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BioXcel Therapeutics Announces TRANQUILITY In-Care Pivotal Phase 3 Trial Plan With BXCL501 for Agitation Associated With Alzheimer’s Dementia

BioXcel Therapeutics, Inc. (BTAI) 
Last bioxcel therapeutics, inc. earnings: 11/14 07:00 am Check Earnings Report
Company Research Source: GlobeNewswire
Company plans to initiate trial following recent meeting with FDA No FDA-approved therapies for acute treatment of AAD are currently available NEW HAVEN, Conn., April 10, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced details regarding the planned design of its upcoming TRANQUILITY In-Care Phase 3 trial to evaluate BXCL501, the company’s investigational proprietary, orally dissolving film formulation of dexmedetomidine, as a potential acute treatment for agitation associated with Alzheimer’s dementia (AAD) in the care setting. The Company’s plan to conduct this trial is based on feedback received from the U.S. Food and Drug Administration (FDA), following the recent receipt of minutes from the Type B/Breakthrough Therapy designation meeting held with the agency on February 20, 2024. “The design of our upcoming Show less Read more
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