Completes clinical trials required by FDA for sNDA submission planned for the first quarter of 2026NEW HAVEN, Conn., Oct. 14, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced positive results from the correlation study related to exploratory efficacy outcomes from the SERENITY At-Home trial. The results, along with the data from the SERENITY At-Home trial, wil ...

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].

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.

Core Insights - BioXcel Therapeutics, Inc. is leveraging artificial intelligence to develop transformative medicines in neuroscience and has a subsidiary focused on immuno-oncology [2] Group 1: Company Overview - BioXcel Therapeutics will present a company overview at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 4:30 p.m. Eastern Time [1] - The company utilizes a drug re-innovation approach, combining existing approved drugs with big data and proprietary machine learning algorithms to identify new therapeutic indications [2] Group 2: Upcoming Events - The presentation at the investment conference will be available via a live and archived webcast on the company's website [1]

Core Insights - BioXcel Therapeutics announced that BXCL501 achieved the primary endpoint of being well tolerated in the SERENITY At-Home trial for treating agitation episodes in patients with bipolar disorders or schizophrenia [1][2][3] - The company plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 for expanded usage of BXCL501 in outpatient settings without healthcare provider supervision [1][2][3] - The SERENITY At-Home trial treated over 2400 episodes of agitation, indicating a larger potential market opportunity for BXCL501 [1][2][3] Company Overview - BioXcel Therapeutics is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience [2][30] - BXCL501 is a proprietary sublingual film formulation of dexmedetomidine, currently FDA-approved for use in medically supervised settings [2][23][24] - The SERENITY At-Home trial is a pivotal Phase 3 study designed to evaluate the safety of BXCL501 for acute treatment of agitation in the home setting [2][22] Trial Results - The SERENITY At-Home trial was a double-blind, placebo-controlled study involving 246 patients, with 168 patients (81%) completing the full 12-week trial [6][22] - The 120 mcg dose of BXCL501 was well-tolerated, with no discontinuations due to tolerability issues [5][13] - Adverse events were consistent with the approved IGALMI label, with no new or unexpected treatment-emergent adverse events reported [13][19] Market Insights - Previous estimates indicated 23 million annual episodes of agitation, but new data suggests the total addressable market could be significantly higher, with estimates ranging from 57 million to 77 million episodes annually in the U.S. [19] - The majority of agitation episodes are believed to be moderate or severe, highlighting a significant unmet medical need for effective at-home treatments [19][26] - Physicians report underdiagnosis and undertreatment of agitation episodes in community settings, with only a third of patients receiving prescription drugs [19]

Core Viewpoint - BioXcel Therapeutics, Inc. is leveraging artificial intelligence to develop innovative medicines in the field of neuroscience and has announced a virtual fireside chat featuring its CEO, Vimal Mehta, on August 14, 2025 [1][2]. Company Overview - BioXcel Therapeutics, Inc. (Nasdaq: BTAI) focuses on utilizing artificial intelligence for the development of transformative medicines in neuroscience [2]. - The company has a subsidiary, OnkosXcel Therapeutics, which is dedicated to immuno-oncology drug development [2]. - BioXcel employs a drug re-innovation strategy that combines existing approved drugs and clinically validated candidates with big data and proprietary machine learning algorithms to discover new therapeutic uses [2].

Core Insights - BioXcel Therapeutics is set to release topline data from its SERENITY At-Home Phase 3 trial for the acute treatment of agitation associated with bipolar disorders or schizophrenia in August [1][2] - The company is preparing for a meeting with the FDA to support a potential supplemental New Drug Application (sNDA) for label expansion of IGALMI in the at-home setting [1][2] - Recent research indicates potential applications of BXCL501 in chronic conditions, enhancing its market prospects [1][4] Clinical Trials - The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 for treating agitation in bipolar disorders or schizophrenia at home [4][15] - The trial enrolled over 200 patients across 22 sites, with a balanced distribution between bipolar disorder and schizophrenia populations [6] - The TRANQUILITY In-Care Phase 3 trial is also underway, focusing on agitation associated with Alzheimer's dementia [6][16] Financial Performance - For Q2 2025, net revenue from IGALMI was $120 thousand, a significant decrease from $1.1 million in Q2 2024 [8] - Cost of Goods Sold for Q2 2025 was $107 thousand, up from $62 thousand in the same period last year [9] - Research and Development (R&D) expenses rose to $10.3 million in Q2 2025, compared to $8.0 million in Q2 2024, primarily due to increased clinical trial activities [10] Losses and Cash Position - The company reported an operating loss of $15.9 million and a net loss of $19.2 million for Q2 2025, compared to an operating loss of $17.3 million and a net loss of $8.3 million in Q2 2024 [12] - As of June 30, 2025, cash and cash equivalents totaled $18.6 million, not including an additional $11.5 million from sales and $3.6 million from warrant exercises [13][30]

Core Insights - BioXcel Therapeutics, Inc. is participating in a fireside chat at the Canaccord Genuity 45th Annual Growth Conference on August 12, 2025 [1] - The company utilizes artificial intelligence to develop transformative medicines in neuroscience and has a subsidiary focused on immuno-oncology [3] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company listed on Nasdaq under the ticker BTAI [3] - The company employs a drug re-innovation approach, leveraging existing approved drugs and big data to identify new therapeutic indications [3] Event Details - The fireside chat will take place at 12 p.m. ET and will be accessible via a webcast on the company's website [1][2] - A replay of the webcast will be available for 90 days following the event [2]

Core Insights - BioXcel Therapeutics has completed enrollment in its SERENITY At-Home pivotal Phase 3 safety trial for BXCL501, aimed at treating agitation associated with bipolar disorders or schizophrenia, with topline data expected in the second half of 2025 to support a potential sNDA submission for label expansion of IGALMI in the at-home setting [1][2] Company Updates - The SERENITY trial is designed as a double-blind, placebo-controlled study involving 200 patients, with over 165 patients already dosed and more than 115 receiving multiple doses during the 12-week trial period [7] - The company continues to supply IGALMI to patients and providers while building brand awareness with minimal commercial resources [4] Financial Performance - For Q1 2025, net revenue from IGALMI was $168,000, a decrease from $582,000 in Q1 2024 [5] - Cost of Goods Sold for Q1 2025 was $14,000, down from $80,000 in the same period last year [6] - Research and Development (R&D) expenses were $4.6 million for Q1 2025, significantly lower than $11.4 million in Q1 2024, primarily due to reduced clinical trial activity [8] - Selling, General and Administrative (SG&A) expenses decreased to $5.7 million in Q1 2025 from $13.3 million in Q1 2024, reflecting cost-cutting measures [9] - The company reported a net loss of $7.3 million for Q1 2025, compared to a net loss of $26.8 million for the same period in 2024, with cash and cash equivalents totaling $31 million as of March 31, 2025 [10] Product Development - BXCL501 is under investigation for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders or schizophrenia in the at-home setting, with Breakthrough Therapy and Fast Track designations granted by the FDA [11] - The TRANQUILITY In-Care Phase 3 trial is also in progress, designed to evaluate the efficacy and safety of BXCL501 for agitation associated with Alzheimer's dementia [13]