What's Going On With Aquestive Therapeutics Stock After FDA Update For Lead Allergic Treatment?

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].