BioXcel Therapeutics (BTAI) files sNDA to expand IGALMI for at-home agitation treatment

Rhea-AI Filing Summary

BioXcel Therapeutics, Inc. filed a current report describing a key regulatory milestone for its drug IGALMI®. The company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking to expand IGALMI’s use to an at-home setting for the acute treatment of agitation associated with bipolar disorders or schizophrenia. IGALMI was previously approved in April 2022 as the first and only orally dissolving sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults under the supervision of a healthcare provider. The new sNDA aims to broaden IGALMI’s label to cover at-home use for a wider patient population, an area where the company notes there are currently no FDA-approved treatment options.

Insights

Biopharma regulatory and pipeline analyst

BioXcel advances IGALMI with an sNDA for at-home use, but approval and impact remain pending.

BioXcel Therapeutics is seeking to expand IGALMI® beyond supervised healthcare settings by submitting a supplemental New Drug Application to the FDA for at-home use in the acute treatment of agitation in bipolar disorders and schizophrenia. This builds on IGALMI’s existing approval in April 2022 as an orally dissolving sublingual film used under healthcare provider supervision.

If approved, the expanded label would target a broader at-home patient population where the company states there are currently no FDA-approved options, potentially increasing IGALMI’s addressable market. However, the filing does not describe review timing, study details, or potential market size, so the eventual commercial effect will depend on the FDA’s decision and future implementation specifics.

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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): January 20, 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 January 20, 2026, BioXcel Therapeutics, Inc. (the “Company”) announced the submission on January 14, 2026 of a supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) for IGALMI® in the at-home use setting for the acute treatment of agitation associated with bipolar disorders or schizophrenia. In April 2022, IGALMI was approved by the FDA as the first and only orally dissolving sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults under the supervision of a healthcare provider. This sNDA submission seeks to expand IGALMI’s label to include the broader at home patient population where there are no FDA-approved options currently available.

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: January 20, 2026	BIOXCEL THERAPEUTICS, INC.
		/s/ Richard Steinhart
	By:	Richard Steinhart
	Title:	Chief Financial Officer

FAQ

What did BioXcel Therapeutics (BTAI) disclose in this 8-K?

BioXcel Therapeutics reported that it submitted a supplemental New Drug Application (sNDA) to the U.S. FDA to expand IGALMI® for at-home use in treating acute agitation associated with bipolar disorders or schizophrenia.

What is IGALMI and what is it currently approved for?

IGALMI is an orally dissolving sublingual film that was approved by the FDA in April 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults under the supervision of a healthcare provider.

What label expansion is BioXcel seeking for IGALMI in the new sNDA?

The sNDA seeks to expand IGALMI’s label to include at-home use for the acute treatment of agitation associated with bipolar disorders or schizophrenia in a broader patient population.

Why is the at-home use setting for IGALMI significant for BioXcel Therapeutics?

The company states that in the at-home setting for acute agitation associated with bipolar disorders or schizophrenia there are currently no FDA-approved options, so an expanded label could open access to a new treatment setting.

Is the FDA approval for IGALMI’s at-home use already granted?

No. BioXcel Therapeutics has submitted a supplemental New Drug Application for at-home use; the filing describes the submission, not an FDA decision.

Does this 8-K discuss financial results or revenue from IGALMI?

No. The disclosure focuses on the regulatory submission for an IGALMI label expansion and does not provide financial results or revenue figures.