BioXcel Therapeutics Files 8-K

TL;DR

BXcel filed an 8-K, something happened.

AI Summary

BioXcel Therapeutics, Inc. filed an 8-K on August 27, 2025, reporting an event under 'Other Events'. The filing does not contain specific details about the event, dollar amounts, or names beyond the company's own information.

Why It Matters

This filing indicates a material event has occurred for BioXcel Therapeutics, Inc., requiring disclosure to investors.

Risk Assessment

Risk Level: low — The filing is a standard disclosure form without specific negative or positive financial or operational details.

Key Players & Entities

• BioXcel Therapeutics, Inc. (company) — Registrant
• August 27, 2025 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of incorporation
• 001-38410 (filing_id) — SEC File Number
• 555 Long Wharf Drive (address) — Principal executive offices
• New Haven (city) — Principal executive offices
• CT (state) — Principal executive offices
• 06511 (zip_code) — Principal executive offices
• (475) 238-6837 (phone_number) — Registrant's telephone number

FAQ

Key Financial Figures

• $0.001 B — ch registered Common Stock, par value $0.001 BTAI The Nasdaq Capital Market Indic

Filing Documents

• tm2524474d1_8k.htm (8-K) — 73KB
• 0001104659-25-083402.txt ( ) — 239KB
• btai-20250827.xsd (EX-101.SCH) — 3KB
• btai-20250827_lab.xml (EX-101.LAB) — 33KB
• btai-20250827_pre.xml (EX-101.PRE) — 22KB
• tm2524474d1_8k_htm.xml (XML) — 3KB

01 Other Events

Item 8.01 Other Events. On August 27, 2025, BioXcel Therapeutics, Inc. (the "Company") announced that the SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, the Company's proprietary, sublingual film formulation of dexmedetomidine, as an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting, met its primary endpoint. The SERENITY At-Home Pivotal Phase 3 trial is a double-blind, placebo-controlled 12 week trial designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The data from this successful study will form the basis of the sNDA submission for label expansion of IGALMI in the at-home setting planned for the first quarter of 2026. SERENITY At-Home Topline Summary Summary of agitation episodes: A total of 246 patients randomized Data collected 2628 agitation episodes in 215 patients Treated 2437 episodes in 208 patients 168 patients (81%) completed the full 12-week trial Average of 11.7 agitation episodes recorded per treated patient All patients were able to successfully self-administer the film Distribution of enrolled patients was 45% bipolar disorders and 55% schizophrenia SERENITY AT-Home Primary Endpoint Data The 120 mcg dose of BXCL501 was well-tolerated in patients with episodes of agitation in the outpatient setting and met the primary objective. This tolerability outcome was observed across repeat dosing and through the duration of the trial. No discontinuations due to tolerability in the BXCL501 arm Adverse event profile consistent with approved IGALMI label and multiple clinical trials in the institutional setting o No drug-related serious adverse events (SAEs), syncopes or falls reported o No new or unexpected treatment emergent adverse events (TEAEs) o No severe TEAEs associated with BXCL501 treatment and most TEAEs were mild o No t

Forward-Looking Statements

Forward-Looking Statements This current report includes "forward-looking 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 Company's planned advancement of its SERENITY program; potential market opportunity for BXCL501; release of data from the SERENITY At-Home trial; the submission of an sNDA to the FDA; the supply of IGALMI through existing distribution channels; the potential for the results from the Company's completed, ongoing and proposed clinical trials to support regulatory approvals for its product candidate. 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 c

SIGNATURES

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 27, 2025 BIOXCEL THERAPEUTICS, INC. /s/ Richard Steinhart By: Richard Steinhart Title: Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR