[8-K] BioXcel Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

BioXcel Therapeutics (BTAI) updated its regulatory timeline, stating it now expects to complete submission of a supplemental New Drug Application (sNDA) for an IGALMI® label expansion early in the first quarter of 2026.

The filing highlights two recently completed studies that will anchor the sNDA package: the SERENITY At-Home pivotal Phase 3 safety trial for agitation associated with bipolar disorders or schizophrenia, which delivered positive topline safety and exploratory efficacy data in August 2025, and an October 2025 correlation study that also reported positive results. IGALMI® is currently FDA‑approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings, and the planned sNDA seeks to expand use to at‑home settings.

Insights

Regulatory affairs analyst

BTAI sets early Q1 2026 target for IGALMI at‑home sNDA.

BioXcel Therapeutics signals a clear next step by aiming to finish the IGALMI® at‑home sNDA submission in early Q1 2026. The package is anchored by the SERENITY At-Home pivotal Phase 3 safety trial and a correlation study, both described as positive for safety and exploratory efficacy.

Because this is a timing update, commercial impact depends on subsequent FDA review and outcomes. The product is already approved for medically supervised settings; the filing seeks to extend use to at‑home settings.

The key gating item is completion of the sNDA in early Q1 2026, after which regulatory review steps would follow per standard processes.

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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): October 30, 2025

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 October 30, 2025, BioXcel Therapeutics, Inc. (the “Company”) provided an update regarding the expected timing of submission of a Supplemental New Drug Application (sNDA) for a label expansion of IGALMI®, which is FDA-approved and marketed for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings. With the recent progress toward finalizing clinical study reports and additional components of the sNDA package, the Company now expects to complete the submission early in the first quarter of 2026.

In August 2025, the Company completed the SERENITY At-Home Pivotal Phase 3 Safety Trial for Agitation Associated with Bipolar Disorders or Schizophrenia and announced positive topline safety and exploratory efficacy data. In October 2025, the Company completed a correlation study supporting the SERENITY At-Home exploratory efficacy outcomes and announced positive results. The data from these trials are a key part of the Company’s planned sNDA submission seeking to expand the label of IGALMI® for at-home use.

Forward-Looking Statements

This current report includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this current report other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the planned sNDA submission.  When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI^®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company’s product candidates may not be accepted by physicians or the medical community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects or potential of misuse of the Company’s product candidates that could impact regulatory approval; its novel approach to the discovery and development of product candidates based on EvolverAI or our AI platform; the significant influence of and dependence on BioXcel LLC; failure to maintain compliance with Nasdaq’s listing standards; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well the factors discussed under the caption “Risk Factors” in its most recent Quarterly Report on Form 10-Q, as such factors may be updated from time to time in its other filings with the SEC. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this current report. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this current report.

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: October 30, 2025	BIOXCEL THERAPEUTICS, INC.
		/s/ Richard Steinhart
	By:	Richard Steinhart
	Title:	Chief Financial Officer