UNITED STATES
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FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On December 1, 2021, BioXcel Therapeutics, Inc. (the “Company”) announced that, in connection with the U.S. Food and Drug Administration’s ongoing review of the Company’s New Drug Application (“NDA”) for its product candidate BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, the Company responded to the FDA’s an information request by the FDA pertaining to analyses of clinical data and was informed the application would require additional time for review. As a result, the previously disclosed Prescription Drug User Fee Act action date for the NDA of January 5, 2022 is now April 5, 2022.
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: December 1, 2021 | BIOXCEL THERAPEUTICS, INC. |
| /s/ Javier Rodriguez | |
| Javier Rodriguez | |
| Chief Legal Officer and Corporate Secretary |