Aquestive Stock Slides After FDA Flags Issues With Allergy Drug Application
AQST's significant drop indicates investor concern over FDA's NDA issues, similar to past FDA rejections causing stock declines.
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AQST's significant drop indicates investor concern over FDA's NDA issues, similar to past FDA rejections causing stock declines.
What happened, with direct paths to the underlying reporting
AQST stock dropped 40.18% after FDA's notification of NDA deficiencies. FDA did not specify deficiencies but ongoing review is crucial. Aquestive plans to respond to FDA before January 31, 2026 deadline. Company has $120 million cash for Anaphylm approval process. ARS Pharmaceuticals urged FDA to delay AQST’s epinephrine approval.
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