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BioXcel Therapeutics, Inc. (NASDAQ: BTAI) is a biopharmaceutical company founded in 2017 and headquartered in New Haven, Connecticut. The company utilizes artificial intelligence to develop medicines in neuroscience and immuno-oncology. Its lead product, IGALMI (BXCL501), is an FDA-approved orally dissolving film for the acute treatment of agitation in adults with schizophrenia or bipolar I or II disorder.
Corporate Structure
BioXcel employs approximately 51 to 200 professionals across pharmaceutical research, clinical operations, AI drug discovery, and related functions. Collaborations with Columbia University, Yale University Medical School, and the University of North Carolina at Chapel Hill support its neuroscience pipeline. The Chief Executive Officer, Vimal D. Mehta, leads a management team focused on clinical development and regulatory strategy.
Biopharmaceutical Innovation by CDC
Developments and News
- August 13 and August 18, 2025: BioXcel confirmed its trademarks for IGALMI and updated professional resources for healthcare providers on its website.
- August 12, 2025: The company filed its Quarterly Report on Form 10-Q for the period ended June 30, 2025, with the SEC.
- August 15 and August 18, 2025: Two Current Reports on Form 8-K (Item 8.01) were filed, disclosing material corporate events.
- August 18, 2025: An independent Data Safety Monitoring Board recommended the continuation of the Phase 3 SERENITY At-Home trial assessing BXCL501 for agitation associated with bipolar disorders or schizophrenia. Enrollment in this pivotal trial was completed in Q1 2025.
Financial and Strategic Analysis
On August 18, 2025, BTAI closed at $6.93, reflecting an increase of 26.46% on a trading volume of 6.4 million shares. Key metrics as of mid-August 2025:
| Metric | Value |
|---|---|
| Stock price (Aug 18, 2025) | $6.93 |
| Daily price change | +26.46% |
| Trading volume | 6,401,217 shares |
| Market capitalization | $79.8 million |
| 52-week range | $1.17–$13.36 |
| Trailing twelve-month revenue | $0.87 million |
| Net loss (ttm) | –$50.95 million |
| Cash and equivalents (mrq) | $17.43 million |
| Beta (5Y monthly) | 0.06 |
| Average volume | 7.58 million |
BioXcel’s research and development focus centers on BXCL501, which has received Breakthrough Therapy designation for dementia-related agitation and Fast Track designation for agitation in schizophrenia and bipolar disorders. The company’s AI platform underpins early immuno-oncology programs, although these remain in the preclinical phase.
Market Position and Industry Context
Within the biotechnology sector, BioXcel operates in neuropsychiatric therapeutics and AI-driven drug discovery. IGALMI is recognized as one of the few orally administered formulations for acute agitation. Partnerships with leading academic institutions enhance its clinical development capacities, while FDA designations serve as important regulatory milestones. Advancing Phase 3 trial data will be essential for the company’s competitive positioning in a market that values clinical evidence and fast-tracked regulatory processes.
tl;dr
On August 18, 2025, BioXcel’s stock rose 26.46% to $6.93 after a Data Safety Monitoring Board recommended the continuation of its Phase 3 SERENITY At-Home trial for agitation in bipolar disorders and schizophrenia. The company reported having $17.4 million in cash and a market capitalization of $79.8 million, while progressing its lead asset under Breakthrough and Fast Track designations. Upcoming important events include Phase 3 efficacy results and further regulatory interactions.
