Completes clinical trials required by FDA for sNDA submission planned for the first quarter of 2026 NEW HAVEN, Conn., Oct. 14, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced positive results from the correlation study related to exploratory efficacy outcomes from the SERENITY... Read More

NEW HAVEN, Conn., Oct. 13, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI) , a biopharmaceutical company pioneering the use of artificial intelligence to develop transformative medicines in neuroscience, announced today that CEO Vimal Mehta, Ph.D., and members of the BioXcel team will ring the Nasdaq Stock Market Closing Bell on Tuesday, October 14, 2025. This honor marks a pivotal moment for the company —... Read More

NEW HAVEN, Conn., Sept. 18, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it has received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has regained compliance with the market value of listed... Read More

BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p<.05) Complete resolution of agitation was significantly higher with BXCL501 compared to placebo across agitation episode severity (p<.0001) BXCL501 showed a similar reduction in agitation symptoms over both the duration of the trial and number of treated episodes, demonstrating... Read More

NEW HAVEN, Conn., Sept. 04, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, will present a company overview at the H.C. Wainwright 27 th Annual Global Investment Conference to be held September 8 - 10, 2025. Date: Monday,... Read More

BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia No discontinuations for tolerability in the BXCL501 arm While not the primary objective of the SERENITY At-Home trial, the preliminary results demonstrate continued effects and consistent benefit with repeat dosing across the course of the trial... Read More

BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia No discontinuations for tolerability in the BXCL501 arm While not the primary objective of the SERENITY At-Home trial, the preliminary results demonstrate continued effects and consistent benefit with repeat dosing across the course of the trial... Read More

Company to host conference call at 8 a.m. ET, August 27, 2025 NEW HAVEN, Conn., Aug. 26, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ( Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it will host an investor call and live webcast at 8 a.m. ET, August 27, 2025 to review topline data from the SERENITY At-Home Pivotal... Read More

Data from more than 2,600 agitation episodes collected Topline data readout is on track for August NEW HAVEN, Conn., Aug. 19, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced completion of the database lock for its SERENITY At-Home pivotal Phase 3 safety trial for acute... Read More

Achieved alignment with the FDA on sNDA package to expand the IGALMI label for the At-Home (Outpatient) setting sNDA submission on track for Q1 2026 NEW HAVEN, Conn., Aug. 18, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it has received positive pre-sNDA meeting... Read More

NEW HAVEN, Conn., Aug. 13, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, will participate in a virtual fireside chat on Thursday, August 14, 2025 at 1:00 p.m. ET as part of the H.C. Wainwright & Co. “HCW@Home” series.... Read More

Topline data from SERENITY At-Home Phase 3 trial for acute treatment of agitation associated with bipolar disorders or schizophrenia expected in August FDA meeting scheduled in August and is intended to support potential sNDA submission for label expansion of IGALMI ® in the at-home setting Publication of non-clinical data in Frontiers in Pharmacology suggests potential applications of BXCL501 in chronic conditions BioXcel... Read More

NEW HAVEN, Conn., Aug. 11, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, 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. To... Read More

Dexmedetomidine demonstrated a significant reduction in stress-induced behaviors, suggesting potential applications of BXCL501 in chronic psychiatric disorders in addition to treatment of acute agitation Leading academic institutions are evaluating BXCL-501 in clinical studies for multiple chronic conditions NEW HAVEN, Conn., Aug. 06, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical... Read More

Vast majority of patients dosed completed the full 12-week study Data from more than 2,200 agitation episodes collected Topline data readout anticipated this month NEW HAVEN, Conn., Aug. 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced completion of the last patient last... Read More

Company focused on obtaining approval for outpatient (at-home) use of IGALMI® for the acute treatment of agitation associated with bipolar disorders or schizophrenia Pre-Supplemental New Drug Application meeting with FDA scheduled for August 20, 2025 NEW HAVEN, Conn., July 21, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop... Read More

DSMB recommended the continuation of trial as planned Topline data expected in Q3 2025 NEW HAVEN, Conn., July 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced the second positive recommendation by an independent Data Safety Monitoring Board (DSMB) to continue, without... Read More

DSMB recommended the continuation of trial as planned Topline data expected in Q3 2025 NEW HAVEN, Conn., May 27, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that an independent Data Safety Monitoring Board (DSMB) recommended that the SERENITY At-Home pivotal Phase 3 safety... Read More

NEW HAVEN, Conn., May 27, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that the Nasdaq Hearings Panel granted the Company’s request to continue its listing on The Nasdaq Stock Market. During a Nasdaq Panel hearing held on May 1, 2025, the Panel reviewed the Company’s plan... Read More

Enrollment complete in SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia Topline data expected in second half of 2025 intended to support potential sNDA submission for label expansion of IGALMI ® in the at-home setting NEW HAVEN, Conn., May 12, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company... Read More

Enrollment exceeds 60% of required number of patients in SERENITY At-Home pivotal Phase 3 safety trial evaluating 200 patients for acute treatment of agitation associated with bipolar disorders or schizophrenia Topline data expected in second half of 2025 intended to support potential sNDA submission for label expansion of IGALMI ® in the at-home setting Strengthened cash position to advance BXCL501 program NEW HAVEN, Conn.,... Read More

Topline data expected in second half of 2025 to support potential sNDA submission for label expansion of IGALMI ® in the home setting Company has $35M of cash following closing of recent equity financing NEW HAVEN, Conn., March 11, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today... Read More

Data to support potential sNDA submission for label expansion of IGALMI ® in the home setting Topline data expected in second half of 2025 NEW HAVEN, Conn., March 07, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced it has reached 33% enrollment in its 200-patient SERENITY... Read More

NEW HAVEN, Conn., March 04, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced the closing of its previously announced registered direct offering of 4,000,000 shares (the “Shares”) of common stock, par value $0.001 per share (“Common Stock”) (or common stock... Read More

NEW HAVEN, Conn., March 03, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it has entered into a securities purchase agreement with certain institutional investors for the purchase and sale in a registered direct offering of 4,000,000 shares (the... Read More

FDA concludes site inspection is closed under 21 C.F.R.20.64(d)(3); Voluntary Action Indicated Company believes this further supports reliability of data from TRANQUILITY II trial of BXCL501 NEW HAVEN, Conn., March 03, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that the... Read More

NEW HAVEN, Conn., Feb. 28, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it has received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has regained compliance with the minimum closing bid price... Read More

NEW HAVEN, Conn., Feb. 06, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it will effect a 1-for-16 reverse stock split of its common stock. The reverse stock split will become effective at 5:00 p.m. Eastern Time on February 7, 2025, with the company’s common stock... Read More

Patient enrollment advancing in SERENITY At-Home Phase 3 trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia Developed plans for TRANQUILITY In-Care Phase 3 trial of BXCL501 for agitation associated with Alzheimer’s dementia Enhanced operational and financial flexibility through existing credit amendment Strengthened strategic leadership with recent Board appointments NEW... Read More

NEW HAVEN, Conn., Nov. 22, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced the pricing of an underwritten public offering of 5,600,000 shares of its common stock, par value $0.001 per share (“Common Stock”), and accompanying... Read More

NEW HAVEN, Conn., Nov. 21, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it has commenced an underwritten public offering of shares of its common stock, par value $0.001 per share (“Common Stock”), and accompanying warrants... Read More

Advancing two pivotal Phase 3 trials of BXCL501 for acute treatment of agitation associated with bipolar disorders, schizophrenia, and Alzheimer’s dementia Conference call set for 8:00 a.m. ET today NEW HAVEN, Conn., Nov. 14, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced its... Read More

First patient randomized in SERENITY At-Home trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia Received FDA feedback on protocol for TRANQUILITY In-Care trial of BXCL501 for agitation associated with Alzheimer’s dementia (AAD) Estimated 140 million annual acute agitation episodes associated with these conditions 1-3 NEW HAVEN, Conn., Nov. 12, 2024 (GLOBE NEWSWIRE) -- BioXcel... Read More

NEW HAVEN, Conn., Nov. 08, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it will release its third quarter 2024 financial results on Thursday, November 14, 2024, before the open of the U.S. financial markets. The Company’s management team will also host a conference... Read More

NEW HAVEN, Conn., Oct. 29, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that Vimal Mehta, Ph.D., CEO, and Vincent J. O’Neill, M.D., Executive Vice President, Chief of Product Development and Medical Officer, will present at the ThinkEquity Conference in New York City. The... Read More

Phase 2a efficacy and safety trial enrollment initiation expected in H1 2025 ~40 million Americans go to emergency department annually after a traumatic experience 1 Second externally funded stress-related trial for BXCL501 NEW HAVEN, Conn., Oct. 15, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in... Read More

Recently initiated SERENITY At-Home pivotal Phase 3 trial for agitation associated with bipolar disorders or schizophrenia Submitted protocol to FDA for TRANQUILITY In-Care pivotal Phase 3 trial for agitation associated with Alzheimer’s dementia Company to maintain IGALMI™ in the market without current commercial infrastructure NEW HAVEN, Conn., Sept. 19, 2024 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a... Read More

Estimated 23 million annual agitation episodes in the at-home setting 1-3 No FDA-approved therapies in the at-home setting for acute treatment of agitation associated with bipolar disorders or schizophrenia NEW HAVEN, Conn., Sept. 05, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and... Read More

NEW HAVEN, Conn., Aug. 07, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, will participate in a fireside chat at the Canaccord Genuity 44th Annual Growth Conference in Boston on Tuesday, August 13, 2024... Read More

Planning initiation of SERENITY At-Home pivotal Phase 3 trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia Advancing plans for TRANQUILITY In-Care pivotal Phase 3 trial with BXCL501 for agitation associated with Alzheimer’s dementia Reported positive topline results from IGALMI™ post-marketing requirement (PMR) study Conference call set for 8:00 a.m. ET today NEW HAVEN,... Read More

NEW HAVEN, Conn., July 30, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its second quarter 2024 financial results on Tuesday, August 6, 2024, before the open of the U.S. financial markets. The Company’s management team will also host... Read More

Focused market-access strategy generates estimated net revenue of approximately $1.1 million, highest quarterly net revenue since commercial launch Represents 90% increase from the prior quarter and 141% increase from the second quarter of 2023 NEW HAVEN, Conn., July 16, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative... Read More

Study achieved its objective and demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with 180 mcg dose (highest approved dose) For each episode occurring over seven days, a reduction in agitation was observed and no serious adverse events were reported following treatment Results supportive of Phase 3 SERENITY... Read More

NEW HAVEN, Conn., May 28, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that CEO Vimal Mehta, Ph.D., will present at the Jefferies Global Healthcare Conference in New York City. The presentation is set for Wednesday, June 5 at 3 p.m. ET, and will... Read More

NEW HAVEN, Conn., May 21, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that Rob Risinger, M.D., Chief Medical Officer of Neuroscience, will deliver oral and poster presentations at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual... Read More

Advancing TRANQUILITY and SERENITY program plans for two pivotal Phase 3 trials to expand BXCL501 market potential in acute treatment of agitation Strengthened intellectual property portfolio for BXCL501 with grant of two new patents, in Japan and the U.S. Completed $25 million registered direct offering Conference call set for 8:00 a.m. ET today NEW HAVEN, Conn., May 09, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc.... Read More

NEW HAVEN, Conn., April 25, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its first quarter 2024 financial results on Thursday, May 9, 2024, before the open of the U.S. financial markets. BioXcel Therapeutics’ management team will... Read More

Poster presentation scheduled for June 1, 2024, 1:30-4:30 PM CT /2:30-5:30 PM ET Trial being led by Georgetown University’s Lombardi Comprehensive Cancer Center NEW HAVEN, Conn., April 24, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that a late-breaking... Read More

Company plans to initiate SERENITY At-Home pivotal Phase 3 safety trial with 120 mcg dose following recent meeting with FDA No FDA-approved therapies for acute treatment of agitation associated with bipolar disorders or schizophrenia in the home setting NEW HAVEN, Conn., April 22, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop... Read More

Company plans to initiate trial following recent meeting with FDA No FDA-approved therapies for acute treatment of AAD are currently available NEW HAVEN, Conn., April 10, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced details regarding the planned design... Read More

NEW HAVEN, Conn., March 25, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it has entered into a securities purchase agreement with investors in a registered direct offering of 3,054,609 shares (the “Shares”) of common... Read More

NEW HAVEN, Conn., March 15, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today reported that the European Patent Office (EPO) granted the Company’s European Patent No. 3,562,486 (the “486 patent”) on March 13, 2024. The 486 patent covers the use of dexmedetomidine... Read More

Provides update on two late-stage clinical programs for BXCL501 for potential treatment of agitation Recently completed meetings with U.S. Food and Drug Administration for TRANQUILITY and SERENITY programs Conference call and webcast set for 8:00 a.m. ET today NEW HAVEN, Conn., March 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to... Read More

NEW HAVEN, Conn., March 01, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its fourth quarter and full year 2023 financial results on Tues., March 12, 2024, before the open of the U.S. financial markets. BioXcel Therapeutics’... Read More

NEW HAVEN, Conn., Feb. 13, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that it has terminated its proposed public offering of $60.0 million of shares of its common stock or, in lieu of common stock to certain investors, pre-funded warrants to purchase... Read More

Designation for BXCL701 in combination with a checkpoint inhibitor (CPI) for treatment of patients with metastatic SCNC with progression on chemotherapy and no evidence of microsatellite instability BXCL701 is an investigational, oral innate immune activator designed to inflame the tumor microenvironment and augment CPI activity Company to discuss registration path at upcoming meeting with FDA NEW HAVEN, Conn., Feb. 12, 2024... Read More

NEW HAVEN, Conn., Feb. 08, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it has commenced an underwritten public offering of $60.0 million of shares of its common stock or, in lieu of common stock to certain investors that... Read More

Human proof of concept portion of the trial expected to begin in H1 2024; led by Georgetown Lombardi Comprehensive Cancer Center BXCL701 in combination with checkpoint inhibitor in preclinical studies demonstrated encouraging results in pancreatic cancer Initial study data expected in 2024 NEW HAVEN, Conn., Feb. 06, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing... Read More

Aligns with Company’s strategic focus on bringing to market BXCL501 for potential acute treatment of agitation for Alzheimer’s patients IGALMI™ market exclusivity further strengthened with receipt of issue notification for additional method of use patent (total of 8 U.S. patents, including 4 method of use patents) NEW HAVEN, Conn., Feb. 05, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a... Read More

Company to review BXCL502 and other potential emerging pipeline candidates Dr. Jeffrey Cummings to discuss agitation relief in Alzheimer’s disease and BXCL502 as a potential treatment for chronic use Dr. Sandra Comer to discuss BXCL501 as a potential treatment for opioid withdrawal NEW HAVEN, Conn., Dec. 12, 2023 (GLOBE NEWSWIRE) -- As previously announced, BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical... Read More

Vincent J. O’Neill, M.D., promoted to Executive Vice President, Chief of Product Development and Medical Officer Rajiv Patni, M.D., appointed Strategic Clinical Advisor to CEO and Board of Directors NEW HAVEN, Conn., Dec. 11, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology,... Read More

Company to review BXCL502 and other potential emerging pipeline candidates Dr. Jeffrey Cummings to discuss agitation relief in Alzheimer’s disease and BXCL502 as a potential treatment Dr. Sandra Comer to discuss BXCL501 as a potential treatment for opioid withdrawal NEW HAVEN, Conn., Nov. 30, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence... Read More

Company plans to conduct Phase 3 trial of BXCL501 in the at-home setting for TRANQUILITY program to support potential sNDA for acute treatment of agitation associated with dementia due to probable Alzheimer’s disease Potential market opportunity for BXCL501 to include acute treatment of agitation across full spectrum of Alzheimer’s-related dementia and agitation severity across all care settings Based on FDA feedback,... Read More

Median overall survival of 15.5 months with BXCL701 + KEYTRUDA® (pembrolizumab), compared to 9.6 months with checkpoint inhibitor monotherapy in late-line refractory patients in separate Phase 2 trial 1 59% of studied patients alive at one year following treatment with BXCL701 + KEYTRUDA Median progression-free survival of 4.2 months with BXCL701 + KEYTRUDA compared to 2.1 months with checkpoint inhibitor monotherapy in... Read More

Columbia University-led trial expected to add fourth site to target completion of 4-arm, 160-patient trial in 2024 Fentanyl adulterated or associated with xylazine (FAAX) designated an emerging threat by the White House Office of National Drug Control Policy 1 Company to seek FDA feedback on potential registrational paths NEW HAVEN, Conn., Nov. 06, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a... Read More

NEW HAVEN, Conn., Oct. 31, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it will release its third quarter 2023 financial results on Tuesday, November 14, 2023 before the open of the U.S. financial markets. BioXcel Therapeutics’ management team will also host a... Read More

Standardizes and improves product reimbursement process New HCPCS Level II code J1105 to be effective January 1, 2024 NEW HAVEN, Conn., Oct. 30, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that the Centers for Medicare & Medicaid Services (CMS) has issued a permanent and... Read More

No evidence of misconduct or fraud found beyond instance previously reported 1 No findings identified that impact data integrity Company believes audit findings support reliability of positive TRANQUILITY II trial data and potential sNDA submission NEW HAVEN, Conn., Oct. 25, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop... Read More

Median overall survival of 13.6 months with BXCL701 + KEYTRUDA® (pembrolizumab), compared to 7.6 months with checkpoint inhibitor monotherapy (CPI) in late-line refractory patients in separate, Phase 2 trial 1 56% of studied patients alive at one year following treatment with BXCL701 + KEYTRUDA®, compared to ~33% with checkpoint inhibitor monotherapy (CPI) in late-line refractory patients in separate, Phase 2 trial 1 Results... Read More

Meetings scheduled with FDA in October and November for TRANQUILITY and SERENITY III programs Company strengthens IGALMI ™ market exclusivity through receipt of two Notices of Allowance NEW HAVEN, Conn., Oct. 04, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience, today provided an... Read More

Business to prioritize high-potential agitation market opportunities for BXCL501 in bipolar disorders, schizophrenia, and Alzheimer’s disease Commercial reprioritization intended to reduce related expenses by 80% with focus on market access through contracting with large hospital systems (IDNs) Requested meeting with FDA to discuss TRANQUILITY II, audit plan, and data package to support potential submission of sNDA for... Read More

NEW HAVEN, Conn., July 31, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its second quarter 2023 financial results on Monday, August 14, 2023 before the open of the U.S. financial markets. BioXcel Therapeutics’ management... Read More

Trial met primary endpoint with the 60 mcg dose, with BXCL501 demonstrating a statistically significant 39% greater reduction in PEC score from baseline compared to placebo at 2 hours (p=0.0112) Met key secondary endpoint with statistically significant reduction (p=0.0185) in agitation symptoms versus placebo, as measured by PEC score change from baseline at 1 hour with 60 mcg dose; multiple secondary measures support... Read More

NEW HAVEN, Conn., June 01, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, will participate in fireside chats at two upcoming investor conferences. He will be joined by Robert Risinger, M.D.,... Read More

Clinically meaningful efficacy results observed with half (60mcg) of the approved dose of IGALMI™ Greater than 50% PEC response rate attained; proportionally consistent with dose response when compared to rates seen in SERENITY I and II BXCL501 was well tolerated and demonstrated favorable safety results supporting potential for at-home use SERENITY III Part 2 planned as an adaptive trial design with 60mcg and 80mcg to... Read More

BXCL501 was well tolerated across a broad dose range from 30mcg to 140mcg administered chronically Planning Phase 2 human proof-of-concept study to evaluate BXCL501 as a potential adjunctive treatment in MDD Data further supportive of ongoing clinical programs evaluating BXCL501 for potential at-home use for agitation associated with schizophrenia or bipolar disorders (SERENITY III) and agitation associated with Alzheimer’s... Read More

IGALMI™ (dexmedetomidine) commercial momentum accelerating with doubling of formulary wins, unlocking more than $55 million in targeted market opportunity, and an additional $255 million scheduled to vote Top-line data from pivotal SERENITY III Phase 3 trial (Part 1) for BXCL501 in bipolar or schizophrenia-associated agitation for at-home use expected in May 2023 Top-line data from repeat dosing of BXCL501 in Phase 1b trial... Read More

NEW HAVEN, Conn., May 02, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, will participate in a fireside chat at the BofA Securities 2023 Health Care Conference in Las Vegas on Tuesday, May 9,... Read More

NEW HAVEN, Conn., April 24, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its first quarter 2023 financial results on Monday, May 8, 2023 before the open of the U.S. financial markets. BioXcel Therapeutics’ management team... Read More

NEW HAVEN, Conn., March 14, 2023 (GLOBE NEWSWIRE) -- OnkosXcel Therapeutics, LLC (“OnkosXcel”) today announced that it has confidentially submitted a draft registration statement on Form S-1 with the Securities and Exchange Commission (the “SEC”) relating to the proposed initial public offering of its common stock following its conversion into a corporation. The number of shares to be offered and the price range for the... Read More

IGALMI™ (dexmedetomidine) commercial execution fully underway in 2023 with key focus on market access and demand generation through expanded field team Multiple pivotal data readouts for BXCL501 expected in Q2 2023 in disease areas with 139 million agitation episodes, 1- 3 * including Alzheimer’s-related agitation Positive data for BXCL701 in small cell neuroendocrine metastatic castration-resistant prostate cancer (SCNC)... Read More

NEW HAVEN, Conn., Feb. 23, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its fourth quarter and full year 2022 financial results on Thursday, March 9, 2023 before the open of the U.S. financial markets. BioXcel... Read More

NEW HAVEN, Conn., Feb. 21, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, additional members of the management team, and other BioXcel team members will ring the closing bell of the Nasdaq... Read More

BXCL701 plus KEYTRUDA® (pembrolizumab) demonstrated composite response rate of 25% in patients with metastatic SCNC-variant castration-resistant prostate cancer Company plans to initiate randomized trial evaluating BXCL701 plus pembrolizumab versus BXCL701 monotherapy NEW HAVEN, Conn., Feb. 13, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence... Read More

NEW HAVEN, Conn., Feb. 08, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will host a Key Opinion Leader (KOL) Day focused on its lead immuno-oncology program BXCL701 for the investment community on Tuesday, February 21, 2023 from 1:00... Read More

Results demonstrate encouraging response rate of BXCL701 plus KEYTRUDA ® (pembrolizumab) in patients with SCNC Full data will be presented at the 2023 ASCO Genitourinary Cancers Symposium in February NEW HAVEN, Conn., Jan. 11, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and... Read More

NEW HAVEN, Conn., Dec. 22, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, will present corporate updates and anticipated milestones for 2023 at the 41 st Annual J.P. Morgan Healthcare... Read More

Pivotal trial will evaluate efficacy and safety of BXCL501 in Alzheimer’s patients in nursing homes with moderate to severe dementia Estimated 100 million annual Alzheimer’s-related agitation episodes 1 could potentially increase current U.S. market opportunity for BXCL501 by more than six-fold 2 -4 TRANQUILITY II enrollment on track, with top-line data anticipated in 1H 2023 NEW HAVEN, Conn., Dec. 19, 2022 (GLOBE NEWSWIRE)... Read More

SERENITY III will evaluate the efficacy and safety of BXCL501 for at-home use Top-line pivotal data expected in 1H 2023 Estimated 23 million annual agitation episodes in the home-setting would more than double current market opportunity for BXCL501 in the U.S. 1 -4 NEW HAVEN, Conn., Nov. 30, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence... Read More