BioXcel Seeks FDA Approval for At-Home Use of IGALMI® in Agitation Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 09 2026
0mins
Source: Newsfilter
- Application Progress: BioXcel Therapeutics plans to submit a supplemental New Drug Application (sNDA) this month seeking FDA approval for IGALMI® for at-home use in treating agitation associated with bipolar disorders or schizophrenia, with potential approval as early as 2026, thus providing a much-needed treatment option for patients.
- Market Demand: Currently, there are no FDA-approved options for at-home use of IGALMI® in acute agitation treatment, and BioXcel's application aims to fill this market gap, addressing urgent needs of patients and caregivers, which could significantly enhance the company's market share.
- Technological Innovation: IGALMI® is an orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist, and BioXcel is also investigating its use for acute agitation in Alzheimer's and bipolar disorders, showcasing the company's innovative potential in neuroscience.
- Regulatory Support: IGALMI® has received Breakthrough Therapy and Fast Track designations from the FDA, indicating its potential significance in treating acute agitation, further strengthening BioXcel's competitive position in the biopharmaceutical industry.
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Analyst Views on BTAI
Wall Street analysts forecast BTAI stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BTAI is 5.50 USD with a low forecast of 1.00 USD and a high forecast of 10.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
1 Buy
0 Hold
1 Sell
Hold
Current: 1.680
Low
1.00
Averages
5.50
High
10.00
Current: 1.680
Low
1.00
Averages
5.50
High
10.00
About BTAI
BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop medicines in neuroscience. Its subsidiary, OnkosXcel Therapeutics LLC, is focused on the development of medicines in immuno-oncology. Its advanced neuroscience candidate, BXCL501, is an investigational, orally dissolving film formulation of dexmedetomidine in development for the treatment of agitation associated with psychiatric and neurological disorders. It is continuing to develop BXCL501 for the potential acute treatment of agitation associated with bipolar disorder or schizophrenia in the at-home setting and for the potential acute treatment of agitation (non-daily) associated with dementia due to probable Alzheimer’s disease in the at-home setting and in care facilities. Its advanced immuno-oncology candidate, BXCL701, is an investigational oral innate immune activator for the treatment of aggressive forms of prostate cancer, pancreatic cancer, and other solid and liquid tumors.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Halper Sadeh Investigates BioXcel Therapeutics for Potential Breach of Fiduciary Duties
- Shareholder Rights Investigation: Halper Sadeh LLC is investigating whether certain officers and directors of BioXcel Therapeutics, Inc. breached their fiduciary duties to shareholders, potentially leading to corporate governance reforms and fund recovery.
- Legal Relief Options: Long-term shareholders of BioXcel stock may seek court-approved financial incentive awards or other relief measures, enhancing shareholder rights and company transparency.
- Importance of Participation: Shareholder involvement can improve the company's policies, practices, and oversight mechanisms, thereby increasing management transparency and accountability, which enhances shareholder value.
- Fee Arrangement: Halper Sadeh LLC will handle the case on a contingent fee basis, meaning shareholders will not be responsible for legal fees or expenses, reducing the financial burden of participation.
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BioXcel Seeks FDA Approval for At-Home Use of IGALMI® in Agitation Treatment
- Application Progress: BioXcel Therapeutics plans to submit a supplemental New Drug Application (sNDA) this month seeking FDA approval for IGALMI® for at-home use in treating agitation associated with bipolar disorders or schizophrenia, with potential approval as early as 2026, thus providing a much-needed treatment option for patients.
- Market Demand: Currently, there are no FDA-approved options for at-home use of IGALMI® in acute agitation treatment, and BioXcel's application aims to fill this market gap, addressing urgent needs of patients and caregivers, which could significantly enhance the company's market share.
- Technological Innovation: IGALMI® is an orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist, and BioXcel is also investigating its use for acute agitation in Alzheimer's and bipolar disorders, showcasing the company's innovative potential in neuroscience.
- Regulatory Support: IGALMI® has received Breakthrough Therapy and Fast Track designations from the FDA, indicating its potential significance in treating acute agitation, further strengthening BioXcel's competitive position in the biopharmaceutical industry.
Continue Reading