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

Rhea-AI Filing Summary

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) filed a Form 8-K on 15 July 2025 to disclose a patent milestone for its commercial product Igalmi. The U.S. Patent & Trademark Office has allowed U.S. Patent Application No. 18/600,419, which covers administration of a single oromucosal dose of up to 120 mcg dexmedetomidine for treating acute agitation associated with schizophrenia or bipolar disorder in patients exhibiting a QT prolongation of <6 µs. Once issued, the patent will be eligible for Orange Book listing and will become the 14th Orange Book-listed patent for Igalmi. The patent carries an expiry date of 12 January 2043, subject to any patent-term adjustment. No financial metrics or other operational updates were included in this filing.

• Form type: 8-K – Item 8.01 (Other Events)
• Event date: 15 July 2025
• Key asset: Igalmi (dexmedetomidine oromucosal film)
• IP impact: additional Orange Book protection through 2043, strengthening the product’s U.S. exclusivity position

Positive

• USPTO allowance of Patent Application 18/600,419 with claims matching the FDA-recommended Igalmi dosing regimen.
• Patent will become the 14th Orange Book-listed patent for Igalmi, extending U.S. protection to 12 January 2043.

Negative

• None.

Insights

Securities Analyst

Newly allowed patent extends Igalmi exclusivity to 2043 and adds 14th Orange Book listing, a positive IP development despite lack of immediate financial metrics.

The allowance of Application 18/600,419 materially expands BioXcel’s intellectual-property shield around Igalmi. With an expiry in 2043, the company secures roughly 17.5 more years of statutory protection from the allowance date, which may deter generic challengers during that window. While the filing contains no sales or earnings data, patent additions of this length are typically viewed favorably by investors who value prolonged revenue visibility. Because this 8-K is focused solely on the IP event, the disclosure is impactful yet limited in scope, warranting a positive rating.

Intellectual Property Specialist

Orange Book eligibility of USPTO-allowed single-dose dexmedetomidine patent tightens Igalmi’s patent estate through 2043, complicating generic entry timelines.

The patent’s claims track the FDA-recommended dosing for Igalmi in a defined subpopulation, enhancing enforceability because they mirror the approved label. Orange Book listing provides an automatic notification framework—any ANDA filer must certify against this patent, triggering potential 30-month stays if contested. Becoming the 14th Orange Book patent, the estate now covers both formulation and method-of-use aspects, creating layered barriers. The 2043 expiry materially lengthens exclusivity relative to standard 20-year terms, signaling strong protection for the product’s commercial life cycle.

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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): July 15, 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 July 15, 2025, BioXcel Therapeutics, Inc. announced that the United States Patent and Trademark Office had allowed U.S. Patent Application No. 18/600,419 with claims pertaining to the administration of a single dose of up to 120 mcg of dexmedetomidine in an oromucosal formulation for the treatment of acute agitation associated with schizophrenia or bipolar disorder in certain patient subpopulations where the patient exhibits a maximum allowed QT prolongation of less than six microseconds. The allowed claims mirror the recommended IGALMI dosing regime for treatment of patients meeting this QT prolongation criteria. Once issued, this patent will be eligible for listing in the Orange Book for Igalmi and will be the 14th Orange Book listed patent for Igalmi. This patent will have an expiry date of January 12, 2043, subject to patent term adjustment.

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: July 15, 2025	BIOXCEL THERAPEUTICS, INC.
		/s/ Richard Steinhart
	By:	Richard Steinhart
	Title:	Chief Financial Officer

FAQ

What did BioXcel Therapeutics (BTAI) announce in its July 15 2025 Form 8-K?

The company reported USPTO allowance of Patent Application 18/600,419 covering single-dose oromucosal dexmedetomidine for acute agitation.

Which product benefits from the newly allowed patent?

The patent is associated with Igalmi, BioXcel’s dexmedetomidine oromucosal film used to treat acute agitation.

How many Orange Book patents will Igalmi have once this patent issues?

Igalmi will have 14 Orange Book-listed patents after issuance.

What is the expiration date of the allowed patent for Igalmi?

The patent is set to expire on 12 January 2043, subject to any term adjustment.

What dosage does the patent cover?

It covers a single dose of up to 120 mcg dexmedetomidine administered oromucosally.

Which patient subpopulation is specified in the patent claims?

Patients with acute agitation from schizophrenia or bipolar disorder who exhibit a QT prolongation of less than 6 µs.