BioXcel Therapeutics Aligns with FDA Recommendation for Phase 3 Trial for TRANQUILITY Program, Provides Update on Strategic Financing, and Reports Third Quarter 2023 Financial Results
November 14, 2023 07:00 ET
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BioXcel Therapeutics
Company plans to conduct Phase 3 trial of BXCL501 in the at-home setting for TRANQUILITY program to support potential sNDA for acute treatment of agitation associated with dementia due to probable...
BioXcel Therapeutics Reports Positive Overall Survival Results from Single-Arm, Open-Label Phase 2 Trial of BXCL701 in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) of Adenocarcinoma Phenotype
November 08, 2023 07:00 ET
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BioXcel Therapeutics
Median overall survival of 15.5 months with BXCL701 + KEYTRUDA® (pembrolizumab), compared to 9.6 months with checkpoint inhibitor monotherapy in late-line refractory patients in separate Phase 2...
BioXcel Therapeutics Announces Update on NIDA-funded Trial of BXCL501 (sublingual dexmedetomidine) for Potential Treatment of Opioid Use Disorder (OUD)
November 06, 2023 07:00 ET
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BioXcel Therapeutics
Columbia University-led trial expected to add fourth site to target completion of 4-arm, 160-patient trial in 2024 Fentanyl adulterated or associated with xylazine (FAAX) designated an emerging...
BioXcel Therapeutics to Report Third Quarter 2023 Financial Results on November 14, 2023
October 31, 2023 07:00 ET
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BioXcel Therapeutics
NEW HAVEN, Conn., Oct. 31, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in...
BioXcel Therapeutics Receives Permanent J-Code for IGALMI™ (dexmedetomidine) Sublingual Film from Centers for Medicare & Medicaid Services
October 30, 2023 07:00 ET
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BioXcel Therapeutics
Standardizes and improves product reimbursement process New HCPCS Level II code J1105 to be effective January 1, 2024 NEW HAVEN, Conn., Oct. 30, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc....
BioXcel Therapeutics Announces Positive Findings from Independent Third Party Audit of Data Integrity at TRANQUILITY II Phase 3 Trial Site
October 25, 2023 07:00 ET
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BioXcel Therapeutics
No evidence of misconduct or fraud found beyond instance previously reported1 No findings identified that impact data integrity Company believes audit findings support reliability of positive...
BioXcel Therapeutics Reports Positive Overall Survival Results from Single-Arm, Open-Label Phase 2 Trial of BXCL701 in Patients with Small Cell Neuroendocrine Prostate Cancer
October 10, 2023 07:00 ET
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BioXcel Therapeutics
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...
BioXcel Therapeutics Provides Update on Recent Developments for Late-Stage Clinical Programs and Expansion of IP Portfolio for IGALMI™ (dexmedetomidine) Sublingual Film
October 04, 2023 07:00 ET
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BioXcel Therapeutics
Meetings scheduled with FDA in October and November for TRANQUILITY and SERENITY III programs Company strengthens IGALMI™ market exclusivity through receipt of two Notices of Allowance ...
BioXcel Therapeutics Reports Second Quarter 2023 Financial Results and Announces Strategic Reprioritization
August 14, 2023 07:00 ET
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BioXcel Therapeutics
Business to prioritize high-potential agitation market opportunities for BXCL501 in bipolar disorders, schizophrenia, and Alzheimer’s disease Commercial reprioritization intended to reduce related...
BioXcel Therapeutics to Report Second Quarter 2023 Financial Results on August 14, 2023
July 31, 2023 07:00 ET
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BioXcel Therapeutics
NEW HAVEN, Conn., July 31, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative...