BioXcel Pursues FDA Approval for Expanded Label on Schizophrenia Therapy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Aug 27 2025
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Should l Buy BTAI?
Source: Benzinga
Trial Results: BioXcel Therapeutics' SERENITY At-Home Phase 3 trial for BXCL501, a sublingual film for acute agitation in bipolar disorder or schizophrenia, successfully met its primary endpoint with over 2,400 episodes showing consistent symptom reduction.
FDA Filing: The positive results will support an FDA supplemental filing to expand the label of Igalmi for at-home use, anticipated in Q1 2026.
Efficacy and Tolerability: A higher percentage of patients treated with BXCL501 achieved full resolution of agitation compared to placebo, with the 120 mcg dose being well-tolerated and causing no discontinuations.
Market Insights: Recent data suggests a significant increase in annual at-home agitation episodes in the U.S., estimating between 57–77 million, which is higher than previous estimates.
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Analyst Views on BTAI
Wall Street analysts forecast BTAI stock price to rise
2 Analyst Rating
1 Buy
0 Hold
1 Sell
Hold
Current: 1.540
Low
1.00
Averages
5.50
High
10.00
Current: 1.540
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.
See More
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.
See More
BioXcel Seeks FDA Approval for At-Home Use of IGALMI in Agitation Treatment
- At-Home Use Application: BioXcel plans to submit an sNDA this month seeking FDA approval for IGALMI's use in home settings to treat agitation associated with bipolar disorder or schizophrenia, addressing a significant gap in available management options for patients and caregivers.
- Market Potential: IGALMI generated net revenue of $98,000 in Q3 2025, down from $214,000 in the same period of 2024, indicating that approval for at-home use could lead to substantial market demand growth.
- R&D Progress: The sNDA submission aligns with BioXcel's advancements in the SERENITY and TRANQUILITY programs, which are evaluating IGALMI and investigational drug BXCL501 for neuropsychiatric indications, with BXCL501 already receiving Breakthrough Therapy designation.
- Future Outlook: CEO Vimal Mehta anticipates that IGALMI could be approved for at-home use as early as 2026, which would significantly transform the management of agitation outside clinical settings, enhancing patient quality of life.
See More
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- New Patient Care Perspective: BioXcel Therapeutics is set to host a virtual roundtable on December 8, focusing on the 57 to 77 million annual episodes of acute agitation associated with bipolar disorder and schizophrenia in the U.S., aiming to explore safe and effective self-administered treatment options at home to enhance patient care quality.
- Strong Expert Lineup: The event will feature leading medical experts, including Dr. Leslie Citrome, Clinical Professor of Psychiatry at New York Medical College, who will discuss shifts in treatment paradigms and future innovations, aiding clinicians and caregivers in better addressing patient needs.
- Industry-Wide Impact: With growing attention on the potential for home self-treatment, this roundtable not only provides crucial insights for investors and healthcare professionals but may also catalyze transformative changes in the acute mental health care sector.
- Interactive Engagement Opportunity: Attendees will have the chance to engage with experts through a written Q&A session, and a recording of the event will be made available on the BioXcel Therapeutics website, ensuring broader dissemination and application of knowledge.
See More
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- Patient Demand: With an estimated 57 to 77 million agitation episodes related to bipolar disorder and schizophrenia occurring annually in the U.S., the urgent need for safe and effective self-treatment options in home settings is highlighted, potentially reshaping the future of patient care.
- Expert Lineup: The roundtable will feature prominent medical experts, including Dr. Leslie Citrome from New York Medical College and Dr. Marc Milano from Newark Beth Israel Medical Center, sharing insights on future care models and facilitating cross-disciplinary knowledge exchange.
- Technological Innovation: BioXcel Therapeutics leverages artificial intelligence to develop transformative medicines in neuroscience, showcasing the company's potential in drug re-innovation, which may provide new treatment options for patients.
See More
BioXcel Therapeutics to Celebrate Major Neuroscience Achievement by Ringing Nasdaq Closing Bell on October 14
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Commitment to Mental Health: CEO Vimal Mehta emphasized the company's dedication to improving the lives of patients and families affected by mental illness, highlighting the successful completion of the SERENITY At-Home trial and the goal of bringing IGALMI® to patients in their homes.
See More
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.
See More
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.
See More
BioXcel Seeks FDA Approval for At-Home Use of IGALMI in Agitation Treatment
- At-Home Use Application: BioXcel plans to submit an sNDA this month seeking FDA approval for IGALMI's use in home settings to treat agitation associated with bipolar disorder or schizophrenia, addressing a significant gap in available management options for patients and caregivers.
- Market Potential: IGALMI generated net revenue of $98,000 in Q3 2025, down from $214,000 in the same period of 2024, indicating that approval for at-home use could lead to substantial market demand growth.
- R&D Progress: The sNDA submission aligns with BioXcel's advancements in the SERENITY and TRANQUILITY programs, which are evaluating IGALMI and investigational drug BXCL501 for neuropsychiatric indications, with BXCL501 already receiving Breakthrough Therapy designation.
- Future Outlook: CEO Vimal Mehta anticipates that IGALMI could be approved for at-home use as early as 2026, which would significantly transform the management of agitation outside clinical settings, enhancing patient quality of life.
See More
BioXcel Therapeutics Hosts Virtual Roundtable on Self-Administered Treatment Opportunities
- New Patient Care Perspective: BioXcel Therapeutics is set to host a virtual roundtable on December 8, focusing on the 57 to 77 million annual episodes of acute agitation associated with bipolar disorder and schizophrenia in the U.S., aiming to explore safe and effective self-administered treatment options at home to enhance patient care quality.
- Strong Expert Lineup: The event will feature leading medical experts, including Dr. Leslie Citrome, Clinical Professor of Psychiatry at New York Medical College, who will discuss shifts in treatment paradigms and future innovations, aiding clinicians and caregivers in better addressing patient needs.
- Industry-Wide Impact: With growing attention on the potential for home self-treatment, this roundtable not only provides crucial insights for investors and healthcare professionals but may also catalyze transformative changes in the acute mental health care sector.
- Interactive Engagement Opportunity: Attendees will have the chance to engage with experts through a written Q&A session, and a recording of the event will be made available on the BioXcel Therapeutics website, ensuring broader dissemination and application of knowledge.
See More
BioXcel Hosts Roundtable on Self-Administered Treatments for 77M Agitation Episodes
- Event Focus: BioXcel Therapeutics is set to host a virtual roundtable on December 8, discussing the opportunities and advantages of self-administered treatments, which is expected to attract participation from medical experts, investors, and caregivers, thereby fostering discussions on new treatment paradigms.
- Patient Demand: With an estimated 57 to 77 million agitation episodes related to bipolar disorder and schizophrenia occurring annually in the U.S., the urgent need for safe and effective self-treatment options in home settings is highlighted, potentially reshaping the future of patient care.
- Expert Lineup: The roundtable will feature prominent medical experts, including Dr. Leslie Citrome from New York Medical College and Dr. Marc Milano from Newark Beth Israel Medical Center, sharing insights on future care models and facilitating cross-disciplinary knowledge exchange.
- Technological Innovation: BioXcel Therapeutics leverages artificial intelligence to develop transformative medicines in neuroscience, showcasing the company's potential in drug re-innovation, which may provide new treatment options for patients.
See More
BioXcel Therapeutics to Celebrate Major Neuroscience Achievement by Ringing Nasdaq Closing Bell on October 14
BioXcel Therapeutics Nasdaq Closing Bell Ceremony: BioXcel Therapeutics, Inc. will ring the Nasdaq Stock Market Closing Bell on October 14, 2025, celebrating its advancements in treating agitation associated with bipolar disorders and schizophrenia.
Commitment to Mental Health: CEO Vimal Mehta emphasized the company's dedication to improving the lives of patients and families affected by mental illness, highlighting the successful completion of the SERENITY At-Home trial and the goal of bringing IGALMI® to patients in their homes.
See More
