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Aquestive Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-05 21:01
Core Insights - Aquestive Therapeutics is progressing towards the potential launch of Anaphylm, an innovative sublingual film for treating severe allergic reactions, with a scheduled PDUFA goal date of January 31, 2026 [2][4] - The company is expanding its commercial readiness and regulatory discussions in the U.S., Canada, and the EU, aiming to enhance patient access to epinephrine treatments [5][6] - Financial results for Q3 2025 show a 4% year-over-year revenue increase, although total revenues decreased from $13.5 million in Q3 2024 to $12.8 million in Q3 2025 due to prior year deferred revenue recognition [13][17] Financial Performance - Total revenues for Q3 2025 were $12.8 million, a decrease from $13.5 million in Q3 2024, primarily due to the one-time recognition of deferred revenue in the previous year [13] - Manufacture and supply revenue increased to $11.5 million in Q3 2025 from $10.7 million in Q3 2024, driven by growth in Sympazan and Suboxone revenues [14] - Net loss for Q3 2025 was $15.4 million, or $0.14 per share, compared to a net loss of $11.5 million, or $0.13 per share, in Q3 2024 [17] Product Development - Anaphylm, if approved, would be the first oral medication for severe allergic reactions, designed to improve patient compliance and accessibility [3][22] - The company is also advancing AQST-108, a topical epinephrine gel for alopecia areata, with an IND application expected to be submitted in Q4 2025 [7][24] - Recent patent expansions for Anaphylm extend protection into 2037, highlighting the product's long-term commercial potential [6] Strategic Initiatives - The company is enhancing its commercial and medical infrastructure in preparation for a potential U.S. launch of Anaphylm in Q1 2026 [5] - Strategic funding commitments and equity financing have positioned the company to support its mission of making epinephrine treatments more accessible [2] - The addition of new leadership for the AdrenaVerse clinical pipeline indicates a commitment to developing further products from this technology platform [8]
Aquestive Therapeutics Announces Leadership Expansion to Support Growth
Globenewswire· 2025-11-04 12:00
Core Viewpoint - Aquestive Therapeutics is making strategic leadership changes to support the potential launch of Anaphylm™, a novel epinephrine product, and to enhance its development pipeline [1][2][4] Leadership Changes - Dr. Matthew Davis has been appointed as Chief Development Officer, bringing over 20 years of experience in drug development and medical leadership [2][3] - Dr. Gary Slatko returns as interim Chief Medical Officer, with over three decades of experience in regulatory science and drug safety [3] - Peter Boyd has been promoted to Chief People Officer, having led various functions within the company since 2013 [4][5] Product Development - Anaphylm™ (dibutepinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug candidate designed for the rescue treatment of severe allergic reactions [7] - If approved by the FDA, Anaphylm would be the first oral medication for anaphylaxis, with a unique delivery method that does not require water or swallowing [7] Company Overview - Aquestive Therapeutics focuses on advancing medicines through innovative science and delivery technologies, with a portfolio that includes four commercialized products [8] - The company collaborates with pharmaceutical firms to develop new molecules using proprietary technologies like PharmFilm® [8]
Aquestive Therapeutics to Participate in a Fireside Chat Hosted by Piper Sandler
Globenewswire· 2025-11-03 12:00
Core Insights - Aquestive Therapeutics, Inc. is hosting a live fireside chat on November 6, 2025, focusing on its product candidate Anaphylm™ (dibutepinephrine) Sublingual Film, discussing regulatory progress and commercial readiness [1][2] Company Overview - Aquestive Therapeutics is a pharmaceutical company dedicated to improving patients' lives through innovative science and delivery technologies, developing orally administered products to deliver complex molecules [5] - The company has four commercialized products marketed by its licensees globally and collaborates with pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm® [5] Product Details - Anaphylm™ (dibutepinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug that is designed to be administered without water or swallowing, making it user-friendly [4] - If approved by the FDA, Anaphylm would be the first oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis, with its trade name conditionally approved [4]
Aquestive Therapeutics to Attend 2025 ACAAI Annual Meeting
Globenewswire· 2025-10-30 11:00
Core Insights - Aquestive Therapeutics is advancing its product candidate Anaphylm™ (dibutepinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis, with multiple presentations scheduled at the 2025 ACAAI Annual Meeting [1][2] Company Overview - Aquestive Therapeutics focuses on innovative science and delivery technologies to improve patient lives through the development of orally administered products [4] - The company has four commercialized products and collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm® [4] Product Details - Anaphylm™ is a polymer matrix-based epinephrine prodrug that is small, lightweight, and dissolves on contact without the need for water or swallowing [3] - If approved by the FDA, Anaphylm would be the first oral medication for the rescue treatment of severe allergic reactions, with its trade name conditionally approved [3]
Aquestive Therapeutics to Report Third Quarter 2025 Financial Results and Recent Business Highlights on November 5 and Host Conference Call on November 6 at 8:00 a.m. ET
Globenewswire· 2025-10-27 11:00
Core Insights - Aquestive Therapeutics, Inc. will report its third quarter results for the period ending September 30, 2025, and provide business updates on November 5, 2025 [1] - A conference call for investors is scheduled for November 6, 2025, at 8:00 a.m. ET, with a live webcast available on the company's website [2] Company Overview - Aquestive is a pharmaceutical company focused on advancing medicines through innovative science and delivery technologies, aiming to improve patients' lives [3] - The company has four commercialized products marketed by its licensees globally and is the exclusive manufacturer of these products [3] - Aquestive is developing a late-stage proprietary product candidate for severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel for dermatological conditions like alopecia areata [3]
Are Medical Stocks Lagging Aquestive Therapeutics (AQST) This Year?
ZACKS· 2025-10-15 14:41
Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Is Aquestive Therapeutics (AQST) one of those stocks right now? Let's take a closer look at the stock's year-to-date performance to find out.Aquestive Therapeutics is a member of the Medical sector. This group includes 956 individual stocks and currently holds a Zacks Sector Rank of #3. The Zacks Sector Rank considers 16 different groups, measuring the average Zacks Rank of the individual stoc ...
Aquestive Therapeutics Stock: A Measured Bet (NASDAQ:AQST)
Seeking Alpha· 2025-10-12 06:57
Core Insights - The article emphasizes the importance of applying personal knowledge and experience in stock picking to achieve better investment outcomes [1] Group 1: Investment Philosophy - The author advocates for value investing and highlights the potential for educated individuals to outperform the market by understanding basic accounting and financial principles [1] - The focus is on identifying reasonably priced companies with steady long-term growth prospects, as well as small- and mid-cap companies with exponential growth potential [1] Group 2: Professional Background - The author has a background as a corporate lawyer with an MBA and has spent 7 years in prestigious law firms before founding a boutique law firm specializing in investment transactions and dispute resolution [1]
Aquestive Therapeutics: A Measured Bet
Seeking Alpha· 2025-10-12 06:57
Core Insights - The article emphasizes the importance of applying personal knowledge and experience in stock picking to achieve better investment outcomes [1] - The author has a background in corporate law and investment transactions, focusing on identifying reasonably priced companies with long-term growth potential and small- to mid-cap companies with exponential growth opportunities [1] Group 1: Investment Philosophy - The belief that educated individuals can outperform the market if they understand basic accounting and financial principles [1] - The approach involves careful fundamental analysis of businesses, financials, and valuations to identify investment opportunities [1] Group 2: Professional Background - The author has 10 years of experience running a boutique law firm specializing in investment transactions and dispute resolution after 7 years in prestigious law firms [1]
Aquestive Therapeutics (AQST) Surges 7.9%: Is This an Indication of Further Gains?
ZACKS· 2025-10-10 14:01
Core Insights - Aquestive Therapeutics (AQST) shares increased by 7.9% to $6.69, with a notable trading volume, contributing to a 27.1% gain over the past four weeks [1][2] Company Overview - The rise in stock price is attributed to positive expectations for Anaphylm, a key product candidate under FDA review for severe allergic reactions [2] - The USPTO granted two additional patents for Anaphylm, extending its protection until 2037 [2] Financial Performance - The company is projected to report a quarterly loss of $0.13 per share, unchanged from the previous year, with expected revenues of $13.36 million, a decrease of 1.3% year-over-year [3] - The consensus EPS estimate has remained stable over the last 30 days, indicating that stock price movements may not sustain without earnings estimate revisions [4] Industry Context - Aquestive Therapeutics holds a Zacks Rank of 3 (Hold), indicating a neutral outlook within the Zacks Medical - Drugs industry [5] - Comparatively, Madrigal (MDGL), another company in the same industry, experienced a 2% decline in its stock price, with a 1.6% return over the past month [5]
Aquestive gains after patent wins for Anaphylm (AQST:NASDAQ)
Seeking Alpha· 2025-10-08 16:43
Core Viewpoint - Shares of Aquestive Therapeutics rose following the announcement of two new patents for its allergy therapy Anaphylm, which is currently under FDA review [4]. Company Summary - Aquestive Therapeutics is based in Warren, New Jersey, and operates in the biopharmaceutical sector [4]. - The newly issued patents cover the company's allergy therapy, Anaphylm, indicating potential for enhanced market position and intellectual property protection [4].