Changes strategically aligned to support planned launch of Anaphylm™ (dibutepinephrine) Sublingual Film, if approved by the FDA, and to accelerate the Company’s ongoing development initiatives Matthew Davis, M.D., RPh will join immediately as Chief Development OfficerGary Slatko, M.D., M.B.A, will become interim Chief Medical Officer Peter Boyd, M.B.A, has been promoted to Chief People Officer WARREN, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Co ...

WARREN, N.J., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that David Amsellem, Sr. Research Analyst at Piper Sandler, will host a live fireside chat with the Company’s management team on November 6, 2025 at 12:00 p.m. ET. The discussion will focus on the Company’s product candida ...

WARREN, N.J., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that multiple presentations highlighting results from the investigational use of its product candidate Anaphylm™ (dibutepinephrine) sublingual film in the treatment of severe allergic reactions, including anaphylaxis, will ...

New patents extend protection for Anaphylm™ into 2037Anaphylm (dibutepinephrine) Sublingual Film, if approved by the FDA, will be the first and only oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis WARREN, N.J., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologi ...

核心观点 - 美国食品药品监督管理局(FDA)已通知公司无需为Anaphylm™(地布肾上腺素)舌下膜举行咨询委员会会议 其处方药用户费用法案(PDUFA)目标行动日期仍为2026年1月31日[1] - Anaphylm有望成为首个且唯一获得FDA批准的非侵入性口服肾上腺素产品 用于治疗严重过敏反应包括过敏症[2] - 公司近期完成1.6亿美元融资活动 为产品获批后的市场推广提供资金支持[3] 产品特性 - Anaphylm采用邮票大小的可溶解薄膜设计 无需设备或针头 通过舌下给药方式发挥作用[2][4] - 产品包装薄于标准信用卡 可随身携带 并具备防雨防日光等耐候特性[4] - 已完成11项临床研究 共967次给药(840次单剂量和127次重复剂量) 覆盖30公斤以上儿童及成人群体[3] 临床进展 - 开发项目包含针对口腔过敏综合征的创新试验 证明Anaphylm在实际使用场景中的有效性[3] - 新药申请(NDA)按计划推进 符合FDA规定的2026年1月31日PDUFA目标日期[7] - 商业化准备工作持续进行 确保获批后快速启动市场投放[7] 公司背景 - 公司专注于通过创新科技和给药技术开发口服药物 提供针对复杂分子的口服给药方案[5] - 拥有4个已商业化产品 由被许可方在美国及全球市场销售 并作为这些许可产品的独家生产商[5] - 除Anaphylm外 公司还推进早期阶段肾上腺素前药局部凝胶产品AQST-108 用于潜在皮肤病治疗[8]