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Item 8.01. | Other Events. |
On September 5, 2024, BioXcel Therapeutics, Inc. (the “Company”) submitted to the U.S. Food and Drug Administration (FDA) the Company’s proposed protocol for its TRANQUILITY In-Care pivotal Phase 3 trial designed to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for agitation associated with Alzheimer’s dementia.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: September 9, 2024 | BIOXCEL THERAPEUTICS, INC. |
/s/ Javier Rodriguez | |
Javier Rodriguez | |
SVP, Chief Legal Officer |