Bioxcel Therapeutics, INC 8-K filings

BioXcel Therapeutics has amended its credit agreement, extending the deadline for a material transaction to August 21, 2026, and lowering its minimum liquidity requirement.

BioXcel Therapeutics has entered into an Eleventh Amendment to its Credit Agreement, deferring a principal payment and reducing liquidity covenants.

BioXcel Therapeutics has entered into a Tenth Amendment to its Credit Agreement, deferring principal payments, reducing liquidity covenants, and initiating a strategic review process.

BioXcel Therapeutics reported Q1 2026 financial results, announced an FDA PDUFA date for IGALMI's at-home use, and is exploring strategic options to maximize shareholder value.

BioXcel Therapeutics issued warrants to purchase 1,353,729 shares of common stock to lenders in connection with the Ninth Amendment to its Credit Agreement.

The FDA has accepted BioXcel Therapeutics' supplemental New Drug Application for IGALMI for at-home treatment of agitation associated with bipolar disorders or schizophrenia.

BioXcel Therapeutics reported its full-year 2025 financial results and provided an update on its sNDA submission for IGALMI in the at-home setting, targeting potential approval by year-end 2026.

BioXcel Therapeutics announced an updated market opportunity assessment for IGALMI in the at-home setting for acute agitation, showing significant potential.

BioXcel Therapeutics implements new milestone and retention bonus agreements for key employees, including its CEO, following a recent sNDA submission for IGALMI.

BioXcel Therapeutics submitted an sNDA to the FDA for IGALMI, aiming to expand its use for at-home treatment of agitation associated with bipolar disorders or schizophrenia.

BioXcel Therapeutics appoints Mark Pavao as Interim Chief Commercial Officer to support the potential at-home launch of IGALMI and plans sNDA submission this month.

BioXcel Therapeutics, Inc. stockholders approved a reverse stock split proposal and elected three Class I directors at their annual meeting on December 12, 2025.

BioXcel Therapeutics reported third-quarter 2025 financial results, highlighted by positive safety data for BXCL501 in at-home agitation and plans for an early Q1 2026 sNDA submission.

BioXcel Therapeutics announced positive safety and efficacy signals from its Phase 3 study of BXCL501 for agitation in bipolar disorder and schizophrenia in the home setting.

BioXcel Therapeutics announced a delay in its Supplemental New Drug Application submission for IGALMI's at-home use label expansion, now expected in early Q1 2026.

BioXcel Therapeutics announced positive results from a correlation study supporting the use of a modified scale for assessing acute agitation in at-home settings, paving the way for a Q1 2026 sNDA submission.

BioXcel Therapeutics announced the completion of a key clinical trial enrollment and a significant capital raise, extending its cash runway into Q1 2026.

BioXcel Therapeutics announced positive exploratory efficacy data for BXCL501 in its SERENITY At-Home Phase 3 trial, reinforcing its potential for outpatient use and revealing a significantly larger addressable market.

BioXcel Therapeutics announced its SERENITY At-Home Pivotal Phase 3 trial for BXCL501 successfully met its primary safety and tolerability endpoint, paving the way for a label expansion submission.

BioXcel Therapeutics, Inc. filed a legal opinion to facilitate the sale of up to $80 million in common stock through its existing At-The-Market (ATM) equity distribution program.

BioXcel Therapeutics received positive pre-sNDA meeting comments from the FDA for BXCL501 in agitation, keeping its Q1 2026 submission on track.

BioXcel Therapeutics, Inc. received positive preliminary comments from the U.S. Food and Drug Administration (FDA) regarding its upcoming pre-sNDA meeting.

BioXcel Therapeutics reports Q2 2025 financial results with increased net losses and declining revenue, while advancing its SERENITY At-Home Phase 3 trial with topline data expected soon.

BioXcel Therapeutics announced its CEO will participate in an upcoming conference and confirmed it has met its Oaktree financing covenant by raising approximately $30.4 million.

BioXcel Therapeutics projects a significantly larger commercial opportunity for BXCL501 in the at-home treatment of agitation associated with bipolar disorders and schizophrenia.

BioXcel Therapeutics announced a peer-reviewed study showing Dexmedetomidine, the active ingredient in BXCL-501, effectively regulates stress-mediated behaviors, suggesting broader applications.

BioXcel Therapeutics, Inc. announced the completion of the last patient last visit in its pivotal Phase 3 SERENITY At-Home Safety Trial for acute agitation associated with bipolar disorders or schizophrenia, with topline results expected this month.

BioXcel Therapeutics, Inc. announced the submission of a pre-supplemental New Drug Application meeting package to the U.S. Food and Drug Administration for IGALMI, seeking label expansion for outpatient use in treating agitation associated with bipolar disorders or schizophrenia.

BioXcel Therapeutics, Inc. announced the allowance of a crucial U.S. patent application for its drug IGALMI, covering specific dosing for acute agitation in schizophrenia and bipolar disorder, which will extend patent protection until 2043.

BioXcel Therapeutics, Inc. announced it received an extension from Nasdaq until September 16, 2025, to regain compliance with the $35 million market value of listed securities rule.