reports
BioXcel Therapeutics Completes Market Opportunity Assessment and Advan...
BioXcel Therapeutics Completes Market Opportunity Assessment and Advances Commercialization Plans for IGALMI® in the At-Home Setting Third 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 formulary coverage NEW HAVEN, Conn., Feb. 12, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced th...
BioXcel Therapeutics Submits Supplemental New Drug Application to U.S....
BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting sNDA 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 IGALMI® label expansion as early as year-end 2026 NEW HAVEN, Conn., Jan. 20, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transform...
BioXcel Therapeutics Expands Leadership Team to Prepare for Launch of ...
BioXcel Therapeutics Expands Leadership Team to Prepare for Launch of IGALMI® in the At-Home Setting Mark 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 Year-End 2026 BioXcel Therapeutics on Track to Submit a sNDA for IGALMI® this Month NEW HAVEN, Conn., Jan. 12, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative med...
BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Ap...
BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI® Company remains focused on potential approval and launch of IGALMI® for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting NEW 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, today announced that it plans to submit a supplemental New Drug Application (sNDA) this month ...
Award-Winning Journalist Anjalee Khemlani to Host Virtual Roundtable w...
Award-Winning Journalist Anjalee Khemlani to Host Virtual Roundtable with Leading Medical Experts to Discuss Latest Developments in Treating Acute Agitation Related to Neuropsychiatric Conditions Event 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 Home NEW HAVEN, Conn., Dec. 03, 2025 (GLOBE NEWSWIRE) -- As millions of patients and caregivers continue to struggle with acute agitation episodes associated with bipolar disor...
BioXcel Therapeutics Reports Third Quarter 2025 Financial Results and ...
BioXcel Therapeutics Reports Third Quarter 2025 Financial Results and Provides Update on Late-Stage Clinical Programs for Agitation in Bipolar, Schizophrenia, and Alzheimer’s Disease sNDA submission expected in early Q1 2026 for expanded usage of IGALMI® in home setting based on positive data from the SERENITY At-Home trial NEW 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 reported financial results for the third quarter of...
BioXcel Therapeutics Announces Positive Results from Correlation Study...
BioXcel Therapeutics Announces Positive Results from Correlation Study Supporting SERENITY At-Home Exploratory Efficacy Outcomes 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 At-Home trial. The results, along w...
BioXcel Therapeutics to Ring Nasdaq Closing Bell on October 14 to Cele...
BioXcel Therapeutics to Ring Nasdaq Closing Bell on October 14 to Celebrate a Transformative Milestone in Neuroscience Innovation 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 — celebrating BioXcel’s breakthrough pr...
e-therapeutics relance son activité sous le nom de Tangram Therapeutic...
e-therapeutics relance son activité sous le nom de Tangram Therapeutics et présente LLibra OS Ce renouveau marque une étape décisive dans la croissance de la Société, qui prévoit de soumettre sa première demande d’essai clinique (ou CTA, de l’anglais « Clinical Trial Application ») au quatrième trimestre 2025. Présentation de LLibra OS, une plateforme d’IA de nouvelle génération visant à accélérer la découverte et l’évaluation de cibles génétiques différenciées et la conception de petits ARN interférents (siRNA, de l’anglais « small interfering RNA »). LONDRES, 02 oct. 2025 (GLOBE NEWSW...
e-therapeutics startet als Tangram Therapeutics neu und stellt LLibra ...
e-therapeutics startet als Tangram Therapeutics neu und stellt LLibra OS vor Der Relaunch markiert den entscheidenden nächsten Schritt für das Wachstum des Unternehmens – in Erwartung der ersten CTA-Einreichung im vierten Quartal 2025. Vorstellung von LLibra OS, einer KI-Plattform der nächsten Generation, die die Entdeckung und Bewertung differenzierter Gen-Targets und das siRNA-Design beschleunigt. LONDON, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Tangram Therapeutics (ehemals e-therapeutics), ein Unternehmen, das sich der Vereinigung von Computertechnologie und RNAi zur schnelleren Herstellun...
e-therapeutics Relaunches as Tangram Therapeutics and Unveils LLibra O...
e-therapeutics Relaunches as Tangram Therapeutics and Unveils LLibra OS Relaunch marks pivotal next step in the company’s growth, in anticipation of first CTA submission in Q4 2025. Introducing LLibra OS, a next-generation AI platform that accelerates discovery and evaluation of differentiated gene targets and siRNA design. LONDON, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Tangram Therapeutics (formerly e-therapeutics), a company committed to uniting computation and RNAi to make better medicines faster, today announced its corporate relaunch. Tangram Therapeutics is inspired by a geometric...
BioXcel Therapeutics Regains Compliance with Nasdaq Market Value of Li...
BioXcel Therapeutics Regains Compliance with Nasdaq Market Value of Listed Securities Requirements 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 securities (“MVLS”) requirement under Nasdaq Listing Rule 5550(b)(2) (the “...
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...
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