Core Insights - Holzer & Holzer, LLC is investigating whether Aquestive Therapeutics, Inc. complied with federal securities laws following the FDA's notice regarding deficiencies in the New Drug Application for Anaphylm™ [1] - The FDA's notice indicates that the identified deficiencies preclude discussion of labeling and post-marketing commitments for Anaphylm™, which is intended for treating severe allergic reactions [1] - Following the FDA's announcement, the stock price of Aquestive Therapeutics experienced a decline [1] Company Information - Aquestive Therapeutics, Inc. is focused on developing treatments for severe allergic reactions, including anaphylaxis, through its product candidate Anaphylm™ [1] - Holzer & Holzer, LLC is a law firm that specializes in representing shareholders and investors in securities litigation, including class action and derivative litigation [3] - The firm has a history of recovering hundreds of millions of dollars for shareholders affected by corporate misconduct since its founding in 2000 [3]

Group 1 - ARS Pharmaceuticals Inc. stock increased by 18.86% to $13.01 following a negative update regarding its competitor, Aquestive Therapeutics Inc. [5] - The FDA identified deficiencies in Aquestive's Anaphylm's New Drug Application, which delays discussions on labeling and post-marketing commitments [1] - This situation allows ARS Pharmaceuticals to establish its needle-free epinephrine device, neffy, as the only option in the market for the time being [2] Group 2 - ARS Pharmaceuticals filed a petition urging the FDA to delay approval of Aquestive's AQST-109, citing safety and efficacy concerns [3] - The company argues that current data do not sufficiently demonstrate the drug's safety or efficacy for anaphylaxis patients and requests additional studies [4] - Analysts see significant potential for neffy and believe the company is well-funded to support its launch [4]

Market Performance - U.S. stocks showed positive movement, with the Nasdaq Composite gaining approximately 150 points on Friday [1] - The Dow increased by 0.38% to 49,453.05, while the NASDAQ rose by 0.66% to 23,635.11, and the S&P 500 climbed 0.48% to 6,954.85 [1] - European shares also experienced gains, with the eurozone's STOXX 600 up by 0.91% and other major indices like Spain's IBEX 35 and London's FTSE 100 also rising [6] - Asian markets closed mostly higher, with Japan's Nikkei 225 gaining 1.61% and China's Shanghai Composite rising 0.92% [7] Sector Performance - Utilities sector shares increased by 1.5% on Friday, while health care stocks saw a decline of 0.5% [1] Commodity Prices - Oil prices rose by 2.7% to $59.34, gold increased by 1.2% to $4,514.50, silver surged by 6.3% to $79.895, and copper rose by 2% to $5.9150 [5] Company News - Rich Sparkle Holdings Ltd shares surged 115% to $52.00 after signing a $39 million offering of 3 million ordinary shares at $13 per share [9] - Quanterix Corp shares increased by 31% to $8.54 following the appointment of a new CEO [9] - CG Oncology Inc shares rose by 24% to $52.18 after announcing an expedited timeline for clinical trial data [9] - Aquestive Therapeutics Inc shares dropped 40% to $3.72 due to FDA identified deficiencies [9] - Pacira Biosciences Inc shares fell 13% to $22.70 after reporting preliminary FY25 revenue results [9] - Beta Bionics Inc shares decreased by 31% to $21.98 following preliminary fourth-quarter financial results [9] Economic Indicators - Nonfarm payrolls increased by 50,000 in December, slightly below expectations [10] - The unemployment rate decreased to 4.4%, below expectations of 4.5% [10] - Average hourly earnings rose by 0.3%, matching forecasts [10] - Housing starts declined by 4.6% to an annualized rate of 1.246 million units [10] - Building permits fell by 0.2% to an annualized rate of 1.412 million [10] - The University of Michigan's consumer sentiment index rose to 54.0, the highest since September 2025 [2][10]

Market Performance - U.S. stocks showed positive movement, with the Nasdaq Composite gaining approximately 150 points on Friday [1] - The Dow increased by 0.38% to 49,453.05, while the NASDAQ rose by 0.66% to 23,635.11, and the S&P 500 climbed 0.48% to 6,954.85 [1] - Utilities sector shares increased by 1.5%, while health care stocks experienced a decline of 0.5% [1] Commodity Prices - Oil prices rose by 2.7% to $59.34, gold increased by 1.2% to $4,514.50, silver surged by 6.3% to $79.895, and copper rose by 2% to $5.9150 [5] European Market Trends - European shares were generally higher, with the eurozone's STOXX 600 gaining 0.91%, Spain's IBEX 35 Index rising 0.01%, London's FTSE 100 increasing by 0.85%, Germany's DAX up by 0.43%, and France's CAC 40 rising by 1.23% [6] Asian Market Trends - Asian markets closed mostly higher, with Japan's Nikkei 225 gaining 1.61%, Hong Kong's Hang Seng Index up by 0.32%, China's Shanghai Composite rising by 0.92%, while India's BSE Sensex fell by 0.72% [7] Company-Specific Movements - Rich Sparkle Holdings Ltd saw its shares increase by 115% to $52.00 after signing a $39 million offering of 3 million ordinary shares at $13 per share [9] - Quanterix Corp shares surged by 31% to $8.54 following the appointment of Everett Cunningham as President and CEO [9] - CG Oncology Inc shares rose by 24% to $52.18 after announcing an expedited timeline for clinical trial data [9] - Aquestive Therapeutics Inc shares dropped by 40% to $3.72 due to an FDA letter identifying deficiencies [9] - Pacira Biosciences Inc shares fell by 13% to $22.70 after reporting preliminary FY25 revenue results [9] - Beta Bionics Inc shares decreased by 31% to $21.98 following preliminary fourth-quarter financial results [9] Economic Indicators - Nonfarm payrolls increased by 50,000 in December, slightly below expectations of 60,000 [10] - The unemployment rate decreased from 4.5% in November to 4.4%, below expectations [10] - Average hourly earnings rose by 0.3%, matching forecasts [10] - Housing starts declined by 4.6% to an annualized rate of 1.246 million units, while building permits fell by 0.2% to an annualized rate of 1.412 million [10] - The University of Michigan's consumer sentiment index rose to 54.0 in January, the highest since September 2025 [10]

Core Viewpoint - Aquestive Therapeutics, Inc. is facing significant challenges following the FDA's identification of deficiencies in its New Drug Application for Anaphylm, leading to a sharp decline in its stock price by approximately 40% [2]. Group 1: Company Overview - Aquestive Therapeutics, Inc. is a biopharmaceutical company focused on developing innovative treatments for severe allergic reactions, including anaphylaxis [2]. Group 2: Regulatory Challenges - The FDA has identified deficiencies in the New Drug Application (NDA) for Anaphylm, which is a sublingual film intended for treating severe allergic reactions [2]. - These deficiencies currently prevent discussions regarding labeling and post-marketing requirements, raising concerns about the application's approvability ahead of the January 31, 2026, PDUFA action date [2]. Group 3: Market Reaction - Following the FDA's announcement, shares of Aquestive Therapeutics, Inc. experienced a significant intraday drop of approximately 40% [2].

Core Viewpoint - Aquestive Therapeutics Inc. is experiencing a decline in stock price due to identified deficiencies in the New Drug Application for Anaphylm, which is a polymer matrix-based epinephrine prodrug product candidate aimed at treating severe allergic reactions, including anaphylaxis [2][3][6] Group 1: Stock Performance - The stock of Aquestive Therapeutics is trading lower, with a session volume of 5.68 million compared to the average volume of 2.79 million [1] - At the time of publication, shares were down 40.18% at $3.71 [6] Group 2: FDA Review and Deficiencies - The FDA has identified deficiencies in Anaphylm's New Drug Application that prevent discussions on labeling and post-marketing commitments [2] - The specific deficiencies have not been disclosed, but the company is actively working to understand and resolve these concerns [2][4] - The FDA's review of the application remains ongoing, and a Discipline Review Letter will not be issued, although information requests may occur during the review period [4] Group 3: Product Details and Future Plans - Anaphylm is designed to be a sublingual film that is similar in size to a postage stamp and begins to dissolve on contact, requiring no water or swallowing for administration [3] - The company plans to submit for regulatory approval of Anaphylm in Canada, Europe, and the U.K. by 2026 [3] Group 4: Financial Position and Future Outlook - As of the end of 2025, the company had approximately $120 million in cash and cash equivalents, which is believed to be sufficient for completing the Anaphylm approval and launch processes in the U.S. if approved [5] - Delays in communicating specific deficiencies may lead to further delays in the potential approval of Anaphylm [5]

Core Viewpoint - Block & Leviton is investigating Aquestive Therapeutics, Inc. for potential securities law violations following a significant drop in the company's stock price due to FDA deficiencies in its new drug application for Anaphylm [1][2]. Group 1: Company Overview - Shares of Aquestive Therapeutics fell more than 40% on January 9, 2026, after the company disclosed that the FDA identified deficiencies in its new drug application for Anaphylm, raising the risk of delayed approval [2]. - Block & Leviton is investigating the company's prior disclosures to determine if there were any securities law violations [4]. Group 2: Investor Information - Any investor who purchased Aquestive Therapeutics common stock and has experienced a decline in their investment may be eligible to recover losses, regardless of whether they have sold their shares [3]. - Investors are encouraged to contact Block & Leviton for more information on how to proceed with potential recovery [5]. Group 3: Legal Action and Whistleblower Information - Block & Leviton may file an action to recover losses on behalf of investors who have lost money due to the company's disclosures [4]. - Whistleblowers with non-public information about Aquestive Therapeutics are encouraged to assist in the investigation or report to the SEC, with potential rewards of up to 30% of any successful recovery [6]. Group 4: Firm Reputation - Block & Leviton is recognized as a leading securities class action firm, having recovered billions of dollars for defrauded investors and representing many top institutional investors [7].

Core Viewpoint - Aquestive Therapeutics is facing regulatory challenges with the FDA regarding its New Drug Application (NDA) for Anaphylm™, which has identified deficiencies that prevent discussions on labeling and post-marketing commitments, although the review is ongoing and no final decision has been made [2][6]. Regulatory Approval Status - The FDA has notified Aquestive of deficiencies in the NDA for Anaphylm, which the company is working to understand and resolve before the scheduled PDUFA action date of January 31, 2026 [2][3]. - The NDA submission for Anaphylm is supported by a comprehensive clinical development program, including eleven independent clinical studies with approximately 967 total administrations across 411 subjects [3]. Global Expansion Plans - Aquestive is advancing its global expansion strategy for Anaphylm, with plans to submit regulatory approvals in Canada, Europe, and the United Kingdom in 2026 [4][5]. - The company expects to submit its New Drug Submission (NDS) to Health Canada in the first half of 2026 and has received positive feedback from the European Medicines Agency (EMA) indicating no further clinical trials are needed prior to submission [4]. Financial Position - As of December 31, 2025, the company reported approximately $120 million in cash and cash equivalents, which is believed to be sufficient to support the approval and launch processes for Anaphylm in the U.S. and other key markets [6][7]. Product Overview - Anaphylm™ (dibutepinephrine) is a sublingual film designed to be easy-to-use, fast-acting, and portable, representing a significant advancement for individuals with severe allergies [2][8]. - The product is comparable in pharmacokinetic profile to leading epinephrine auto-injectors and has shown a safety profile similar to that of epinephrine [3].

Core Insights - The article discusses the potential approval of Anaphylm by Aquestive Therapeutics (AQST) and highlights possible catalysts leading up to the FDA PDUFA date [1]. Group 1: Company Overview - Aquestive Therapeutics is focused on developing innovative therapies and pharmaceuticals, particularly in the biotech sector [1]. - The company has a beneficial long position in its shares, indicating confidence in its future performance [2]. Group 2: Investment Strategy - The investment strategy revolves around identifying breakthrough therapies and potential acquisition targets within the healthcare sector [1]. - The investing group, Compounding Healthcare, offers various resources including model healthcare portfolios, newsletters, and a daily watchlist to support investors [1].

Group 1 - The article discusses the potential approval of Anaphylm by Aquestive Therapeutics (AQST) and highlights possible catalysts leading up to the FDA PDUFA date [1] - The author emphasizes a focus on innovative companies in the biotech sector that are developing breakthrough therapies and pharmaceuticals [1] - The investing group, Compounding Healthcare, offers features such as model healthcare portfolios, a weekly newsletter, and a daily watchlist for investors [1] Group 2 - The author has a beneficial long position in AQST shares, indicating a personal investment interest in the company [2] - The article expresses the author's opinions without any compensation from companies mentioned, ensuring an independent viewpoint [2] - Seeking Alpha clarifies that past performance does not guarantee future results and that the views expressed may not reflect the platform's overall stance [3]