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Material updates from SEC filings (8-K, 10-Q, 10-K) ranked by impact, with no firehose noise.
Results of Operations and Financial Condition. On May 15, 2026, BioXcel Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended March 31, 2026 and provided a business update. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. The information disclosed under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shall not be deeme…
Unregistered Sales of Equity Securities. On March 27, 2026, BioXcel Therapeutics, Inc. (the “Company”) entered into the Ninth Amendment to the Credit Agreement and Guaranty, dated April 19, 2022, as amended (“Ninth Amendment”). Pursuant to the terms of the Ninth Amendment, on April 15, 2026, the Company granted the lenders under the Ninth Amendment (the “Lenders”) warrants to purchase up to 1,353,729 shares of common stock at an exercise price of $0.01 per share (the “Amendment Warrants”). Th…
Results of Operations and Financial Condition. On March 27, 2026, BioXcel Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months and year ended December 31, 2025 and provided a business update. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. The information disclosed under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shal…
Entry into a Material Definitive Agreement. Registered Direct Offering and Warrant Amendment On March 10, 2026, BioXcel Therapeutics, Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with the purchaser named therein (the “Purchaser”). Pursuant to the Purchase Agreement, the Company agreed to issue and sell to the Purchaser and the Purchaser agreed to buy in a registered direct offering (the “Offering”) (i) an aggregate of 2,480,294 shares (the “Shar…
Other Events. On February 12, 2026, BioXcel Therapeutics, Inc. (the “Company”) announced the completion of an updated market opportunity assessment for IGALMI® for acute agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting, informed by results from the SERENITY At-Home clinical study. The Company submitted a supplemental New Drug Application (sNDA) last month seeking the FDA’s approval of IGALMI for at-home use in the acute treatment of agitation as…
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On February 4, 2026, BioXcel Therapeutics, Inc. (the “Company”), following the Company’s recent submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI ® , entered in…
Other Events. On January 12, 2026, BioXcel Therapeutics, Inc. (the “Company”) announced that Mark Pavao is joining the Company as Interim Chief Commercial Officer to support the potential launch of IGALMI in the at-home setting. The Company plans to submit a supplemental New Drug Application (sNDA) this month seeking the FDA’s approval of IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. Forward-Looking Statements This Current Repor…
Results of Operations and Financial Condition. On November 12, 2025, BioXcel Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended September 30, 2025 and provided a business update. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. The information disclosed under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shall not…
Other Events. On October 30, 2025, BioXcel Therapeutics, Inc. (the “Company”) provided an update regarding the expected timing of submission of a Supplemental New Drug Application (sNDA) for a label expansion of IGALMI®, which is FDA-approved and marketed for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings. With the recent progress toward finalizing clinical study reports and additional components of the sNDA package,…
Other Events. On October 14, 2025, BioXcel Therapeutics, Inc. (the “Company”) announced positive results from the correlation study related to exploratory efficacy outcomes from the SERENITY At Home trial. The results, along with the data from the SERENITY At Home trial, will be included in the supplemental New Drug Application (sNDA) submission that is planned for the first quarter of 2026. The standard method for measuring acute agitation associated with schizophrenia and bipolar disorder i…
Regulation FD. On September 15, 2025, BioXcel Therapeutics, Inc. (the “Company”) provided the following corporate and financing updates: Clinical Trial Update On September 13, 2025, the Company completed enrollment in its open label clinical study designed to evaluate the correlation between the patient-and informant-reported mCGI-S measurement and the Positive and Negative Syndrome Scale-Excitatory Component (“PEC”) scale, conducted by trained raters. The study was designed to evaluate appro…
of this Current Report on Form 8-K and incorporated herein by reference, other than the sixth paragraph. Forward-Looking Statements This current report includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act…
Other Events. On September 10, 2025, BioXcel Therapeutics, Inc. (the “Company”) announced positive topline exploratory efficacy data from SERENITY At-Home Pivotal Phase 3 safety trial for agitation associated with bipolar disorders or schizophrenia The SERENITY At-Home study is a Pivotal Phase 3, double-blind, placebo-controlled, 12-week clinical trial designed to evaluate the safety of BXCL501 (120 mcg dose) for the acute treatment of agitation associated with bipolar disorders or schizophre…
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…
Other Events. On August 18, 2025, BioXcel Therapeutics, Inc. (the “Company”) announced it had received positive pre-sNDA meeting comments from the U.S. Food and Drug Administration (“FDA”) for the planned supplemental new drug application (“sNDA”) submission for BXCL501 in agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting. Based on the FDA’s feedback, the Company believes that the planned sNDA regulatory package will be sufficient to support the…
Other Events. ATM Opinion Filing On April 3, 2025, the Company entered into an Equity Distribution Agreement with Canaccord Genuity LLC to sell shares of Common Stock through any method permitted that is deemed an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, under which Canaccord Genuity LLC will act as sales agent (the “ATM Program”). On August 18, 2025 the Company filed a prospectus supplement with the Securities and Exchange Commission…
Results of Operations and Financial Condition. On August 12, 2025, BioXcel Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended June 30, 2025 and providing a business update. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. The information disclosed under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shall not be de…
Regulation FD Disclosure. Participation in Canaccord Genuity Conference On August 11, 2027, BioXcel Therapeutics, Inc. (the “Company”) issued a press release announcing that Vimal Mehta, Ph.D., CEO of the Company, will participate in a fireside chat at the Canaccord Genuity 45th Annual Growth Conference in Boston on Tuesday, Aug. 12, 2025, at 12 p.m. ET. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is hereby incorporated by reference herein. C…
Other Events. On August 1, 2025, BioXcel Therapeutics, Inc. (the “Company”) announced the last patient last visit in the SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia. The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study 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 se…
Other Events. On July 21, 2025, BioXcel Therapeutics, Inc. (the “Company”) announced the submission of a pre-supplemental New Drug Application (pre-sNDA) meeting package to the U.S. Food and Drug Administration (FDA) for IGALMI® in support of a potential label expansion for outpatient use for the acute treatment of agitation associated with bipolar disorders or schizophrenia. The primary purpose of the pre-sNDA meeting, scheduled for August 20, 2025, is to gain alignment with the FDA regardin…
Results of Operations and Financial Condition. On May 12, 2024, BioXcel Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended March 31, 2025 and provided a business update. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. The information disclosed under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shall not be deeme…
Entry into a Material Definitive Agreement. On April 3, 2025, BioXcel Therapeutics, Inc. (the “Company”) entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Canaccord Genuity LLC (“Canaccord”) to sell shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), from time to time, through an “at the market” equity offering program under which Canaccord will act as sales agent. Subject to the terms and conditions of the Equity Distr…
Results of Operations and Financial Condition. On March 27, 2025, BioXcel Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months and year ended December 31, 2024 and provided a business update. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. The information disclosed under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shal…
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing As previously reported, on September 20, 2024, BioXcel Therapeutics, Inc. (the “Company”) received a letter from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that for the 30 consecutive business days prior to the date of the letter, the Company’s market value of listed securities (“MVLS”) closed below the minimum $35 million…
Entry into a Material Definitive Agreement. On March 3, 2025, BioXcel Therapeutics, Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with the purchaser named therein (the “Purchaser”). Pursuant to the Purchase Agreement, the Company agreed to issue and sell to the Purchaser and the Purchaser agreed to buy in a registered direct offering (the “Offering”) (i) an aggregate of 188,383 shares (the “Shares”) of common stock, par value $0.001 per share (“C…
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