Oral film-based drug delivery systems
Search documents
Aquestive Therapeutics, Inc. (NASDAQ:AQST) Maintains "Outperform" Rating Amid FDA Setback
Financial Modeling Prep· 2026-02-02 21:04
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].