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BioXcel Therapeutics Reports Positive Topline Exploratory Efficacy Dat...
BioXcel Therapeutics Reports Positive Topline Exploratory Efficacy Data from SERENITY At-Home Pivotal Phase 3 Safety Trial for Agitation Associated with Bipolar Disorders or Schizophrenia BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p
BioXcel Therapeutics to Present at the H.C. Wainwright 27th Annual Glo...
BioXcel Therapeutics to Present at the H.C. Wainwright 27th Annual Global Investment Conference 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 27th Annual Global Investment Conference to be held September 8 - 10, 2025. Date: Monday, September 8, 2025Time: 4:30 p.m. Eastern TimeWebcast Link: The live an...
UPDATE -- BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phas...
UPDATE -- 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® 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 ...
BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety...
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® 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 Fol...
BioXcel Therapeutics To Announce Topline Results from SERENITY At-Home...
BioXcel 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, 2025 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 da...
BioXcel Therapeutics Announces Database Lock in SERENITY At-Home Pivot...
BioXcel Therapeutics Announces Database Lock in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia 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 tr...
BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments ...
BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia 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 respo...
BioXcel Therapeutics to Participate in the H.C. Wainwright & Co. “HCW@...
BioXcel Therapeutics to Participate in the H.C. Wainwright & Co. “HCW@Home” Series 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. Date: Tuesday, August 14, 2025Time: 1 p.m. Eastern TimeWebcast Link: About BioXcel T...
BioXcel Therapeutics Reports Second Quarter 2025 Financial Results and...
BioXcel Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Updates 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 Therapeutics strengthens cash position NEW HAVEN, Conn., Aug. 12, 2025 ...
BioXcel Therapeutics to Participate in Canaccord Genuity 45th Annual G...
BioXcel Therapeutics to Participate in Canaccord Genuity 45th Annual Growth Conference 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 access a webcast of the fireside chat, please visit the under the “News/Events...
BioXcel Therapeutics Announces Publication in Frontiers in Pharmacolog...
BioXcel 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 Studies 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. (Nasd...
BioXcel Therapeutics Announces Last Patient Last Visit in SERENITY At-...
BioXcel 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 Schizophrenia 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 ...
BioXcel Therapeutics Submits Pre-Supplemental New Drug Application Mee...
BioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package in Support of Potential Label Expansion for IGALMI® 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 transformative medicines in neuroscienc...
e-therapeutics sécurise le développement clinique de son candidat GalO...
e-therapeutics sécurise le développement clinique de son candidat GalOmic ETX-312 grâce à des données non cliniques positives ETX-312 bien toléré à des doses élevées lors d’études de toxicologie conformes aux normes BPL Fabrication du lot destiné à l’essai clinique achevée avec succès conformément aux normes BPF Soumission de la demande d’autorisation d’essai clinique en bonne voie pour le quatrième trimestre 2025 LONDRES, 11 juill. 2025 (GLOBE NEWSWIRE) -- e-therapeutics plc, une entreprise qui allie la puissance informatique aux données biologiques en vue de mettre au point de nouvea...
e-therapeutics reduziert Risiken im klinischen Verfahren für GalOmic-K...
e-therapeutics reduziert Risiken im klinischen Verfahren für GalOmic-Kandidaten ETX-312 dank positiver Ergebnisse in der vorklinischen Phase ETX-312 wurde in GLP-konformen Toxikologiestudien in überhöhten Dosierungen gut vertragen GMP-konforme Herstellung einer Charge für klinische Studien erfolgreich abgeschlossen Auf Kurs für die Einreichung bei der CTA im vierten Quartal 2025 LONDON, July 11, 2025 (GLOBE NEWSWIRE) -- e-therapeutics plc, ein Unternehmen, das Rechenleistung und biologische Daten integriert, um lebensverändernde RNAi-Medikamente zu entdecken, gab heute bedeutende...
e-therapeutics De-risks Clinical Path for GalOmic Candidate ETX-312 wi...
e-therapeutics De-risks Clinical Path for GalOmic Candidate ETX-312 with Positive Non-clinical Data ETX-312 well tolerated at exaggerated dose levels in GLP-compliant toxicology studies GMP manufacturing of clinical trial batch successfully completed On track for CTA submission in Q4 2025 LONDON, July 10, 2025 (GLOBE NEWSWIRE) -- e-therapeutics plc, a company integrating computational power and biological data to discover life-transforming RNAi medicines, today announced significant progress on its lead candidate, ETX-312, a GalOmic siRNA therapy for the treatment of metabolic dy...
BioXcel Therapeutics Receives Second Positive Recommendation from Data...
BioXcel 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 Schizophrenia 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 recommendati...
BioXcel Therapeutics Receives Positive Recommendation from Data Safety...
BioXcel 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 Schizophrenia 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...
BioXcel Therapeutics Granted Extension to Regain Compliance with Nasda...
BioXcel Therapeutics Granted Extension to Regain Compliance with Nasdaq Continued Listing Requirement 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 and strategies to regain compliance with Listing Rule 5550(b)(2...
BioXcel Therapeutics Reports First Quarter 2025 Financial Results and ...
BioXcel Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update 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 utilizing artificial intelligence to develop transformative medicines in n...
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