BTAI - Earnings announcements

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 Following previously disclosed positive FDA feedback, BioXcel plans to submit a sNDA in Q1 2026 for expanded usage of BXCL501 in the outpatient setting without the supervision of a healthcare provider More than 2400 episodes of agitation were treated in the SERENITY At-Home

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 Following previously disclosed positive FDA feedback, BioXcel plans to submit a sNDA in Q1 2026 for expanded usage of BXCL501 in the outpatient setting without the supervision of a healthcare provider More than 2400 episodes of agitation were treated in the SERENITY

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., March 27, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today reported its financial results for the fourth quarter and full year 2

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 financial results for the third quarter of 2024. "Our focus continues to be the clinical development of BXCL501," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "We are advancing our SERENITY At-Home trial to pursue the near-term growth opportunity for t

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 call and webcast at 8:00 AM ET that day to discuss these results and provide a general business update. Conference Call and Webcast DetailsDate/Time:Thursday, November 14, 2024, at 8:00 AM ETParticipant Dial-In:877-407-5795 / 201-689-8722  The webcast link will be accessibl

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, Conn., Aug. 06, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative me

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 a conference call and webcast at 8:00 AM ET that day to discuss these results and provide a general business update. Conference Call and Webcast DetailsDate/Time:Tuesday, August 6, 2024, at 8:00 AM ETParticipant Dial-In:877-407-5795 / +1 201-689-8722   The webcast

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 medicines in neuroscience and immuno-oncology, today announced preliminary estimated unaudited net revenue results from sales of IGALMI™ (dexmedetomidine) sublingual film for the second quarter ended June 30, 2024. The Company expects unaudited revenue of appro

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 also host a conference call and webcast at 8:00 AM ET that day to discuss the Company's financial results and provide a general business update. Conference Call & Webcast Details      Date/Time:Participant Dial-In: Thursday, May 9, 2024, at 8:00 AM ET877-407-5795 / 201-689-

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 develop transformative medicines in neuroscience and immuno-oncology, today provided an update on its late-stage TRANQUILITY and SERENITY clinical programs. In addition, the Company reported its financial results for the fourth quarter and full year 2023. "We believe our l

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' management team will also host a conference call and webcast at 8:00 AM ET that day to discuss the Company's financial results and provide a general business update. Conference Call & Webcast Details  Date/Time:Tues., March 12, 2024, at 8:00 AM ETDomestic:877-407-5795Interna

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 conference call and webcast at 8:00 AM ET that day to discuss the Company's financial results and to provide a general business update. Conference Call & Webcast Details  Date/Time:Tuesday, November 14, 2023, at 8:00 AM Eastern TimeDomestic:877-407-5795International:201-689-8722

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 trial1 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 trial1 Results support potential development in small cell lung cancer (SCLC) and other neuroendocrine tumors Company to host conference call and webcast today at 8:00 a.m. ET NEW HAVEN, Conn., Oct. 10, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTA

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 BXCL501 in patients with agitation associated with mild to moderate dementia due to probable Alzheimer's disease SERENITY III Phase 3 trial (part 2) protocol amendment in process to evaluate BXCL501 80 mcg dose for at-home use in bipolar disorder or schizophrenia agit

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 team will also host a conference call and webcast at 8:00 AM ET that day to discuss the Company's financial results and to provide a general business update. Conference Call & Webcast Details  Date/Time:Monday, August 14, 2023 at 8:00 AM Eastern TimeDomestic:877-407-5795

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 efficacy 443 episodes for 149 patients were treated over 12 weeks across all doses; dosing with 60 mcg showed a similar reduction in agitation for first and all treated episodes at 1 and 2 hours, as measured by average change in PEC score   BXCL501 was well tolerated with n

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 potentially address agitation spectrum for patients at home Company to hold conference today at 8 a.m. ET  NEW HAVEN, Conn., May 25, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence approa

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 for Major Depressive Disorder program in healthy volunteers expected in May 2023 Top-line data from pivotal TRANQUILITY II Phase 3 trial for BXCL501 for acute treatment of agitation associated with Alzheimer's disease expected in June 2023 Company to host conference

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 will also host a conference call and webcast at 8:00 AM ET that day to discuss the Company's financial results and to provide a general business update. Conference Call & Webcast Details  Date/Time:Monday, May 8, 2023 at 8:00 AM Eastern TimeDomestic:877-407-5795Internati

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) further validates Company's AI drug discovery and development expertise; Company exploring strategic options for OnkosXcel subsidiary Company to host conference call at 8:30 a.m. ET today NEW HAVEN, Conn., March 09, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics,

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 Therapeutics' management team will also host a conference call and webcast at 8:30 AM ET to discuss the Company's financial results and to provide a general business update. Conference Call & Webcast DetailsDate/Time:Domestic:International:Thursday, March 9, 2023 at 8:30 AM Eastern

IGALMI™ (dexmedetomidine) well-positioned for growth in 2023 based on increasing market access, efficient targeting, favorable market drivers, and sales force expansion in all major U.S. geographies Top-line pivotal data for TRANQUILITY II trial investigating BXCL501 for Alzheimer's-related agitation expected in 1H 2023 Top-line pivotal data for SERENITY III trial investigating at-home use of BXCL501 for acute treatment of bipolar and schizophrenia-related agitation expected in 1H 2023 Completed multiple, seven-day daily dosing regimen cohorts in ongoing Phase 1 dose-selection trial in healthy volunteers to assess Major Depressive Disorder (MDD) program for at-home use; top-line results e

NEW HAVEN, Conn., Oct. 27, 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 it will release its third quarter 2022 financial results on Thursday, November 10, 2022 before the open of the U.S. financial markets. BioXcel Therapeutics' management team will also host a conference call and webcast at 8:30 AM ET to discuss the Company's financial results and to provide a general business update. Conference Call & Webcast DetailsDate/Time:Domestic:International:Thursday, November 10, 2022 at 8:30 AM Eastern Time877

Commercially launched IGALMI™ (dexmedetomidine) sublingual film for the acute treatment of agitation in bipolar I or II disorder and schizophrenia in adult patients SERENITY III pivotal trial evaluating at-home use of BXCL501 for the acute treatment of agitation in bipolar and schizophrenia patients planned to initiate in 2H 2022 following recent Type B meeting with FDA Top-line data from TRANQUILITY II pivotal trial for agitation associated with Alzheimer's disease expected in 1H 2023; TRANQUILITY III enrollment initiating in 2H 2022 Top-line results from ongoing Phase 1 Major Depressive Disorder dose-selection trial in healthy volunteers expected in 1H 2023; C

NEW HAVEN, Conn., July 26, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its second quarter 2022 financial results on Tuesday, August 9, 2022 before the open of the U.S. financial markets. BioXcel Therapeutics' management team will also host a conference call and webcast at 8:30 AM ET to discuss the Company's financial results and to provide a general business update. Conference Call & Webcast DetailsDate/Time:Domestic:International:Tuesday, August 9, 2022 at 8:30 AM Easte

Received FDA approval of IGALMI™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults Top-line data readout in Q4 2022/early Q1 2023 for TRANQUILITY II Phase 3 trial evaluating BXCL501 in acute treatment of agitation associated with Alzheimer's disease Extended cash runway into 2025 with $260 million strategic financing for IGALMI commercial launch and clinical and regulatory milestones U.S. national salesforce deployment to commence on May 23, 2022 To host conference call today, May 9, 2022, at 8:30 a.m. ET NEW HAVEN, Conn., May 09, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a c

NEW HAVEN, Conn., April 26, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence (AI) approaches to identify and develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its first quarter 2022 financial results on Monday, May 9, 2022 before the open of the U.S. financial markets. BioXcel Therapeutics' management team will also host a conference call and webcast at 8:30 AM ET to discuss the Company's financial results and to provide a general business update. Conference Call & Webcast DetailsDate/Time:Domestic:International:Monday, May 9, 2022 at 8:3

First and only FDA-approved orally dissolving sublingual film for mild, moderate or severe agitation in patients with schizophrenia or bipolar I or II disorder1 IGALMI demonstrated onset of action as early as 20 minutes and high response rate with both 120 mcg and 180 mcg doses in pivotal studies1 Up to 25 million agitation episodes for these two patient populations in the U.S. annually2-3 U.S. commercial launch planned for Q2 2022 Company to host investor conference call on April 6, 2022 at 8:30 a.m. ET NEW HAVEN, Conn., April 06, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence (AI) a

Ready to launch BXCL501 upon approval as Company nears April 5, 2022 PDUFA action date Initiated TRANQUILITY II AND III pivotal Phase 3 trials for BXCL501 in acute treatment of agitation associated with Alzheimer's disease Submitted IND to evaluate BXCL501 as adjunctive treatment for major depressive disorder (MDD) Demonstrated encouraging composite response rates for BXCL701 in combination with KEYTRUDA® for mCRPC in SCNC and adenocarcinoma cohorts To host conference call today, March 10, 2022, at 8:30 a.m. ET NEW HAVEN, Conn., March 10, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence ap

NEW HAVEN, Conn., Feb. 24, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a clinical-stage 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 2021 financial results on Thursday, March 10, 2022 before the open of the U.S. financial markets. BioXcel Therapeutics' management team will also host a conference call and webcast at 8:30 AM ET to discuss the Company's financial results and to provide a general business update. Conference Call & Webcast Details  Date/Time:Thursday, March 10, 2022 at 8:30 AM Eastern Time

Plans for commercial and launch readiness advancing for BXCL501 orally dissolving film, for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, ahead of January 5, 2022 PDUFA date On track to initiate Phase 3 program for acute treatment of agitation in patients with Alzheimer's disease in Q4 2021 Strengthened neuroscience franchise with indication expansion for BXCL501 in major depressive disorder (MDD) Introduced BXCL502 candidate for chronic agitation in dementia, identified through Company's artificial intelligence platform Demonstrated encouraging anti-tumor activity and favorable safety profile for BXCL701 in combination with KEYTRUDA® in

NEW HAVEN, Conn., Oct. 27, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its third quarter 2021 financial results on Wednesday, November 10, 2021 before the open of the U.S. financial markets. BioXcel Therapeutics' management team will also host a conference call and webcast at 8:30 AM ET to discuss the Company's financial results and to provide a general business update. Conference Call & Webcast DetailsDate/Time:Domestic:International:Wednesday, November 10, 2021 at 8:30 A

NEW HAVEN, Conn., July 28, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced it will release its second quarter 2021 financial results on Tuesday, August 10, 2021 before the open of the U.S. financial markets. BioXcel's management team will also host a conference call and webcast at 8:30 AM EDT to discuss the Company's financial results and to provide a general business update. Conference Call & Webcast DetailsDate/Time:Domestic:International:Tuesday, August 10, 2021