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