BioXcel Therapeutics, Inc., a clinical stage biopharmaceutical company, focuses on artificial intelligence-based drug development in the fields of neuroscience and immuno-oncology in the United States. The company is involved in developing BXCL501, a sublingual thin film formulation of adrenergic receptor agonist dexmedetomidine for the treatment of agitation resulting from neurological and psychiatric disorders; and BXCL701, an immune activator for the treatment of prostate and pancreatic cancers, and solid tumors. BioXcel Therapeutics, Inc. has a collaboration with collaboration with the VA Connecticut Healthcare System and the Yale University Medical School for patients suffering from post-traumatic stress disorder related to alcohol and substance abuse disorder. The company was incorporated in 2017 and is headquartered in New Haven, Connecticut.
IPO Year: 2018
Exchange: NASDAQ
Website: bioxceltherapeutics.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 2/21/2024 | $9.00 → $4.00 | Buy → Neutral | UBS |
| 8/15/2023 | $40.00 → $4.00 | Buy → Neutral | Mizuho |
| 7/17/2023 | Buy → Neutral | Guggenheim | |
| 3/10/2023 | $20.00 → $22.00 | Buy → Hold | Jefferies |
| 12/1/2022 | $16.00 | Sell → Neutral | Goldman |
| 7/7/2022 | $19.00 | Buy | Mizuho |
| 4/6/2022 | $80.00 | Buy | BofA Securities |
| 2/16/2022 | $88.00 → $25.00 | Buy | UBS |
| 11/15/2021 | $55.00 → $24.00 | Buy → Sell | Goldman Sachs |
| 6/28/2021 | $176.00 → $140.00 | Buy | HC Wainwright & Co. |
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4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
Live FDA approvals issued by the Food and Drug Administration and FDA breaking news
Submission status for BIOXCEL THERAPEUTICS, INC.'s drug IGALMI (ORIG-1) with active ingredient DEXMEDETOMIDINE has changed to 'Approval' on 04/05/2022. Application Category: NDA, Application Number: 215390, Application Classification: Type 3 - New Dosage Form
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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 responses from the U.S. Food and Drug Administration (FDA). Based on the FDA's feedback, the Company believes that the planned sNDA regulatory package will be sufficient to support the sNDA submission, which remains on track for the first quarter of 2026. The primary purpos
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: Register here About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (NASDAQ:BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscienc
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 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today reported its f
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 Events & Presentations page under the "News/Events" tab in the Investors & Media section of the company's website at bioxceltherapeutics.com. A webcast replay will be available for 90 days. About BioXcel Ther
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. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced a publication in the peer-reviewed journal Frontiers in Pharmacology, entitled "Dexmedetomidine potently and reversibly regulates stress-mediated behaviors."
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 announced completion of the last patient last visit (LPLV) in the pivotal Phase 3 SERENITY At-Home clinical trial. Topline data from the study are expected to be released this month and are intended to support the planned supplemental New Drug Application (sNDA) to potentially expand the lab
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 neuroscience, today announced the submission of a pre-supplemental New Drug Application (pre-sNDA) meeting package to the U.S. Food and Drug Administration (FDA) for IGALMI® in support of a potential label expansion for outpatient use for the acute t
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 recommendation by an independent Data Safety Monitoring Board (DSMB) to continue, without modification, the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia. The DSMB recommendation followed a review of unblinded safety data from 178 patients dosed as of the May 28
Equity Insider News Commentary Issued on behalf of Avant Technologies Inc. VANCOUVER, BC, May 30, 2025 /PRNewswire/ -- The concept of AI in healthcare is no longer a novelty, experts are acknowledging AI algorithms, detection, and drug discovery are becoming indispensable tools. As medical errors continue to harm patients, healthcare experts are turning to AI to improve mistakes in medications, such as prescribing the wrong drug or wrong dose. As real-world deployment gains momentum, a number of tech and biotech firms are already translating AI healthcare innovation into clinical practice. Notable recent activity includes initiatives from Avant Technologies, Inc. (OTCQB:AVAI), Tempus AI, Inc
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 Monitoring Board (DSMB) recommended that the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia continue without modification. The DSMB recommendation followed a review of unblinded safety data from the first 115 patients dosed as of the May 2
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8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
424B5 - BioXcel Therapeutics, Inc. (0001720893) (Filer)
Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.
UBS downgraded BioXcel Therapeutics from Buy to Neutral and set a new price target of $4.00 from $9.00 previously
Mizuho downgraded BioXcel Therapeutics from Buy to Neutral and set a new price target of $4.00 from $40.00 previously
Guggenheim downgraded BioXcel Therapeutics from Buy to Neutral
Jefferies downgraded BioXcel Therapeutics from Buy to Hold and set a new price target of $22.00 from $20.00 previously
Goldman upgraded BioXcel Therapeutics from Sell to Neutral and set a new price target of $16.00
Mizuho initiated coverage of BioXcel Therapeutics with a rating of Buy and set a new price target of $19.00
BofA Securities reiterated coverage of BioXcel Therapeutics with a rating of Buy and set a new price target of $80.00
UBS reiterated coverage of BioXcel Therapeutics with a rating of Buy and set a new price target of $25.00 from $88.00 previously
Goldman Sachs downgraded BioXcel Therapeutics from Buy to Sell and set a new price target of $24.00 from $55.00 previously
HC Wainwright & Co. reiterated coverage of BioXcel Therapeutics with a rating of Buy and set a new price target of $140.00 from $176.00 previously
Live finance-specific insights
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
Live Leadership Updates
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, today announced a key executive promotion and a clinical advisor appointment as part of the Company's strategic reprioritization focused on the advancement of its late-stage clinical programs and emerging pipeline candidates. Vincent J. O'Neill, M.D., Senior Vice
NEW HAVEN, Conn., July 05, 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 the appointment of Michael P. Miller to its Board of Directors, effective July 1, 2022. Mr. Miller brings nearly 40 years of strategic leadership and commercial growth experience in the pharmaceutical industry, where he most recently served as Executive Vice President, U.S. Commercial at Jazz Pharmaceuticals. "We are pleased to welcome Mike to our Board and believe his deep commercial and market access expertise will be
NEW HAVEN, Conn., Jan. 19, 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 the appointment of Matt Wiley as Senior Vice President and Chief Commercial Officer (CCO). "We are pleased to welcome Matt to our management team, as we prepare for our first potential approval and commercial launch of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "With over 25 years of commercial and industry exper
NEW HAVEN, Conn., March 01, 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 the appointment of June Bray to its Board of Directors. Ms. Bray brings over forty years of extensive U.S. and global regulatory experience in the healthcare industry and most recently served as Senior Vice President, Global Regulatory Affairs and Medical Writing at Allergan. “June is a pharmaceutical industry veteran with a proven track record in leading successful regulatory activities for
NEW HAVEN, Conn., Feb. 23, 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 the appointment of Javier Rodriguez as Senior Vice President, Chief Legal Officer and Corporate Secretary, effective immediately. Mr. Rodriguez will report to Chief Executive Officer, Vimal Mehta and joins BioXcel with 20 years of extensive strategic and legal experience within the biopharmaceutical industry. “We are pleased to welcome Javier to BioXcel at this important time in our Company’s
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