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BioXcel Therapeutics

NASDAQ: BTAI $0.85 USD~$10M (microcap trading near $1, July 2026) MCAP

BioXcel Therapeutics is a clinical-stage biopharmaceutical company leveraging artificial-intelligence–driven drug discovery to develop neuroscience and immuno-oncology medicines. Its lead commercial product IGALMI (sublingual dexmedetomidine) is FDA-approved for acute treatment of agitation associated with schizophrenia or bipolar I/II disorder, with an at-home sNDA under FDA review (PDUFA target action date November 14, 2026). The company is exploring strategic options for the IGALMI franchise after first-quarter 2026 IGALMI net revenue of $206K and an operating loss of $10.2M. Shareholders have previously authorized a 1-for-2 to 1-for-20 reverse split range to maintain Nasdaq bid-price compliance.

Company Info

Sector:Biopharmaceuticals / AI-Driven Drug Discovery (Neuroscience, Immuno-Oncology)
Headquarters:New Haven, Connecticut, USA
Founded:2017

Upcoming Milestones & Key Dates

November 14, 2026
Regulatory

FDA PDUFA target action date for IGALMI at-home sNDA

Q3 2026
Corporate

Q2 2026 financial results and IGALMI strategic-options update

Clinical Development Pipeline

IGALMI (sublingual dexmedetomidine) — at-home sNDA

Target: Alpha-2 adrenergic receptor agonist (sublingual dexmedetomidine)
Acute treatment of agitation associated with schizophrenia or bipolar I/II disorder in the at-home setting
Preclinical
Phase 1
Phase 2
Phase 3
Approved

BXCL501 (SERENITY At-Home program)

Target: Sublingual dexmedetomidine
At-home treatment of agitation in schizophrenia and bipolar disorders; Phase 3 SERENITY At-Home data presented at ASCP 2026
Preclinical
Phase 1
Phase 2
Phase 3
Approved

BXCL701

Target: Oral innate immune activator (dipeptidyl peptidase inhibitor)
Metastatic pancreatic ductal adenocarcinoma; metastatic castration-resistant prostate cancer (combination with KEYTRUDA)
Preclinical
Phase 1
Phase 2
Phase 3
Approved

Recent News

No recent news updates available for this company.

Leadership Team

Vimal Mehta, Ph.D.

Founder, Chief Executive Officer and Chief Scientific Officer

Careers & Job Openings

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Multiple Departments
New Haven, CT and remote
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