BioXcel Therapeutics (BTAI) gets FDA review date for IGALMI at-home agitation use

Rhea-AI Filing Summary

BioXcel Therapeutics, Inc. reported that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application for IGALMI. The filing covers use for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home, outpatient setting.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026, which is when the agency is scheduled to complete its review of this application.

Insights

Biopharma regulatory analyst

FDA acceptance of IGALMI sNDA sets a clear review timeline but does not yet change approval status.

The company states that the FDA has accepted a supplemental New Drug Application for IGALMI for acute agitation in bipolar disorders or schizophrenia in the at-home outpatient setting. Acceptance means the FDA has agreed to review the application as complete.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026, providing a defined review timeline. Actual outcomes, such as approval, labeling, or required studies, are not described here and will depend on the FDA’s assessment at or before that date.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Figures

PDUFA target action date: November 14, 2026

1 metrics

PDUFA target action date November 14, 2026 FDA review timeline for IGALMI supplemental New Drug Application

Key Terms

supplemental New Drug Application, Prescription Drug User Fee Act (PDUFA), PDUFA target action date, at-home (outpatient) setting

4 terms

supplemental New Drug Application regulatory

"the U.S. Food and Drug Administration has accepted its supplemental New Drug Application for the acute treatment"

A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.

Prescription Drug User Fee Act (PDUFA) regulatory

"The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026."

The Prescription Drug User Fee Act (PDUFA) is a law that allows drug companies to pay fees to the government to help speed up the review process for new medicines. This funding aims to ensure that important drugs reach patients faster, which can influence a company's ability to bring products to market efficiently. For investors, PDUFA-related decisions can impact drug approval timelines and company performance.

PDUFA target action date regulatory

"The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026."

The PDUFA target action date is the deadline set by the U.S. Food and Drug Administration (FDA) by which it aims to decide whether to approve or reject a new drug application. This date helps investors gauge when a company’s new medication might reach the market, potentially influencing sales and revenue expectations. It acts as a key milestone signaling progress in the drug approval process.

at-home (outpatient) setting medical

"for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI."

Understanding 8-K Material 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

FAQ

What regulatory update did BioXcel Therapeutics (BTAI) announce about IGALMI?

BioXcel Therapeutics announced that the FDA accepted its supplemental New Drug Application for IGALMI. The application covers acute treatment of agitation from bipolar disorders or schizophrenia in an at-home outpatient setting, advancing IGALMI through a formal FDA review process.

What is the PDUFA target action date for BioXcel Therapeutics’ IGALMI sNDA?

The FDA assigned a PDUFA target action date of November 14, 2026, for the IGALMI supplemental application. This date marks when the FDA is scheduled to complete its review, although the outcome of that review is not described here.

What indication is BioXcel Therapeutics seeking for IGALMI in this FDA review?

The supplemental New Drug Application seeks approval for IGALMI for acute treatment of agitation associated with bipolar disorders or schizophrenia. It specifically focuses on use in the at-home, outpatient setting, expanding beyond traditional in-facility treatment environments.

Does the FDA’s acceptance of the IGALMI sNDA mean IGALMI is approved for at-home use?

No, acceptance of the IGALMI supplemental New Drug Application means the FDA will formally review the submission. Approval for at-home use in bipolar disorder or schizophrenia agitation would depend on the FDA’s decision by the November 14, 2026 PDUFA target date.

How does this filing affect the development timeline for BioXcel’s IGALMI?

The filing establishes a defined regulatory timeline by setting a November 14, 2026 PDUFA target date. This date guides when the FDA expects to complete its review of IGALMI’s at-home agitation treatment application, though the final decision and any conditions remain unspecified here.

Filing Exhibits & Attachments

3 documents

Other Documents

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