel & Squire, P.C. - Bragar Eagel & Squire, P.C. is a nationally recognized law firm with a focus on representing individual and institutional investors in various types of litigation, including securities and consumer protection cases. The firm operates nationwide and handles cases in both federal and state courts [4].