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 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 is publicly traded on NASDAQ under the ticker symbol AQST [4]. Group 2: Recent Developments - The FDA has identified deficiencies in the New Drug Application for Anaphylm, which is an experimental sublingual film intended for the treatment of severe allergic reactions, including anaphylaxis [5]. - The deficiencies noted by the FDA currently prevent discussions regarding labeling and post-marketing requirements, which raises concerns about the likelihood of the application being approved by the January 31, 2026 PDUFA action date [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].

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 - Aquestive Therapeutics, Inc. is focused on developing innovative oral film-based drug delivery systems to meet unmet medical needs, despite facing regulatory challenges with its Anaphylm product [1][2]. Group 1: Company Overview - Aquestive Therapeutics specializes in oral film-based drug delivery systems [1]. - The company has maintained a stable financial position, expecting substantial cash reserves by the end of the year [3]. Group 2: Regulatory Developments - Recently, the FDA issued a Complete Response Letter (CRL) for the Anaphylm Epinephrine Sublingual Film, citing deficiencies in packaging and administration [2]. - The company plans to address the FDA's concerns and resubmit the application by the third quarter of 2026 [3]. Group 3: Market Performance - The current stock price for AQST is $4.18, reflecting a significant increase of 41.69% with a change of $1.23 [4]. - Over the past year, AQST's stock has fluctuated between a high of $7.55 and a low of $2.12, with a market capitalization of approximately $415.1 million [4].

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 - Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for Anaphylm, indicating deficiencies primarily related to human factors and labeling [1][2]. Group 1: FDA Response and Concerns - The FDA's CRL highlighted issues with the human factors validation study, including difficulties in opening the pouch and incorrect film placement, which could pose safety risks during anaphylaxis [2][3]. - The FDA's concerns are limited to human factors and a supportive pharmacokinetics (PK) study, with no additional studies requested [5]. Group 2: Company Actions and Future Plans - To address the FDA's concerns, the company has modified the pouch opening and labeling, and plans to conduct a new human factors validation study [4]. - The company estimates resubmission of the NDA in early Q3 2026, contingent on completing the necessary studies and typical FDA response times [6]. - Additionally, the company plans to submit a marketing authorization application in Europe and a New Drug Submission in Canada in the second half of 2026 [7]. Group 3: Market Reaction and Analyst Expectations - Following the news, Aquestive Therapeutics shares increased by 45.25% to $4.28 [8]. - Analyst expectations suggest that Anaphylm's approval decision may occur in the first half of 2027 [8].