$BTAI News
Last published 2mo ago
- 2mo agoBTAIBioXcel Therapeutics Enters Into Asset Sale Agreement with Teva PharmaceuticalsGlobeNewswireBioXcel Therapeutics intends to complete a court-supervised sale transaction, in an effort to maximize value for all stakeholders Teva Pharmaceuticals to serve as "stalking horse" bidder in a court-supervised
- 5mo agoBTAIBioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual MeetingGlobeNewswireNEW HAVEN, Conn., May 28, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company built on artificial intelligence ("AI") to develop transformative medicines in neuroscience,
- 6mo agoBTAIBioXcel Therapeutics Provides Business Update and Reports First Quarter 2026 Financial ResultsGlobeNewswireFDA accepted sNDA for IGALMI® use in at-home (outpatient) setting; set Nov. 14, 2026, as PDUFA date Advancing BXCL501 as a potential acute treatment for agitation associated with Alzheimer's dementia
- 6mo agoBTAIBioXcel Therapeutics Announces Virtual Event to Discuss Commercial Launch Plan Based on Market Opportunity Assessment for IGALMI® in the At-Home SettingGlobeNewswireLive event to be held on Thursday, April 23, at 2:00 p.m. ET Company focused on advancing launch strategy ahead of November 14 PDUFA target action date NEW HAVEN, Conn., April 17, 2026 (GLOBE NEWSWIRE) -- BioXcel
- 7mo agoBTAIBioXcel Therapeutics Announces Enrollment of First Patients in U.S. Department of War-Funded Study of BXCL501 (Sublingual Dexmedetomidine) for Treatment of Acute Stress ReactionsGlobeNewswireDoW-funded Phase 2a trial led by University of North Carolina at Chapel Hill (UNC) Institute for Trauma Recovery Positive outcomes from trial can potentially impact Veteran Affairs/Department of War Clinical Practice
- 7mo agoBTAIBioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI® in the At-Home SettingGlobeNewswirePDUFA target action date of November 14, 2026 Potential first FDA-approved treatment option for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting
- 7mo agoBTAIBioXcel Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results as Company Prepares for Potential IGALMI® Approval in Outpatient SettingGlobeNewswiresNDA submitted seeking approval of IGALMI® in the at-home (outpatient) setting for the treatment of acute agitation associated with bipolar disorders or schizophrenia sNDA submission timeline supports potential
- 8mo agoBTAIBioXcel Therapeutics Announces Approximately $8.0 Million Registered Direct OfferingGlobeNewswireNEW HAVEN, Conn., March 10, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the "Company") (NASDAQ:BTAI), a biopharmaceutical company built on artificial intelligence to develop transformative medicines in
- 8mo agoBTAIBioXcel Therapeutics Announces Positive Phase 2 Topline Results from Columbia University-Led Study of BXCL501 for Treatment of Opioid WithdrawalGlobeNewswireBXCL501 demonstrated clinical benefits and favorable tolerability profile for treatment of opioid withdrawal symptoms Results from this NIDA-funded study support potential future development of BXCL501 in opioid
- 8mo agoBTAIBioXcel Therapeutics KOL Virtual Roundtable Day - BIOXCEL THERAPEUTICS INCEarnings Call TranscriptsGreetings and welcome to the BioXL Therapeutics KOL Virtual Roundtable Day. At this time, participants are on listen-only mode. You can submit your questions by typing them in the Ask a Question field on the bottom of yo
- 8mo agoBTAIBioXcel Therapeutics to Host Virtual Roundtable Featuring Leading Medical Experts Addressing Latest Developments in Treatment of Acute Agitation in Alzheimer's DementiaGlobeNewswireDiscussion will focus on the high unmet need and the lack of FDA-approved treatment options associated with acute agitation episodes in Alzheimer's dementia Large patient population affected by Alzheimer's agitation,
- 9mo agoBTAIBioXcel Therapeutics Completes Market Opportunity Assessment and Advances Commercialization Plans for IGALMI® in the At-Home SettingGlobeNewswireThird party commercial assessment shows larger than expected potential total addressable market for IGALMI® in the at-home setting Strong prescriber interest, patient demand, and positive payer feedback on
- 9mo agoBTAIBioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home SettingGlobeNewswiresNDA submission supports the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI® Submission timeline supports potential approval of
- 10mo agoBTAIBioXcel Therapeutics Expands Leadership Team to Prepare for Launch of IGALMI® in the At-Home SettingGlobeNewswireMark Pavao to Join BioXcel Therapeutics as Interim Chief Commercial Officer Mr. Pavao Brings Deep Experience in Neuroscience Sales and Marketing to Support Potential Launch of IGALMI® in At-Home Setting as Early as
- 10mo agoBTAIBioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®GlobeNewswireNEW HAVEN, Conn., Jan. 07, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company built on artificial intelligence ("AI") to develop transformative medicines in neuroscience,
- 11mo agoBTAIBioXcel Therapeutics - BIOXCEL THERAPEUTICS INCEarnings Call TranscriptsGood morning everyone and thank you for joining us today. I would like to start by welcoming our distinguished participants. We are grateful to each of you for bringing your deep experience in the agitation space to help
- 11mo agoBTAIAward-Winning Journalist Anjalee Khemlani to Host Virtual Roundtable with Leading Medical Experts to Discuss Latest Developments in Treating Acute Agitation Related to Neuropsychiatric ConditionsGlobeNewswireEvent Sponsored by BioXcel Therapeutics Set for 10 a.m. EST on Monday, Dec. 8 Topics Covered by Drs. Leslie Citrome, Marc Milano, and Leon Ravin to Include Opportunities and Advantages of Self-Administered Treatments at
- 11mo agoBTAIApproval of Igalmi, Nda #215390 (Efficacy)FDA Approved DrugsApproval Date: 11/19/2025; Drug Name: Igalmi, Nda #215390; Active Ingredients: DEXMEDETOMIDINE HYDROCHLORIDE; Company: Bioxcel; Submission Status: Approval; Submission Classification: Efficacy; Application Number: 215390
- 1y agoBTAIBioXcel Therapeutics Reports Third Quarter 2025 Financial Results and Provides Update on Late-Stage Clinical Programs for Agitation in Bipolar, Schizophrenia, and Alzheimer's DiseaseGlobeNewswireNEW HAVEN, Conn., Nov. 12, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today
- 1y agoBTAIBioXcel Therapeutics Announces Positive Results from Correlation Study Supporting SERENITY At-Home Exploratory Efficacy OutcomesGlobeNewswireNEW 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
- 1y agoBTAIBioXcel Therapeutics to Ring Nasdaq Closing Bell on October 14 to Celebrate a Transformative Milestone in Neuroscience InnovationGlobeNewswireNEW 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
- 1y agoBTAIBioXcel Therapeutics Regains Compliance with Nasdaq Market Value of Listed Securities RequirementsGlobeNewswireNEW 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
- 1y agoBTAIBioXcel Therapeutics, Inc. (BTAI) Discuses On SERENITY At-Home Pivotal Phase 3 Safety Trial Results Call (Transcript)Earnings Call Transcripts
- 1y agoBTAIBioXcel Therapeutics Reports Positive Topline Exploratory Efficacy Data from SERENITY At-Home Pivotal Phase 3 Safety Trial for Agitation Associated with Bipolar Disorders or SchizophreniaGlobeNewswireBXCL501 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
- 1y agoBTAIBioXcel Therapeutics to Present at the H.C. Wainwright 27th Annual Global Investment ConferenceGlobeNewswireNEW 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
- 1y agoBTAIUPDATE -- BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®GlobeNewswireBXCL501 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
- 1y agoBTAIBioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®GlobeNewswireBXCL501 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
- 1y agoBTAIBioXcel Therapeutics To Announce Topline Results from SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia on August 27, 2025GlobeNewswireNEW 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
- 1y agoBTAIBioXcel Therapeutics Announces Database Lock in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or SchizophreniaGlobeNewswireData 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
- 1y agoBTAIBioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or SchizophreniaGlobeNewswireAchieved 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
- 1y agoBTAIBioXcel Therapeutics to Participate in the H.C. Wainwright & Co. "HCW@Home" SeriesGlobeNewswireNEW 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
- 1y agoBTAIBioXcel Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business UpdatesGlobeNewswireTopline 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
- 1y agoBTAIBioXcel Therapeutics to Participate in Canaccord Genuity 45th Annual Growth ConferenceGlobeNewswireNEW 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
- 1y agoBTAIBioXcel Therapeutics Announces Publication in Frontiers in Pharmacology on the Effects of Dexmedetomidine (the active ingredient in BXCL-501) on Stress-Mediated Behaviors in Non-clinical StudiesGlobeNewswireDexmedetomidine 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
- 1y agoBTAIBioXcel Therapeutics Announces Last Patient Last Visit in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or SchizophreniaGlobeNewswireVast 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,
- 1y agoBTAIBioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package in Support of Potential Label Expansion for IGALMI®GlobeNewswireCompany 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
- 1y agoBTAIBioXcel Therapeutics Receives Second Positive Recommendation from Data Safety Monitoring Board (DSMB) to Continue SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or SchizophreniaGlobeNewswireDSMB 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
- 1y agoTEMBTAIReal-World Deployments Signal AI Healthcare Is Ready for ScalePR NewswireThe concept of AI in healthcare is no longer a novelty, experts are acknowledging AI algorithms, detection, and drug discovery are becoming...
- 1y agoBTAIBioXcel Therapeutics Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) to Continue SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or SchizophreniaGlobeNewswireDSMB 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
- 1y agoBTAIBioXcel Therapeutics Granted Extension to Regain Compliance with Nasdaq Continued Listing RequirementGlobeNewswireNEW 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
- 1y agoBTAIBioXcel Therapeutics Reports First Quarter 2025 Financial Results and Provides Business UpdateGlobeNewswireEnrollment 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
- 1y agoBTAITVGNAMSTPLTRWHO and WEF Are Pushing AI in Global Healthcare -- What It Means for the MarketPR NewswireEquity Insider News Commentary – The potential for artificial intelligence (AI) in healthcare is still unfolding, both for patients and providers. A...
- 1y agoBTAIBioXcel Therapeutics Reports Financial Results for the Fourth Quarter and Full Year 2024GlobeNewswireEnrollment 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
- 1y agoBTAIBioXcel Therapeutics Strengthens Cash Position to Advance SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or SchizophreniaGlobeNewswireTopline 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
- 1y agoBTAIBioXcel Therapeutics Announces 33% Enrollment in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or SchizophreniaGlobeNewswireData 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) --
- 1y agoBTAIBioXcel Therapeutics Announces Closing of $14 Million Registered Direct OfferingGlobeNewswireNEW 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
- 1y agoBTAIBioXcel Therapeutics Announces $14 Million Registered Direct OfferingGlobeNewswireNEW 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
- 1y agoBTAIBioXcel Therapeutics Announces FDA Closed its Inspection of Site for Phase 3 TRANQUILITY II Trial for Acute Treatment of Agitation Associated with Alzheimer's DementiaGlobeNewswireFDA 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
- 1y agoBTAIBioXcel Therapeutics Regains Compliance with Nasdaq Minimum Bid Price RuleGlobeNewswireNEW 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
- 1y agoBTAIBioXcel Therapeutics Announces Reverse Stock SplitGlobeNewswireNEW 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