Form 8-K
8-K — BioXcel Therapeutics, Inc.
Accession: 0001104659-26-038174
Filed: 2026-04-01
Period: 2026-04-01
CIK: 0001720893
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Other Events
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
April 1, 2026
BioXcel
Therapeutics, Inc.
(Exact name of registrant as specified in its
charter)
Delaware
001-38410
82-1386754
(State
or other jurisdiction of
incorporation)
(Commission
File Number)
(I.R.S.
Employer
Identification No.)
555
Long Wharf Drive
New
Haven, CT 06511
(Address of principal executive offices, including
Zip Code)
(475)
238-6837
(Registrant’s telephone number, including
area code)
N/A
(Former name or former address, if changed
since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered
pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common
Stock, par value $0.001
BTAI
The Nasdaq
Capital Market
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01 Other Events.
On April 1, 2026, BioXcel Therapeutics, Inc. (the
“Company”) announced that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application for
the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026.
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: April 1, 2026
BIOXCEL THERAPEUTICS, INC.
/s/ Richard Steinhart
By: Richard Steinhart
Title:
Chief Financial Officer
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