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| 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 |
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 transformative medicines in neuroscience, today announced it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home
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 medicines in neuroscience, today announced the advancement of its commercial planning for IGALMI® in the at-home setting. As part of this, Mark Pavao, a commercial planning and launch advisor with more than 3
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 seeking the U.S. Food and Drug Administration's (FDA) approval of IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. "We are pleased with the progress towards submission of the sNDA and launch planning," said Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics. "Based on the accelerated submission timeline, we
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
4 - BioXcel Therapeutics, Inc. (0001720893) (Issuer)
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
8-K - BioXcel Therapeutics, Inc. (0001720893) (Filer)
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
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
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
SC 13G/A - BioXcel Therapeutics, Inc. (0001720893) (Subject)
SC 13D/A - BioXcel Therapeutics, Inc. (0001720893) (Subject)
SC 13G/A - BioXcel Therapeutics, Inc. (0001720893) (Subject)
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 medicines in neuroscience, today announced the advancement of its commercial planning for IGALMI® in the at-home setting. As part of this, Mark Pavao, a commercial planning and launch advisor with more than 3
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