Item 7.01 Regulation FD Disclosure.
On January 28, 2021, BioXcel Therapeutics, Inc. (the "Company") announced that
it had received notice that the U.S. Food and Drug Administration ("FDA") has
granted orphan drug designation for the Company's product candidate, BXCL701,
previously studied as Talabostat, for the treatment of soft tissue sarcoma.
Under the Orphan Drug Act, the FDA may grant orphan drug designation upon
request by a sponsor to a drug intended to treat a rare disease or condition,
which is generally a disease or condition that affects fewer than 200,000
individuals in the United States. Orphan drug designation, however, does not
convey any advantage in or shorten the duration of the regulatory review and
approval process. Once granted, orphan drug designation qualifies the sponsor
for various incentives, including potential tax credits, a reduction in certain
regulatory fees, and eligibility for a seven-year exclusive marketing period for
that drug and use upon marketing approval.
The information in this Current Report on Form 8-K shall not be deemed "filed"
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the "Exchange Act"), or otherwise subject to the liabilities of that Section,
nor shall it be deemed to be incorporated by reference into any filing of the
Company under the Securities Act of 1933, as amended, or the Exchange Act,
except as expressly set forth by specific reference in such filing.
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BIOXCEL THERAPEUTICS, INC. 
