Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Significant Losses In Aquestive Therapeutics To Contact Him Directly To Discuss Their Options If you suffered significant losses in Aquestive Therapeutics stock or options and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, Feb. 15, 2026 (GLOBE NEWSWIRE) ...

Core Viewpoint - Aquestive Therapeutics, Inc. experienced a significant stock decline of approximately 40% after the FDA identified deficiencies in its New Drug Application for Anaphylm, raising concerns about the drug's approvability ahead of the January 31, 2026 PDUFA action date [4]. Company Overview - Aquestive Therapeutics, Inc. is a biopharmaceutical company focused on developing innovative therapies for patients with severe allergic reactions, including anaphylaxis [4]. Legal Investigation - Faruqi & Faruqi, LLP, a national securities law firm, is investigating potential claims against Aquestive Therapeutics for investors who suffered significant losses due to the recent stock decline [2][3].

Core Viewpoint - Aquestive Therapeutics, Inc. experienced a significant stock decline of approximately 40% following the FDA's identification of deficiencies in its New Drug Application for Anaphylm, raising concerns about the drug's approvability ahead of the upcoming PDUFA action date on January 31, 2026 [3]. Company Summary - Faruqi & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics due to the recent stock losses [2]. - The firm has a history of recovering hundreds of millions of dollars for investors since its establishment in 1995 [2]. Industry Context - The FDA's feedback on the New Drug Application for Anaphylm indicates significant regulatory hurdles that could impact the company's future product approvals and market performance [3].

Core Viewpoint - Lake Street has lowered the price target for Aquestive Therapeutics (AQST) to $6 from $8 while maintaining a Buy rating after the company received a Complete Response Letter (CRL) for Anaphylm and plans to resubmit in Q3 [1] Group 1 - The price target adjustment reflects the delay in the approval of Anaphylm [1] - Revenue estimates have been adjusted accordingly due to the CRL received by the company [1]

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving Aquestive Therapeutics, Inc. and its officers and directors [1]. Group 1: Company Overview - Aquestive Therapeutics, Inc. is currently facing scrutiny regarding its New Drug Application (NDA) for Anaphylm, as the FDA has identified deficiencies that prevent further discussions on labeling and post-marketing commitments [3]. - Following the announcement of the FDA's findings, Aquestive's stock price experienced a significant decline, falling by $2.30 per share, or 37.04%, closing at $3.91 per share on January 9, 2026 [3]. Group 2: Legal Investigation - Pomerantz LLP, a prominent law firm specializing in corporate and securities class litigation, is leading the investigation into the claims against Aquestive [1][4]. - The firm has a long history of advocating for victims of securities fraud and has successfully recovered multimillion-dollar damages for class members [4].

Core Viewpoint - Aquestive Therapeutics (AQST) received a Complete Response Letter (CRL) for Anaphylm, but the outcome is seen as recoverable with a clear path to approval [1] Group 1: FDA Response - The FDA's prior deficiency letter was anticipated by Leerink analyst Roanna Ruiz, indicating that the CRL was not unexpected [1] - No additional studies beyond those already conducted have been requested by the FDA, which is a positive sign [1] Group 2: Market Reaction - Following the news, shares of AQST increased by over 45%, reaching $4.29 in morning trading [1] Group 3: Future Considerations - The CRL does not raise concerns regarding comparability data or Chemistry, Manufacturing, and Controls (CMC), suggesting manageable studies for resubmission [1] - Potential risks include delays in Anaphylm's U.S. launch and reliance on favorable results from HF testing and PK studies for resubmission [1]

Company Overview - Aquestive Therapeutics, Inc. (NASDAQ:AQST) is a pharmaceutical company focused on developing and commercializing innovative products to address unmet medical needs, specializing in oral film-based drug delivery systems [2][4] - Competitors include Teva Pharmaceuticals and Viatris, which also focus on drug delivery technologies [2] Recent Developments - New Street set a price target of $12 for AQST, indicating a potential upside of approximately 193% from its trading price of $4.10 [3] - Despite receiving a Complete Response Letter (CRL) from the FDA for Anaphylm, AQST's stock has increased by 38.98%, rising by $1.15 [3][4] - The CRL highlighted deficiencies in the human factors validation study, temporarily halting discussions on labeling and post-marketing commitments [4] - AQST's stock has shown volatility, with a daily trading range between $3.79 and $4.39, and has fluctuated between a high of $7.55 and a low of $2.12 over the past year [4] Market Position - AQST's market capitalization stands at approximately $500.21 million, with a trading volume of 60.81 million shares on the NASDAQ exchange [4] - The outcome of discussions to address the FDA's concerns regarding Anaphylm is crucial for the company's future, as it represents a significant opportunity in the treatment of anaphylaxis [5]

Core Viewpoint - The Schall Law Firm is investigating claims against Aquestive Therapeutics, Inc. for potential violations of securities laws related to misleading statements and undisclosed information affecting investors [1][2]. Group 1: Investigation Details - The investigation centers on whether Aquestive issued false or misleading statements and failed to disclose critical information to investors [2]. - On January 9, 2026, Aquestive announced that the FDA identified deficiencies in its New Drug Application (NDA) for Anaphylm, which prevented discussions on labeling and post-marketing commitments [2]. - Following this announcement, shares of Aquestive dropped by over 37% on the same day [2]. Group 2: Legal Representation - The Schall Law Firm encourages shareholders who suffered losses to participate in the investigation and offers free consultations regarding their rights [3]. - The firm specializes in securities class action lawsuits and shareholder rights litigation, representing investors globally [3].

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]