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Monday, March 3, 2025

BioXcel: FDA Closed Inspection of Site for Phase Alzheimer’s Dementia Trial

 FDA concludes site inspection is closed under 21 C.F.R.20.64(d)(3); Voluntary Action Indicated

Company believes this further supports reliability of data from TRANQUILITY II trial of BXCL501

https://www.globenewswire.com/news-release/2025/03/03/3035455/0/en/BioXcel-Therapeutics-Announces-FDA-Closed-its-Inspection-of-Site-for-Phase-3-TRANQUILITY-II-Trial-for-Acute-Treatment-of-Agitation-Associated-with-Alzheimer-s-Dementia.html

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