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. |
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
424B5 - BioXcel Therapeutics, Inc. (0001720893) (Filer)
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
10-Q - BioXcel Therapeutics, Inc. (0001720893) (Filer)
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
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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4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
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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)
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BXCL501 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 BXCL501 compared to placebo across agitation episode severity (p<.0001) BXCL501 showed a similar reduction in agitation symptoms over both the duration of the trial and number of treated episodes, demonstrating continued effects and consistent benefit with repeat dosing of BXCL501 Based on the large body of evidence and positive FDA feedback, Company plans to submit a sNDA in Q1 2026 for expanded usage of IGALMI® in the outpatient setting Company to host virtual KOL call with Dr.
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: HERE The live and archived webcast will also be available on the Events & Presentations page in the investors section of the Company's website. About BioXcel Therapeutics, Inc.BioXcel Therapeutics, Inc. (NASDAQ:
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
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 data from the SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, the Company's proprietary, sublingual film formulation of dexmedetomidine, as an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting. The data will be disseminated in a morning press release and presented during the investor call
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 trial for acute treatment of agitation associated with bipolar disorders or schizophrenia. Topline results from the study are expected in August. "The database lock is a significant step forward, and we are thrilled to have reached this critical milestone in an efficient manner as w
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
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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 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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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