sNDA submission supports the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI® Submission timeline supports potential approval of IGALMI® label expansion as early as year-end 2026 NEW HAVEN, Conn., Jan. 20, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced it submitted a supple ...

Core Insights - BioXcel Therapeutics is highlighted as a promising penny stock due to its late-stage pipeline progress, increasing market potential, and an upcoming FDA milestone, making it a company to watch for 2026 [1] Company Overview - BioXcel Therapeutics is a biopharmaceutical company that utilizes artificial intelligence (AI) and machine learning to discover and develop innovative treatments, particularly in neuroscience [2] - The company's lead product, IGALMI, is an FDA-approved sublingual film formulation of BXCL501 designed for the immediate treatment of severe agitation in individuals with schizophrenia and bipolar disorder [2] Regulatory Developments - BioXcel has conducted a Phase 3 SERENITY At-Home trial with 246 patients to evaluate the safety of BXCL501 in a home-use setting, collecting data on over 2,600 agitation episodes [3] - The trial results showed no discontinuations due to tolerability, no major adverse events related to the drug, and no new safety signals, prompting the company to submit a supplemental New Drug Application (sNDA) to the FDA for at-home use of IGALMI [3] - The company anticipates FDA approval within the year and is preparing for pre-launch and commercial activities [3] Market Potential - BioXcel is advancing its TRANQUILITY In-Care Phase 3 program to address agitation associated with Alzheimer's dementia, having received FDA feedback on the clinical protocol [4] - The company estimates that the at-home agitation market in the U.S. represents between 57 million and 77 million episodes annually, significantly higher than previous estimates of 23 million episodes [5] - If approved, at-home IGALMI could fulfill a substantial unmet need by transitioning treatment from institutional settings to patients' homes, benefiting the patients [5]

Mark Pavao to Join BioXcel Therapeutics as Interim Chief Commercial Officer Mr. Pavao Brings Deep Experience in Neuroscience Sales and Marketing to Support Potential Launch of IGALMI® in At-Home Setting as Early as Year-End 2026 BioXcel Therapeutics on Track to Submit a sNDA for IGALMI® this Month NEW HAVEN, Conn., Jan. 12, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscienc ...

Financial Performance - The company reported a net loss of $30.9 million, or $2.18 per share, for the third quarter of 2025, compared to a net loss of $13.7 million, or $5.15 per share, in the same quarter last year [1] - Product revenues decreased to $98,000 from $214,000 year-over-year [1] Clinical Development Updates - BXCL501 showed a mean reduction in mCGI-S score from baseline compared to placebo at 2 hours during the SERENITY at-home phase 3 safety trial, indicating positive efficacy [2] - The SERENITY at-home supporting correlation study demonstrated a high correlation between validated clinician assessments and the mCGI-S scale, reinforcing its use as a measurement for exploratory efficacy outcomes [3] Future Plans - The company is preparing to initiate the TRANQUILITY In-Care Phase 3 Trial to evaluate BXCL501 for agitation associated with Alzheimer's dementia [4] - A supplemental New Drug Application for at-home use of IGALMI for the acute treatment of agitation related to bipolar disorders or schizophrenia is planned for submission in early Q1 2026 [4] - As of pre-market hours, the company's stock is trading at $1.9, reflecting a decline of 5.94 percent on the Nasdaq [4]

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].

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].