Positive FDA pre-sNDA feedback for BioXcel (NASDAQ: BTAI)

Rhea-AI Filing Summary

BioXcel Therapeutics, Inc. reported receiving positive preliminary meeting comments from the U.S. Food and Drug Administration (FDA) ahead of a planned pre-supplemental New Drug Application (pre-sNDA) meeting scheduled for August 20, 2025. The company is reviewing this feedback and plans to provide an update next week. The upcoming pre-sNDA meeting is intended to align with the FDA on the proposed format and content of BioXcel’s planned sNDA submission, covering clinical, nonclinical, and chemistry, manufacturing and controls (CMC) requirements.

Insights

Biopharma regulatory analyst

BioXcel receives encouraging early FDA feedback before a key pre-sNDA meeting.

BioXcel Therapeutics reports positive preliminary comments from the FDA related to a pre-sNDA meeting scheduled for August 20, 2025. Pre-sNDA interactions typically focus on the structure and content of a planned supplemental New Drug Application rather than final efficacy or safety judgments, but favorable early feedback can smooth the review pathway.

The company states that the primary goal of the meeting is to gain alignment on the proposed format and content of the sNDA, including clinical, nonclinical and CMC components. Alignment at this stage can reduce the risk of significant information gaps or re-work after submission, though it does not imply any regulatory approval decision.

BioXcel plans to provide an update next week after further evaluating the FDA’s feedback and holding the scheduled meeting. Subsequent disclosures about the agreed clinical, nonclinical and CMC expectations will help clarify the scope and timing of the eventual sNDA submission.

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.

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): August 14, 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 August 14, 2025, BioXcel Therapeutics, Inc. (the “Company”) received positive preliminary meeting comments from the U.S. Food and Drug Administration (FDA) related to the pre-sNDA meeting scheduled for August 20, 2025. The Company is evaluating the feedback from the FDA and plans to provide an update next week.

The primary purpose of the planned pre-sNDA meeting is to gain alignment with the FDA regarding the proposed format and content of the Company’s planned sNDA submission, including the clinical, nonclinical and chemistry, manufacturing and controls (CMC) requirements.

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

FAQ

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

BioXcel Therapeutics disclosed that it received positive preliminary meeting comments from the U.S. FDA related to a planned pre-sNDA meeting scheduled for August 20, 2025, and that it is evaluating this feedback and will provide an update next week.

What is the purpose of BioXcel Therapeutics' upcoming pre-sNDA meeting with the FDA?

The pre-sNDA meeting’s primary purpose is to gain alignment with the FDA on the proposed format and content of BioXcel’s planned sNDA submission, including the clinical, nonclinical, and CMC requirements.

When is BioXcel Therapeutics' pre-sNDA meeting with the FDA scheduled?

BioXcel Therapeutics’ pre-sNDA meeting with the FDA is scheduled for August 20, 2025.

How did the FDA respond so far to BioXcel Therapeutics' plans for an sNDA?

The company reports receiving positive preliminary meeting comments from the FDA regarding the planned pre-sNDA meeting, suggesting an encouraging early dialogue around the upcoming sNDA planning.

When does BioXcel Therapeutics expect to provide further updates on the FDA feedback?

BioXcel Therapeutics states that it is evaluating the FDA’s feedback and plans to provide an update next week following the pre-sNDA meeting process.

Does this BioXcel Therapeutics filing indicate FDA approval of its product?

No. The disclosure only states that the company received positive preliminary meeting comments and is preparing for a pre-sNDA meeting focused on submission format and content; it does not report any FDA approval.