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...
BioXcel Therapeutics Announces Positive Topline Results From TRANQUILITY II Phase 3 Trial of BXCL501 for Acute Treatment of Alzheimer’s Disease-Related Agitation
June 29, 2023 06:00 ET
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BioXcel Therapeutics
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...
BioXcel Therapeutics to Participate at Two Upcoming Investor Conferences
June 01, 2023 07:00 ET
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BioXcel Therapeutics
NEW HAVEN, Conn., June 01, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative...
BioXcel Therapeutics Announces Promising Topline Results from Part 1 of Pivotal SERENITY III Trial of BXCL501 for At-Home Use in Acute Treatment of Agitation in Bipolar Disorders or Schizophrenia
May 25, 2023 07:00 ET
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BioXcel Therapeutics
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...
BioXcel Therapeutics Announces Positive Top-Line Data from Repeat Dosing of BXCL501 in Phase 1b Multiple Ascending Dose Trial in Healthy Volunteers for Major Depressive Disorder (MDD) Program
May 16, 2023 07:00 ET
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BioXcel Therapeutics
BXCL501 was well tolerated across a broad dose range from 30mcg to 140mcg administered chronically Planning Phase 2 human proof-of-concept study to evaluate BXCL501 as a potential adjunctive...