NEW YORK--(BUSINESS WIRE)--Halper Sadeh LLC, an investor rights law firm, is investigating whether certain officers and directors of BioXcel Therapeutics, Inc. (NASDAQ: BTAI) breached their fiduciary duties to shareholders. If you currently own BioXcel stock and are a long-term shareholder, you may be able to seek corporate governance reforms, the return of funds back to the company, a court-approved financial incentive award, or other relief and benefits. Please click here to learn more about. ...

Core Insights - BioXcel Therapeutics has completed clinical trials necessary for a supplemental New Drug Application (sNDA) submission, which is planned for the first quarter of 2026 [1] - The company reported positive results from the SERENITY At-Home trial, indicating a strong correlation between clinician assessments and patient/caregiver-rated outcomes [3][4] Group 1: Clinical Trial Results - The SERENITY At-Home trial showed a statistically significant correlation between the Positive and Negative Syndrome Scale – Excited Component (PEC) and the modified Clinical Global Impression – Severity Scale (mCGI-S), with correlation coefficients of ρ=0.89 for patients and ρ=0.88 for informants, both with p<0.0001 [3] - The mCGI-S scale was developed in consultation with the FDA to allow patients and caregivers to assess efficacy in an outpatient setting [2][6] Group 2: Safety and Efficacy - No serious adverse events were reported during the trials, and the safety profile of BXCL501 remains consistent with the existing IGALMI label [4] - BXCL501 is being investigated for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders in the at-home setting, with Breakthrough Therapy and Fast Track designations from the FDA [8] Group 3: Future Plans - The findings from the SERENITY At-Home study will be included in the upcoming sNDA package [4] - Additional data and results from the trials are expected to be presented at future medical meetings and conferences [5]

Core Insights - BioXcel Therapeutics, Inc. is celebrating a significant milestone by ringing the Nasdaq Stock Market Closing Bell, highlighting its progress in addressing unmet needs in psychiatry, particularly in treating agitation associated with bipolar disorders and schizophrenia [1][2]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company that leverages artificial intelligence to develop transformative medicines in neuroscience. The company also has a subsidiary, OnkosXcel Therapeutics, focused on immuno-oncology [3]. Recent Developments - The company has successfully completed its SERENITY At-Home pivotal trial, moving closer to its goal of redefining agitation management and bringing its product IGALMI® to patients in their homes [2]. - The Nasdaq Closing Bell ceremony is scheduled for October 14, 2025, and will be broadcast live [2]. Strategic Focus - BioXcel aims to transform the standard of care in neuropsychiatry by combining technology and compassion to deliver meaningful changes in patient care [2].

NEW HAVEN, Conn., Sept. 18, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it has received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has regained compliance with the market value of listed securities (“MVLS”) requirement under Nasdaq Listing Rule 5550(b)(2) (the “MVLS Rule”). As ...

Core Insights - BioXcel Therapeutics is making significant progress in expanding treatment options for managing acute agitation, particularly in home settings [3] - The company has reported positive exploratory efficacy results along with primary safety data, indicating a step forward in patient care [3] Company Overview - BioXcel Therapeutics aims to transform patient care by addressing the challenges faced by patients and families dealing with acute agitation [3] - The leadership team includes Vimal Mehta as CEO, Dr. Leslie Citrome as a clinical expert, and Dusan Kostic overseeing clinical and medical affairs [2]

Core Insights - BioXcel Therapeutics, Inc. released topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, showing that BXCL501 has continued effects and consistent benefits with repeat dosing [1] - The trial evaluated a 120 mcg dose of BXCL501 for agitation associated with bipolar disorders or schizophrenia, demonstrating significant efficacy compared to placebo [2] Efficacy Results - Across 2,433 treated episodes, BXCL501 showed a significant mean reduction in the modified Clinical Global Impression–Severity (mCGI-S) score from baseline compared to placebo at 2 hours [2] - Complete resolution of agitation symptoms was observed in 50% of patients in the BXCL501 arm compared to 33% in the placebo group [3] - Severe agitation episodes fully resolved in 61% of cases in the BXCL501 arm versus 18% on placebo, while moderate and mild episodes resolved in 43% and 60% of cases, respectively, compared to 34% and 40% on placebo [4] Dosage Impact - A mean reduction in mCGI-S score of 1.2 was noted after the first 12 doses, increasing to a mean reduction of 1.4 after 13 or more doses of BXCL501 [5] - Igalmi, the formulation of BXCL501, is currently FDA-approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings [5] Market Reaction - BioXcel Therapeutics shares increased by 3.07% to $3.69 at the time of publication, trading within a 52-week range of $1.17 to $13.36 [6]

Summary of BioXcel Therapeutics Conference Call Company Overview - **Company**: BioXcel Therapeutics (NasdaqCM:BTAI) - **Product**: IGALMI (dexmedetomidine) sublingual film - **Focus**: Treatment of acute agitation associated with schizophrenia and bipolar disorder Key Industry Insights - **Market Need**: There is a significant burden of agitation in patients with bipolar disorder and schizophrenia, with an estimated 60 to 80 million episodes occurring among 23 million patients in home settings [10] - **Current Treatment Gap**: Prior to IGALMI, there were no FDA-approved therapies for at-home treatment of agitation associated with these disorders [11] Core Findings from SERENITY At-Home Trial - **Trial Design**: The SERENITY At-Home trial was a double-blind, placebo-controlled study evaluating the safety and efficacy of a 120 microgram dose of IGALMI in an at-home setting [21] - **Patient Demographics**: Included 200 patients with a history of agitation, primarily diagnosed with schizophrenia or bipolar disorder, aged 18 to 75 [23][25] - **Efficacy Results**: - The trial demonstrated a significant reduction in agitation symptoms, with a responder rate of 40% for placebo and double that for IGALMI [14][15] - The number needed to treat (NNT) was 3, indicating that for every three patients treated, one additional patient experienced a significant reduction in agitation [17] - Complete resolution of agitation was significantly higher with IGALMI compared to placebo [28] Safety and Tolerability - **Adverse Events**: The safety profile was consistent with previous studies, showing no serious adverse events related to IGALMI. Somnolence rates were 22% for IGALMI and 6% for placebo in single doses [27] - **Repeated Dosing**: The drug was well tolerated with repeated dosing, maintaining efficacy without increased adverse events over time [30] Future Outlook - **Regulatory Submission**: A supplemental NDA for at-home use is planned for submission in Q1 2026 [12] - **Market Potential**: If approved, IGALMI could provide a new treatment option for managing acute agitation at home, potentially reducing hospital admissions and associated costs [70] Additional Considerations - **Patient Compliance**: The likelihood of patient compliance with at-home use is high if the drug is effective in managing agitation [72] - **Cost Sensitivity**: While cost may be a concern for inpatient providers, outpatient providers are generally less sensitive to price as long as the drug is accessible [70] Conclusion - BioXcel Therapeutics is positioned to address a significant unmet need in the management of acute agitation with IGALMI, supported by promising trial results and a clear regulatory pathway ahead. The focus on at-home treatment could transform patient care and reduce the burden on healthcare systems.

SERENITY At-Home Trial Overview - The SERENITY At-Home trial evaluated the safety and tolerability of BXCL501 (120 mcg) for agitation associated with bipolar disorder or schizophrenia in the at-home setting[2, 27, 28] - The trial design was a double-blind, placebo-controlled study with a 1:1 randomization to BXCL501 (N=100) or placebo (N=100) over a 12-week period[27] - The study included patients aged 18-75 years with bipolar I or II disorder, schizophrenia, schizoaffective, or schizophreniform disorder on a stable psychotropic regimen[30] Key Results - The trial collected data from 2,628 agitation episodes in 215 patients, with 2,437 episodes treated in 208 patients[21, 22, 36] - 168 (81%) of treated patients completed the full 12-week study, with an average of 117 agitation episodes recorded per treated patient[36] - No drug-related serious adverse events (SAEs), falls, or syncopes were reported in the BXCL501 arm[23, 37] - The adverse event profile was consistent with the approved IGALMI® label and other clinical trials in institutional settings[23, 37] - Somnolence was the most common treatment-emergent adverse event (TEAE) in the BXCL501 group, occurring in 23 (225%) of patients after the first dose and 161 (139%) of all doses[38] Clinical Benefit - BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes (P<005)[41] - Complete resolution of agitation was significantly higher with BXCL501 compared to placebo across agitation episode severity (P<0001)[41] - For fully resolved episodes by baseline severity, BXCL501 showed higher percentages than placebo across mild, moderate, and severe agitation episodes[43] Next Steps - BioXcel Therapeutics plans to prepare and submit an sNDA (supplemental New Drug Application) in Q1 2026 for label expansion of IGALMI®[12, 23]

Core Insights - BioXcel Therapeutics announced positive topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial for BXCL501, indicating significant benefits in treating agitation associated with bipolar disorders and schizophrenia [1][3][5] Efficacy Results - BXCL501 demonstrated a significant mean reduction in the modified Clinical Global Impression–Severity (mCGI-S) score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p<.05) [6] - Complete resolution of agitation symptoms was significantly higher with BXCL501 compared to placebo, with an overall resolution of 50% in the BXCL501 arm versus 33% on placebo (p <.0001) [7] - The mean reduction in mCGI-S score was maintained across repeated dosing, with a mean reduction of 1.2 after the first 12 doses and 1.4 after 13 or more doses [8] - The reduction in agitation symptoms was consistent throughout the 12-week trial duration, with a mean reduction of 1.3 in mCGI-S scores across all weeks [9] Trial Design and Patient Insights - The SERENITY At-Home trial was a double-blind, placebo-controlled study involving 246 patients, with data collected on 2,628 agitation episodes over 12 weeks [4][16] - The trial included patients with bipolar disorders (45%) and schizophrenia (55%), allowing for concomitant interventions to manage agitation episodes [4] - Patients reported an average of 11.7 agitation episodes during the trial, with 81% completing the full 12-week study [4] Market Opportunity - The total addressable market for at-home agitation treatment is estimated to be significantly higher than previously anticipated, with 57-77 million agitation episodes annually compared to an earlier estimate of 23 million [12] - The lack of FDA-approved therapies for at-home agitation treatment highlights a substantial unmet need in the market [11][12] Future Plans - Based on the positive trial results and FDA feedback, the company plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 for expanded usage of IGALMI® in outpatient settings [1][2][10]

Summary of BioXcel Therapeutics FY Conference Call Company Overview - **Company**: BioXcel Therapeutics (NasdaqCM:BTAI) - **Founded**: Became a public company in March 2018 - **Focus**: Development of transformative medicines in neuroscience utilizing artificial intelligence platforms [2][3] Key Product Information - **Product**: IGALMI - **Indication**: Acute treatment of agitation related to schizophrenia and bipolar disorder - **Current Approval**: Approved under medical supervision, not available in retail settings [3][4] - **Market Potential**: Initially estimated at 23 million episodes, revised to 57 to 77 million episodes in home settings [5][9] Recent Developments - **Phase 3 Trial**: Announced pivotal Phase 3 data for IGALMI, with plans to file a supplemental New Drug Application (sNDA) [2][8] - **Alzheimer's Agitation Program**: Positive Phase 3 trial completed; FDA has requested another confirmatory Phase 3 trial [5][20] Market Expansion Strategy - **Home Setting**: Focus on expanding IGALMI's use into home settings, targeting a larger patient population [5][9] - **Commercial Strategy**: Developing a strategy to bring IGALMI to patients, with potential approval in 2026 [9][19] Clinical Trial Insights - **SERENITY At-Home Trial**: Completed safety trial using the lowest approved dose of IGALMI; demonstrated safety and tolerability in home settings [8][16] - **Patient Data**: 2,437 agitation episodes treated in 208 patients; average of 11.7 episodes over 12 weeks [15][16] - **Safety Profile**: No treatment-emergent adverse events leading to discontinuation; consistent with approved IGALMI label [16][18] Future Plans - **sNDA Submission**: Expected in Q1 of 2026; non-clinical sections completed, clinical and CMC sections in progress [9][18] - **Alzheimer's Trial**: Plans to conduct a second confirmatory Phase 3 trial for Alzheimer's agitation in in-care settings [20] Market Opportunity - **Agitation as a Medical Need**: Significant unmet medical need for agitation treatment, especially in home settings; no FDA-approved therapies currently available for home use [10][17] - **Patient Distribution**: Approximately 50% of agitation episodes occur in in-care settings, highlighting the need for effective home treatment options [19][20] Conclusion - **Overall Outlook**: Positive momentum with ongoing trials and market expansion strategies; significant potential for IGALMI in both schizophrenia and Alzheimer's agitation [20][21]