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].

Core Viewpoint - The stock of Aquestive Therapeutics, Inc. (AQST) has surged approximately 43% following the announcement of a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for Anaphylm Sublingual Film, aimed at treating Type I allergic reactions [1]. Stock Performance - AQST is currently trading at $4.22, reflecting a 42.98% increase from the previous close of $2.95. The stock opened at $3.79 and reached a high of $4.39 during the trading session. Over the past year, the stock has fluctuated between $2.12 and $7.55 [2]. Future Plans - The company intends to request a Type A meeting with the FDA to discuss the most efficient path for resubmission of the application. Based on an initial review of the CRL, the company estimates that resubmission will occur in the third quarter of 2026. Additionally, the company plans to request a rapid review by the FDA [3].

Group 1 - The conference call is hosted by Aquestive Therapeutics, featuring key executives including the CEO and CFO [1] - The call includes an overview of recent business developments followed by a Q&A session with additional executives [1] - A press release was issued prior to the call, and a recording along with supplemental materials will be available on the company's website [2]

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Summary of Aquestive Therapeutics Conference Call Company Overview - **Company**: Aquestive Therapeutics (NasdaqGM:AQST) - **Industry**: Pharmaceutical, specifically focused on the development of treatments for anaphylaxis Key Points and Arguments FDA Communication and Response Letter - The FDA issued a Complete Response Letter (CRL) regarding the Anaphylm Epinephrine Sublingual Film application, indicating that additional work is required before approval [5][12] - No deficiencies were cited regarding pharmacokinetic (PK) data, repeat dose safety, or sustainability of Anaphylm's performance [5][6] - Concerns were raised about packaging, use, administration, and labeling, collectively referred to as human factors [6][7] Human Factors and Clinical Studies - The FDA's human factors group expressed concerns about the ease of opening the pouch and potential tearing of the film during administration [7][8] - In a validation study, only one participant had difficulty opening the pouch, and instances of tearing did not prevent full dosing [8][9] - Feedback indicated that the film's administration location and potential chewing by users could lead to issues, although clinical studies showed no significant problems with tolerability [9][10] Resubmission Plans - A straightforward path to resubmission is anticipated by the third quarter of the year, with a focus on conducting a human factors validation study and a pharmacokinetic study [11][12] - The company aims to work with the FDA for a rapid review and approval process post-resubmission [12] Market and Launch Strategy - The market for epinephrine treatments is primarily dominated by autoinjectors, but there is a growing demand for alternatives like Anaphylm [16][17] - Market research indicates that 96% of patients prefer Anaphylm when comparing it to other products [17][18] - Plans for international filings in Canada and Europe are underway, with a focus on establishing distribution strategies [12][72] Recruitment and Sales Strategy - Recruitment for the sales team will be revisited closer to the approval date, with prior candidates being prioritized [70][71] - The company is preparing educational materials and demo units for healthcare providers to ensure proper administration of Anaphylm [75][77] Regulatory and Clinical Development - The company has had pre-submission meetings with Canadian and European health authorities, indicating a clear path forward for regulatory submissions [87] - Ongoing development of the Adrenoverse platform and AQST-108 will continue alongside efforts for Anaphylm [88][89] Additional Important Information - The absence of safety concerns in the CRL implies that the FDA is satisfied with the safety profile of Anaphylm [38][39] - The company is committed to improving packaging and instructions based on FDA feedback to enhance user experience [63][64] - The CRL has provided clarity on the path to approval, reducing uncertainties previously associated with the product [24][25] This summary encapsulates the critical aspects of the conference call, highlighting the company's current status, challenges, and future plans in the context of regulatory approval and market strategy.

1 These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans for Anaphylm; risk of del ...

Core Viewpoint - The U.S. Food and Drug Administration has declined to approve Aquestive Therapeutics' oral drug for severe allergic reactions, indicating a setback for the company in its product development efforts [1] Company Summary - Aquestive Therapeutics has faced a significant regulatory hurdle as the FDA did not approve its oral drug intended for treating severe allergic reactions, which may impact the company's future revenue and market position [1]

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]